natgillin/translations-raw huggingface dataset:
Denne patientgruppe bør tage den orale suspension uden mad og på tom mave.
In this patient population, the oral suspension should be taken without food and on an empty stomach.
Andel med hiv-1-RNA < 50 kopier/ml
Proportion with HIV-1 RNA < 50 copies/ml
Hos 5 børn i alderen 6 til 24 måneder, der blev behandlet med 45 mg fosamprenavir/kg og 7 mg ritonavir/kg 2 gange daglig, blev det påvist, at på trods af en 5-fold stigning i doser af fosamprenavir og ritonavir, var AUC(0-) for amprenavir i plasma cirka 48 % lavere, Cmax 26 % lavere og C 29 % lavere hos børnene.
Compared to the historical adult population receiving fosamprenavir with ritonavir 700 mg / 100 mg twice daily, a subset of five pediatric subjects ages 6 to < 24-months receiving fosamprenavir / ritonavir 45/7 mg/kg twice daily demonstrated that despite an approximate 5-fold increase in fosamprenavir and ritonavir doses on a mg/kg basis, plasma amprenavir AUC(0-τ) was approximately 48 % lower, Cmax 26 % lower, and Cτ 29 % lower in the paediatric subjects.
Niveauet af amprenavir og ritonavir kan stige ved seponering af perikon.
Amprenavir and ritonavir levels may increase on stopping St John's wort.
300 mg én gang daglig
300 mg once daily
• hovedpine, svimmelhed
• Headache, feeling dizzy
Bemærk, at samtidig administration af Telzir med lavdosis ritonavir og sildenafil til behandling af pulmonal arteriel hypertension er kontraindiceret (se pkt.
Note that coadministration of Telzir with low dose ritonavir with sildenafil used for the treatment of pulmonary arterial hypertension is contraindicated (see section
(Kombineret CYP3A4induktion/hæmning)
(Mixed CYP3A4 induction/inhibition)
Paritaprevir (formuleret sammen med ritonavir og ombitasvir og administreret samtidig med dasabuvir)
ritonavir and ombitasvir other HIV protease inhibitors and co-administered with and paritaprevir/ritonavir/ dasabuvir)
BENZODIAZEPINER
BENZODIAZEPINES Midazolam
Naturlægemidler indeholdende perikon må ikke anvendes sammen med Telzir (se pkt.
Herbal preparations containing St John's wort must not be combined with Telzir (see section 4.3).
ETIKET TIL BEHOLDER TIL TABLETTER
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR TABLETS
Studiet er designet til at evaluere farmakokinetikken, sikkerheden, tolerancen og den antivirale aktivitet af fosamprenavir med og uden ritonavir hos børn i alderen 4 uger til 2 år.
APV20002 is a 48 week, Phase II, open label study designed to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of fosamprenavir with and without ritonavir in paediatric subjects 4 weeks to < 2 years of age.
Amprenavir: Cmax  13 %* Amprenavir: AUC  26 %* Amprenavir: Cmin  42 %* * sammenlignet med fosamprenavir / ritonavir 700 mg/100 mg 2 gange daglig
Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * compared to fosamprenavir / ritonavir 700 mg/100 mg twice daily
400 mg 2 gange daglig
400 mg twice daily
LPV/RTV 2 gange daglig (n=103)
LPV/RTV BID (N=103)
Andel med hiv-1-RNA < 400 kopier/ml
Proportion with HIV-1 RNA < 400 copies/ml
Børn kan tage voksendosis, én 700 mg Telzir tablet 2 gange daglig (sammen med 100 mg ritonavir 2 gange daglig), hvis de vejer mindst 39 kg og kan sluge tabletterne hele.
Children can take the adult dose of one 700 mg Telzir tablet twice daily (with ritonavir 100 mg twice daily) if they weigh at least 39 kg and can swallow the tablets whole.
