natgillin/translations-raw huggingface dataset:
Data for andre CYP3A4hæmmere indikerer, at midazolamkoncentrationen bliver signifikant højere, når midazolam gives oralt.
Based on data with other protease inhibitors plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
• hvis du er allergisk over for fosamprenavir, amprenavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) eller over for ritonavir
• if you are allergic to fosamprenavir, amprenavir or any of the other ingredients of this medicine
YDRE KARTON TIL ORAL SUSPENSION
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR ORAL SUSPENSION
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2004
Samtidig administration af Telzir/ritonavir og alfuzosin er kontraindiceret (se pkt.
Co-administration of TELZIR/ritonavir with alfuzosin is contraindicated (see section 4.3).
• dolutegravir (mod hiv-infektion)
• dolutegravir (used to treat HIV infection)
Dihydroergotamin:  forventet Ergometrin:  forventet Ergotamin:  forventet Methylergometrin:  forventet
Ergonovine: ↑ expected Ergotamine: ↑ expected Methylergonovine: ↑ expected
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se. bilag I: Produktresumé, pkt.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Telzir er et antiretroviralt lægemiddel.
Telzir is a type of medicine known as an anti-retroviral.
PDE5-HÆMMERE
PDE5 INHIBITORS
Problemer med knoglerne
You may have problems with your bones
Hvis overdosering forekommer, bør patienten overvåges for tegn på toksicitet (se pkt.
If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8) and standard supportive treatment applied as necessary.
Cmax 25 % (-41 % til -4 %) AUC 25 % (-42 % til -3 %) Cmin 33 % (-50 % til -10 %)
Cmax ↓ 25% (-41%; -4%) AUC ↓ 25% (-42%; -3%) Cmin ↓ 33% (-50%; -10%)
Maraviroc 300 mg 2 gange daglig
Maraviroc 300 mg twice daily
Hepatitis C-virus (HCV) direkte virkende antivirale stoffer: Når hepatitis C-virus direkte virkende antivirale stoffer, som metaboliseres af CYP3A4, eller som er induktorer/hæmmere af CYP3A4, administreres samtidigt med fosamprenavir/ritonavir, kan ændrede plasmakoncentrationer forventes pga. hæmning eller induktion af CYP3A4-enzymaktivitet (se pkt.
Hepatitis C virus (HCV) Direct-Acting Antivirals: When hepatitis C virus direct-acting antiviral (DAA) drugs, which are metabolised by CYP3A4 or are inducers/inhibitors of CYP3A4, are coadministered with fosamprenavir/ritonavir, altered plasma concentrations of medications are expected due to inhibition or induction of CYP3A4 enzyme activity (see section 4.3 and 4.5).
Terapeutiske koncentrationsmålinger anbefales for tricykliske antidepressiva (f.eks. desipramin og nortriptylin), når disse administreres samtidig med Telzir (se pkt.
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e.g. desipramine and nortriptyline) when co-administered with Telzir (see section 4.5).
ViiV Healthcare Trading Services UK Limited 12 Riverwalk, Citywest Business Campus Dublin 24,
ViiV Healthcare Trading Services UK Limited 12 Riverwalk,
HDPE flaske med børnesikret låg af polypropylen.
HDPE bottles with a child resistant polypropylene closure containing 60 tablets.
Virkningsmekanisme
Efficacy Outcomes
Amprenavirs farmakokinetik i plasma blev undersøgt i et 14-dages ”repeat-dose”-studie med hiv-1inficerede voksne personer med let, moderat eller svært nedsat leverfunktion.
The plasma amprenavir pharmacokinetics were evaluated in a 14 day repeat-dose study in HIV-1 infected adult subjects with mild, moderate, or severe hepatic impairment receiving fosamprenavir with ritonavir compared to matched control subjects with normal hepatic function.
Sammenlignet med historiske data for voksne behandlet med samme doser havde de 12 til 18-årige 20 % lavere plasma APV AUC(0-24), 23 % lavere Cmax, og 20 % lavere Cmin-værdier.
Compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily, 12 to 18 year old subjects had 20 % lower plasma APV AUC(024), 23 % lower Cmax, and 20 % lower Cmin values.
• atorvastatin op til 20 mg om dagen (mod forhøjet kolesterol i blodet)
• atorvastatin up to 20 mg per day (used to lower cholesterol)
Den nuværende (juli 2006) ANRS AC-11-algoritme for fosamprenavir/ritonavir definerer resistens som tilstedeværelsen af mutationerne V32I+I47A/V, eller I50V eller mindst fire af følgende mutationer: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V og L90M.