Alder Kropsvægt Telzir dosis (2 GANGE DAGLIG)
Telzir dose (TWICE DAILY)
Efavirenz 600 mg én gang daglig
Efavirenz 600 mg once daily
Proteasehæmmere: Ifølge nuværende retningslinjer frarådes kombinationsbehandling med flere proteasehæmmere.
According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Paroxetin: Cmax  51 % Paroxetin: AUC 55 %
Paroxetine: Cmax ↓ 51% Paroxetine: AUC ↓ 55%
Rifampicin 600 mg én gang daglig
Rifampicin 600 mg once daily
Tag Telzir så længe som lægen har anbefalet.
Don't stop Telzir without advice Take Telzir for as long as your doctor recommends.
Lægemidler efter terapeutisk område
Drugs by Therapeutic Area Interaction
Cmax 51 % (-75 % til -3 %) AUC 55 % (-76 % til -16 %) Cmin 36 % (-57 % til -3 %)
AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
LPV/RTV - lopinavir / ritonavir.
Lopinavir / ritonavir
Methadon ≤ 200 mg én gang daglig
≤ 200 mg once daily
I et randomiseret åbent studie (APV30003) med proteasehæmmer-erfarne patienter, som havde virologisk svigt (< 2 PI'er) viste kombinationen med fosamprenavir og ritonavir (700/100 mg 2 gange daglig eller 1.400/200 mg én gang daglig) ikke non-inferioritet over for lopinavir/ritonavir med hensyn til viral suppression målt ved det gennemsnitlige areal under kurven minus baseline (AAUCMB) for plasma hiv-1-RNA over 48 uger (det primære endepunkt).
In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir combination (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
De filmovertrukne tabletter er lyserøde, kapselformede og bikonvekse.
Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.
Amprenavir Cmax  Amprenavir AUC  Amprenavir Cmin (C12h)  (Forhøjet gastrisk pH)
Amprenavir Cmax ↔ Amprenavir AUC ↔ Amprenavir Cmin (C12h) ↔
Ovennævnte studier viste samme bivirkningsprofil og samme kliniske laboratorieværdier som tidligere studier af hiv-1-inficerede personer med normal leverfunktion.
Fosamprenavir with ritonavir was generally well-tolerated in subjects with mild, moderate, or severe hepatic impairment, and these regimens had similar adverse event and clinical laboratory profiles as previous studies of HIV-1 infected subjects with normal hepatic function.
Hold fast om flasken og sæt plastikadaptoren i flaskehalsen.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
Patienter (%) med plasma-hiv1-RNA < 50 kopier/ml
Subjects (%) with plasma HIV-1 RNA <50 copies/ml
YDRE KARTON TIL TABLETTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TABLETS
: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Hos personer med svært nedsat leverfunktion (Child-Pugh score på 10-13) medførte en reduceret dosis af fosamprenavir på 300 mg 2 gange daglig i kombination med 100 mg ritonavir reduceret til én gang daglig en 19 % lavere plasma-Cmax, 23 % lavere plasma-AUC(0-12) og 38 % lavere plasma-C12værdier for amprenavir end hos personer med normal leverfunktion, som fik standardbehandlingen 700 mg fosamprenavir i kombination med 100 mg ritonavir 2 gange daglig.
In subjects with severe hepatic impairment (Child-Pugh score of 10-13), a reduced dose of fosamprenavir 300 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily delivered 19% lower plasma amprenavir Cmax, 23% lower AUC(0-12), and 38% lower C12 values, but similar unbound plasma amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Signifikant nedsat eksposition og Cmin er observeret for både amprenavir og raltegravir (især ved samtidig fødeindtagelse), hvilket kan medføre virologisk svigt hos nogle patienter.
amprenavir and raltegravir (especially in fed conditions) may result in virological
10. Sprøjten må ikke efterlades i flasken efter brug.
Do not leave the syringe in the bottle.
Til voksne med moderat nedsat leverfunktion (Child-Pugh Score: 7-9) er den anbefalede dosis 450 mg fosamprenavir (f.eks. 9 ml Telzir oral suspension) 2 gange daglig i kombination med 100 mg ritonavir en gang daglig.