The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V,
Patienter bør orienteres om, at Telzir eller enhver anden nuværende antiretroviral behandling ikke kurerer hiv.
Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Etravirin AUC 
Norethisterone: AUC
Baseret på de observerede eksponerings-responssammenhænge fra kliniske data anbefales dosisjustering af fosamprenavir eller dolutegravir ikke.
No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposureresponse relationships of clinical data.
Sådan skal du tage Telzir
How to take Telzir
pimozid (til behandling af skizofreni) quetiapin (til behandling af skizofreni, bipolar (manio-depressiv) lidelse og svær depressiv sygdom) lurasidon (til behandling af skizofreni og bipolar (manio-depressiv) lidelse cisaprid (til behandling af fordøjelsesbesvær) sekalealkaloider (til behandling af migræne) rifampicin (til behandling af tuberkulose) amiodaron, quinidin, flecainid og propafenon (hjertemedicin) bepridil (til behandling af forhøjet blodtryk) oral midazolam eller oral triazolam (til behandling af angst) naturlægemidler, der indeholder perikon (hypericum perforatum) lovastatin, simvastatin (til behandling af forhøjet kolesterol i blodet) sildenafil, hvis det bliver anvendt til behandling af pulmonal arteriel hypertension (en sygdom, der påvirker blodkarrene til lungerne) paritaprevir (til behandling af hepatitis C-virusinfektion).
- alfuzosin (used to treat a prostate problem) - astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription) - pimozide (used to treat schizophrenia) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - lurasidone (used to treat schizophrenia and bipolar disorder) - cisapride (used to relieve indigestion) - ergot derivatives (used to treat headaches) - rifampicin (used to treat tuberculosis) - amiodarone, quinidine, flecainide and propafenone (heart medicines) - bepridil (used to treat high blood pressure) - oral midazolam or oral triazolam (used to treat anxiety) - products containing St John's wort (Hypericum perforatum) - lovastatin, simvastatin (used to lower cholesterol) - sildenafil if used to treat pulmonary arterial hypertension, (a condition affecting the blood vessels to your lungs) - paritaprevir (used to treat hepatitis C virus infection)
• midazolam som injektion (mod angst)
• injectable midazolam (used to treat anxiety)
Oral suspension
PHARMACEUTICAL FORM Oral suspension
Amprenavir bindes hovedsageligt til alfa-1-syre glycoprotein (AAG), men også til albumin.
It is bound to the alpha-1acid glycoprotein (AAG) and albumin,but has a higher affinity for AAG.
Varigheden (median) af tidligere behandling med NRTI'er var 257 uger for patienter, som fik fosamprenavir og ritonavir 2 gange daglig (79 % havde tidligere fået  3 NRTI'er), og 210 uger for patienter, som fik lopinavir/ritonavir (64 % havde tidligere fået  3 NRTI'er).
The median durations of prior exposure to NRTIs were 257 weeks for patients receiving fosamprenavir with ritonavir twice daily (79 % had ≥ 3 prior NRTIs) and 210 weeks for patients receiving lopinavir/ritonavir (64 % had ≥ 3 prior NRTIs).
Den fulde produktinformation for ritonavir skal derfor læses før påbegyndelse af kombinationsbehandling med Telzir og ritonavir.
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
Telzir findes i plastbeholdere med 60 filmovertrukne tabletter.
What Telzir looks like and contents of the pack Telzir is supplied in plastic bottles containing 60 film-coated tablets.
Amprenavir: Cmax * Amprenavir: AUC * Amprenavir: Cmin * * sammenlignet med historiske data
Amprenavir: Cmax ↔* Amprenavir: AUC ↔* Amprenavir: Cmin ↔* * compared to historical data
Amprenavirs farmakokinetiske egenskaber efter samtidig administration af Telzir og ritonavir er undersøgt hos raske voksne forsøgspersoner og hos hiv-inficerede patienter.
The pharmacokinetic properties of amprenavir following co-administration of Telzir with ritonavir have been evaluated in healthy adult subjects and HIV-infected patients and no substantial differences were observed between these two groups.
Børn bør anvende Telzir oral suspension, idet den nøjagtige dosering til denne patientgruppe baseres på kropsvægt.
Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight.
APV29005 var et åbent, 48 ugers studie, som evaluerede den farmakokinetiske profil, sikkerheden og den antivirale aktivitet af fosamprenavir i kombination med ritonavir administreret 2 gange daglig hos hiv-1-positive patienter mellem 2 og 18 år.
The benefit in this age group has mainly been derived from study APV29005, an open label 48 week study evaluating the pharmacokinetic profiles, safety, and antiviral activity of fosamprenavir with ritonavir administered twice daily to HIV 1 protease inhibitor experienced and naive patients 2 to 18 years of age.
• raltegravir (mod hiv-infektion)
• raltegravir (used to treat HIV infection)
Den sædvanlige dosis er 14 ml Telzir oral suspension (700 mg fosamprenavir) 2 gange daglig sammen med 100 mg ritonavir (som kapsel eller oral opløsning) 2 gange daglig.
The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Fordelingsvolumenet af amprenavir efter administration af Telzir er ca. 430 l (6 1/kg ved en kropsvægt på 70 kg).
The apparent volume of distribution of amprenavir following administration of Telzir is approximately 430 l (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
25-32 kg Oral suspension
Oral suspension should be taken with food 25-32 kg Oral suspension
20 mg én gang daglig
20 mg once daily
I studiet ESS100732 fik 16 ud af 434 ART-naive patienter, der blev behandlet med 700 mg fosamprenavir/100 mg ritonavir 2 gange daglig, virologisk svigt efter 48 ugers behandling.
Sixteen of 434 ART-naïve patients who received fosamprenavir 700 mg/ritonavir 100 mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
These may affect up to 1 in 10 people:
Administration af 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir 2 gange daglig resulterer i plasmakoncentrationer af amprenavir med proteinjusterede mediane ratioer for Cmin/IC50 og Cmin/IC95 på henholdsvis 21,7 (interval 1,19-240) og 3,21 (interval 0,26-30,0) (data fra studie APV30003 af patienter, der tidligere er behandlet med antiretrovirale midler).
Administration of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily results in plasma amprenavir concentrations (data from study APV30003 in antiretroviral experienced patients) which results in protein adjusted median ratios of Cmin/IC50 and Cmin/IC95 of 21.7 (range 1.19-240) and 3.21 (range 0.26-30.0), respectively.
I dyrestudier blev der observeret tegn på udviklingstoksicitet ved systemiske amprenavirplasmaniveauer (AUC), som var lavere end det terapeutiske niveau hos patienter, som behandles med Telzir (se pkt.
In animal studies at systemic plasma exposures (AUC) to amprenavir lower than therapeutic exposure in patients treated with Telzir, some developmental toxicity was observed (see section 5.3).
Ved gentagen oral dosering af 700 mg fosamprenavir og 100 mg ritonavir 2 gange daglig blev amprenavir hurtigt absorberet med en maksimal steady state amprenavir-plasmakoncentration (Cmax) på 6,08 (5,38-6,86) g/ml (geometrisk gennemsnit (95 % CI)) ca. 1,5 (0,75-5,0) timer efter dosering (tmax).
After multiple dose oral administration of fosamprenavir 700 mg with ritonavir 100 mg twice daily, amprenavir was rapidly absorbed with a geometric mean (95 % CI) steady state peak plasma amprenavir concentration (Cmax) of 6.08 (5.38-6.86) µg/ml occurring approximately 1.5 (0.75-5.0) hours after dosing (tmax).
Amprenavirs distribution til cerebrospinalvæsken er ubetydelig hos mennesker.
CSF penetration of amprenavir is negligible in humans.
Baseline-hiv-1-RNA ≥ 100.000 kopier/ml
Baseline HIV-1 RNA ≥ 100,000 copies/ml
• Øvrige indholdsstoffer: mikrokrystallinsk cellulose, croscarmellosenatrium, povidon K30, magnesiumstearat, kolloid vandfri silica, hypromellose, titandioxid (E171), glyceroltriacetat, rød jernoxid (E172).
magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172).
Fosamprenavir og ritonavir bør seponeres permanent i tilfælde af alvorlige udslæt, eller i tilfælde af milde eller moderate udslæt ledsaget af systemiske eller mucosale symptomer (se pkt.
Fosamprenavir with ritonavir therapy should be definitively stopped in case of severe rash or in case of rash of mild or moderate intensity associated with systemic or mucosal signs (see section 4.4).