For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir (i.e. 9 ml Telzir oral suspension) twice daily with 100 mg ritonavir once daily.
Rifabutin 150 mg hver anden dag
150 mg every other day
Hvis du holder op med at tage Telzir
If you take too much Telzir
Voksne patienter bør tage fosamprenavir oral suspension uden mad og på tom mave.
For adult patients the fosamprenavir oral suspension should be taken without food and on an empty stomach.
LPV/RTV 400 mg/100 mg 2 gange daglig (n=91)
LPV/RTV 400 mg/100 mg BID (n=91)
Patienter (%) med plasma-hiv1-RNA < 400 kopier/ml
Subjects (%) with plasma HIV-1 RNA <400 copies/ml
HMG-COAREDUKTASEHÆMMERE
HMG-COA REDUCTASE INHIBITORS
• Øvrige indholdsstoffer: hypromellose, sucralose, polysorbat 80, calciumchloriddihydrat, syntetisk grape-tyggegummismagsstof, naturligt pebermyntesmagsstof, renset vand, propylenglycol, methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216).
• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate,
Hver ml af suspensionen indeholder 50 mg fosamprenavir som fosamprenavircalciumsalt (svarende til ca. 43 mg amprenavir).
Each ml of suspension contains 50 mg of fosamprenavir as fosamprenavir calcium salt (equivalent to approximately 43 mg of amprenavir).
Lopinavir / ritonavir 400 mg/100 mg 2 gange daglig
400 mg/100 mg twice daily
Atazanavir: Cmax  24 %* Atazanavir: AUC 22 %* Atazanavir: Cmin* *sammenlignet med atazanavir/ ritonavir 300 mg/ 100 mg én gang daglig
Atazanavir: Cmax ↓ 24%* Atazanavir: AUC ↓ 22%* Atazanavir: Cmin↔* *compared to atazanavir/ ritonavir 300 mg/ 100 mg once daily
Baseline-hiv-1-RNA < 100.000 kopier/ml
All Subjects Baseline HIV-1 RNA < 100,000 copies/ml
Atorvastatindoser op til 20 mg/dag kan administreres.
Doses of atorvastatin no greater than 20 mg/day should be administered, with careful monitoring for atorvastatin toxicity.
Česká republika GlaxoSmithKline s.r.o.
GlaxoSmithKline s.r.o.
Hver tablet indeholder 700 mg fosamprenavir som fosamprenavircalcium (svarende til cirka 600 mg amprenavir).
Each tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg amprenavir).
Den sædvanlige dosis er én 700 mg Telzir tablet 2 gange daglig sammen med 100 mg ritonavir 2 gange daglig.
Adults The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily.
LPV/RTV 400 mg/100 mg 2 gange daglig (n = 444)
LPV/RTV 400 mg/100 mg BID (n=444)
43 patienter mødte studiedefinerede virologiske fejlkriterier gennem 48 uger i APV29005 og op til 108 uger i APV20003.
In the paediatric studies APV20003 and APV29005, 77 PI-experienced patients were treated with fosamprenavir / ritonavir-based regimens and 43 patients met study-defined virologic failure criteria through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Hvis du har en moderat leversygdom, er dosis 9 ml Telzir oral suspension (450 mg fosamprenavir) 2 gange daglig med 100 mg ritonavir kun én gang daglig.
If you have moderate liver disease the dose is 9 ml Telzir oral suspension (450 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
< 25 kg Ingen doseringsanbefalinger
Oral suspension should be taken with food <25 kg No dosing recommendations
Voksne bør tage Telzir oral suspension uden samtidig indtagelse af mad og på tom mave.
Adults should take Telzir oral suspension without food and on an empty stomach.
I forbindelse med studier af voksne patienter, som fik behandling med PI'er, observeredes følgende mutationer hos de patienter, der fik virologisk svigt: L10F/I/V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V, L90M og I93L/M.
In the studies of PI-experienced adult patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure: L10F/I/V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V, L90M and I93L/M.
Amiodaron:  forventet Bepridil:  forventet Quinidin:  forventet (FPV/RTV hæmmer CYP3A4)
Amiodarone: ↑ expected Bepridil: ↑ expected Quinidine: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Hvis du har en mild leversygdom, er den sædvanlige dosis én Telzir tablet (700 mg) 2 gange daglig med 100 mg ritonavir kun én gang daglig.
If you have mild liver disease, the dose is one Telzir tablet (700 mg) twice daily with 100 mg ritonavir only once daily.
FPV/RTV 700 mg/100 mg 2 gange daglig (n = 434)
FPV/RTV 700 mg/100 mg BID (n= 434)
Til voksne med let nedsat leverfunktion (Child-Pugh Score: 5-6) er den anbefalede dosis 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir en gang daglig.
For adults with mild hepatic impairment (Child-Pugh score: 5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Der skal udvises forsigtighed ved samtidig administration af Telzir/ritonavir og parenteral midazolam.
Telzir/ritonavir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Telzir/ritonavir and parenteral midazolam.
Forsigtighed tilrådes ved doser, der er større end de anbefalede (se pkt.
Caution is advised if the recommended dose of fosamprenavir with ritonavir detailed below are exceeded (see section 4.4).
Børn og unge: Bivirkningsprofilen hos børn og unge er baseret på integrerede sikkerhedsdata fra to studier (APV29005 uge 24 data og APV20003 uge 168 data [endelige data]).
Children and adolescents: The adverse reaction profile in children and adolescents is based on integrated safety data from two studies (APV29005 Week 24 data and APV20003 Week 168 data [final data]) in which 158 HIV-1 infected subjects 2 to 18 years of age received fosamprenavir with ritonavir with background nucleoside reverse transcriptase inhibitor therapy (see section 5.1 for information on dosing regimens applied for each age group).
Det skal du vide, før du begynder at tage Telzir Sådan skal du tage Telzir Bivirkninger
What Telzir is and what it is used for What you need to know before you take Telzir How to take Telzir
Didanosin-enterokapsel
Didanosine gastro-resistant capsule
Ethinylestradiol: Cmax 28 % Ethinylestradiol: AUC 37 %
Ethinyl estradiol: Cmax Ethinyl estradiol: AUC
Hver filmovertrukken tablet indeholder 700 mg fosamprenavir som fosamprenavircalcium (svarende til ca. 600 mg amprenavir)
Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)
Co. Durham DL12 8DT Storbritannien eller
Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom
Til voksne med moderat nedsat leverfunktion (Child-Pugh Score: 7-9) er den anbefalede dosis 450 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir en gang daglig.
For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
b) Patienter, der tidligere har været behandlet med PI'er Amprenavir
b) PI-experienced patients
Intrinsisk kortisolniveau: 
Fluticasone propionate: ↑ Intrinsic cortisol levels: ↓
1.000 - 10.000 kopier/ml
1000 - 10,000 copies/ml >10,000 - 100,000 copies/ml >100,000 copies/ml AAUCMB Observed Analysis
LÆGEMIDLER MOD INFEKTIONER
Medicinal products - interactions
Hvis du har en svær leversygdom, er dosis 6 ml Telzir oral suspension (300 mg fosamprenavir) 2 gange daglig med 100 mg ritonavir kun én gang daglig.
If you have severe liver disease the dose is 6 ml Telzir oral suspension (300 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Otte patienter mellem 12 og 18 år blev behandlet med tabletstandarddoseringen til behandling af voksne på 700 mg fosamprenavir 2 gange daglig (i kombination med 100 mg ritonavir 2 gange daglig).
In a clinical study on pharmacokinetics of fosamprenavir in paediatric patients, eight subjects 12 to 18 years of age received the standard fosamprenavir adult tablet dose of 700 mg twice daily (with ritonavir 100 mg twice daily).