ORALE ANTIKOAGULANTIA
ORAL ANTICOAGULANTS
Resultater fra studier med andre hiv-proteasehæmmere og simeprevir eller daclatasvir antyder, at administration sammen med fosamprenavir/ritonavir sandsynligvis medfører øget plasmaniveau af simeprevir og daclatasvir pga. CYP3A4enzymhæmning.
Results from studies with other HIV protease inhibitors and simeprevir or daclatasvir, suggest that coadministration with fosamprenavir/ritonavir is likely to lead to increased plasma exposures of simeprevir or daclatasvir due to CYP3A4 enzyme inhibition.
Cmax 14 % (-36 % til +15 %) AUC 16 % (-36 % til +8 %) Cmin 19 % (-42 % til +13 %)
AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Den voksne dosering, en Telzir tablet på 700 mg i kombination med 100 mg ritonavir 2 gange daglig, kan anvendes til børn, hvis de vejer mindst 39 kg og kan sluge tabletter.
The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
> 100,000 kopier/ml, n (%) median CD4 celler/μl CD4-tal < 350 celler/μl, n (%) Effektresultat
Median CD4 cells/μl CD4 count < 350 cells/μl, n (%)
FPV/RTV 2 gange daglig (n=107)
FPV/RTV BID (N=107)
Etravirin Cmax 
Norethisterone: Cmax
4.3 og 4.5).
Results from studies with 4.3).
• hvis du er allergisk over for medicin, der indeholder sulfonamid, da du så også kan være allergisk over for Telzir
• If you have a known allergy to medicines containing sulphonamide.
Den induktive effekt kan vare i op til 2 uger efter seponering af perikon.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Vend flasken på hovedet.
Turn the bottle upside down.
Telzir må kun administreres i kombination med en lav dosis ritonavir og i kombination med andre antiretrovirale lægemidler.
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products.
Antibiotika:
INFECTION Antibacterials:
Varigheden (median) af sidste behandling med proteasehæmmere var 149 uger for patienter, som fik fosamprenavir og ritonavir 2 gange daglig (49 % havde tidligere fået  2 PI'er), og 130 uger for patienter, som fik lopinavir/ritonavir (40 % havde tidligere fået  2 PI'er).
The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49 % received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ritonavir (40 % received ≥2 prior PIs).
Hos rotteunger, der før og efter fødslen har været eksponeret for amprenavir og fosamprenavir, blev der observeret tegn på udviklingstoksicitet (se pkt.
Rat pups exposed pre and post-natally to amprenavir and fosamprenavir showed developmental toxicity (see section 5.3).
Lurasidon:  forventet (CYP3A4 hæmning)
Lurasidone: ↑ expected (CYP3A4 inhibition)
Hæmofilipatienter: Der er rapporteret om øget spontan blødningstendens hos hæmofilipatienter, som blev behandlet med proteasehæmmere (se pkt.
Haemophiliac patients: There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Rabdomyolyse: Der er i forbindelse med proteasehæmmere rapporteret om forhøjet CPK, myalgi og myositis.
Rhabdomyolysis: an increase in CPK, myalgia, myositis, and rarely, rhabdomyolysis, have been reported with protease inhibitors, more specifically in association with nucleoside analogues.
I langtidskarcinogenicitetsstudier af fosamprenavir sås stigninger i hepatocellulære adenomaer og hepatocellulære carcinomaer hos mus ved eksponeringsniveauer 0,1-0,3 gange større end den humane dosis på 700 mg fosamprenavir plus 100 mg ritonavir 2 gange daglig.
In long-term carcinogenicity studies with fosamprenavir in mice and rats, there were increases in hepatocellular adenomas and hepatocellular carcinomas in mice at exposure levels equivalent to 0.1 to 0.3-fold those in humans given 700 mg of fosamprenavir plus 100 mg ritonavir twice daily, and increases in hepatocellular adenomas and thyroid follicular cell adenomas in rats at exposure levels equivalent to 0.3 to 0.6-fold those in humans given 700 mg of fosamprenavir plus 100 mg ritonavir twice daily.
Amprenavir:  forventet (Beskeden CYP3A4-induktion)
Amprenavir: ↓ expected (Modest CYP3A4 induction)
Udslæt (se nedenfor under ”Udslæt/hudreaktioner”) Angioødem
Rash (see text below “rash/cutaneous reactions”)
Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om ritonavir eller anden medicin.
If you have any further questions about ritonavir or the other medicines prescribed, please ask your doctor or pharmacist.
• stigning i mængden af leverenzymer (transaminaser) og pancreasenzym (lipase)
• Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called lipase.
Filmovertrukne tabletter Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12 0DJ, Storbritannien.
Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain Oral suspension
Overfølsomhed over for fosamprenavir, amprenavir, ritonavir eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients listed in section
Du kan få udslæt, men du kan blive ved med at tage Telzir.
However you can still continue to take Telzir.
Nevirapin 200 mg 2 gange daglig
Nevirapine 200 mg twice daily
Den anbefalede dosis er 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir 2 gange daglig.
The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily.
Tabletterne er præget `GXLL7´ på den ene side.
The tablets are capsule shaped, biconvex, pink coloured and marked with ‘GXLL7' on one side.
Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Polysorbat 80
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Polysorbate 80
• atorvastatin doser på mere end 20 mg om dagen (mod forhøjet kolesterol i blodet)
• doses of atorvastatin greater than 20 mg per day (used to lower cholesterol)
I et randomiseret åbent studie (ESS100732 - KLEAN) hos antiretroviral-naive patienter, viste fosamprenavir (700 mg) med samtidig administration med en lavdosis ritonavir (100 mg) 2 gange daglig og en fast-dosis kombinationstablet af abacavir/lamivudin (600 mg/300 mg) én gang daglig, at have sammenlignelig effekt over 48 uger med lopinavir/ritonavir (400 mg/100 mg) givet 2 gange daglig i kombination med abacavir/lamivudin (600 mg/300 mg én gang daglig).
In a randomised open-label study (ESS100732 - KLEAN) in antiretroviral naïve patients, fosamprenavir (700 mg) co-administered with low dose ritonavir (100 mg) in a twice daily regimen including abacavir / lamivudine (600 mg / 300 mg) fixed dose combination tablet once daily showed comparable efficacy over 48 weeks to lopinavir / ritonavir (400 mg / 100 mg) given twice daily in combination with abacavir / lamivudine (600 mg / 300 mg once daily).
Til voksne med svært nedsat leverfunktion (Child-Pugh Score: 10-15) bør fosamprenavir anvendes med forsigtighed og i reduceret dosis på 300 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir en gang daglig.
For adults with severe hepatic impairment (Child-Pugh score: 10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
(Kombineret CYP3A4induktion/hæmning, Pglykoprotein-induktion)
(Mixed CYP3A4 induction/inhibition, Pgp induction)
Ikke-fastende
Not recommended
FPV/RTV 2 gange daglig vs LPV/RTV 2 gange daglig
FPV/RTV BID - Fosamprenavir with ritonavir twice daily, LPV/RTV BID - Lopinavir / ritonavir twice daily
Lægemidler - interaktioner Brugen af Telzir sammen med halofantrin eller lidocain (systemisk) kan ikke anbefales (se pkt.
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunsuppression, højere Body Mass Index (BMI)).
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Når Telzir tabletter og oral suspension blev administreret ved faste var plasma amprenavir AUC værdierne for de to formuleringer ækvivalente.
Telzir tablet and oral suspension formulations, both given fasted, delivered equivalent plasma amprenavir AUC∞ values and the Telzir oral suspension formulation delivered a 14 % higher plasma amprenavir Cmax as compared to the oral tablet formulation.
Voksne bør derfor tage Telzir oral suspension uden mad og på tom mave (se pkt.
Therefore for adult patients the Telzir oral suspension should be taken without food and on an empty stomach (see section 4.2).
Lopinavir: Cmax * Lopinavir: AUC * Lopinavir: Cmin * * sammenlignet med lopinavir / ritonavir 400 mg/100 mg 2 gange daglig
Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily
På trods af den reducerede doseringshyppighed af ritonavir havde personer med svært nedsat leverfunktion en 64 % højere plasma-Cmax, 40 % højere plasma-AUC(0-24) og 38 % højere plasma-C12-værdier for ritonavir i forhold til patienter med normal leverfunktion, der fik standardbehandlingen 700 mg fosamprenavir i kombination med 100 mg ritonavir 2 gange daglig.
Despite reducing the dosing frequency of ritonavir, subjects with severe hepatic impairment had 64% higher ritonavir Cmax, 40% higher ritonavir AUC(0-24), and 38% higher ritonavir C12 than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.