Voksne bør tage den orale suspension uden mad og på tom mave.
In adults, the oral suspension should be taken without food and on an empty stomach.
Amprenavir: AUC  82 %
Amprenavir: AUC ↓ 82% Contraindicated (see section
Flecainid:  forventet Propafenon:  forventet (RTV hæmmer CYP2D6)
Propafenone: ↑ expected (CYP2D6 inhibition by RTV)
(RTV hæmmer i mindre grad CYP2D6)
(Mild CYP2D6 inhibition by RTV)
Norethisteron: Cmax 38 % Norethisteron: AUC 34 % Norethisteron: Cmin  26 % (FPV/RTV inducerer CYP3A4)
Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26
Samtidig behandling med Telzir og lavdosis ritonavir i kombination med rifampicin er kontraindiceret (se pkt.
Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated (see section 4.5).
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,
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 sections 4.3 and 4.5).
Hvis du har en mild leversygdom, er dosis 14 ml Telzir oral suspension (700 mg fosamprenavir) 2 gange daglig med 100 mg ritonavir kun én gang daglig.
If you have mild liver disease, the dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Film-coated tablets
Resultater fra studier med andre hiv-proteasehæmmere og paritaprevir/ritonavir/ombitasvir +/- dasabuvir antyder, at samtidig administration af fosamprenavir/ritonavir og paritaprevir/ritonavir/ombitasvir +/- dasabuvir sandsynligvis medfører øget plasmakoncentration af paritaprevir pga. CYP3A4enzymhæmning og højere ritonavir-dosis.
ombitasvir +/- dasabuvir suggest that coadministration of fosamprenavir/ritonavir with paritaprevir/ritonavir/ ombitasvir+/-dasabuvir is likely to lead to increased plasma exposures of paritaprevir due to CYP3A4 enzyme inhibition and higher ritonavir dose.
Resistente over for FPV/RTV ≥ 4 mutationer fra score
≥ 4 mutations from score
ANTIPSYKOTIKA
ANTIARRHYTHMICS
En ml oral suspension indeholder 50 mg fosamprenavir som fosamprenavircalcium (svarende til ca. 43 mg amprenavir).
Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg amprenavir).
Frarådes.
Not recommended.
Voksne patienter tidligere behandlet med antiretrovirale lægemidler
Antiretroviral Experienced Adult Patients
En ml oral suspension indeholder 50 mg fosamprenavir som fosamprenavircalcium (svarende til ca. 43 mg amprenavir)
Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir)
(FPV/RTV inducerer CYP3A4)
(CYP3A4 induction by FPV/RTV)
Oversigt over indlægssedlen Virkning og anvendelse
ANNEX III LABELLING AND PACKAGE LEAFLET
Børn kan tage en voksendosis på én 700 mg Telzir tablet 2 gange daglig sammen med 100 mg ritonavir 2 gange daglig, hvis de kan sluge tabletterne hele.
Children from 6 years of age and weighing at least 39 kg Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.
Integrasehæmmere
Potential for increased
Følgende mutationer blev påvist hos de patienter, der fik virologsik svigt i løbet af 96 uger: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V og L90M.
In the studies of PI-experienced adult patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V, and L90M.
Itraconazol:  forventet (FPV/RTV hæmmer CYP3A4)
Itraconazole: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Hos personerne med moderat nedsat leverfunktion (Child-Pugh score på 7-9) forventes en reduceret dosis af fosamprenavir på 450 mg 2 gange daglig i kombination med 100 mg ritonavir reduceret til én gang daglig at give samme plasma-Cmax and plasma-AUC(0-12) for amprenavir, som dem, der blev opnået hos personer med normal leverfunktion og som fik administreret 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritonavir 2 gange daglig.
In subjects with moderate hepatic impairment (Child-Pugh score of 7-9), a reduced dose of fosamprenavir 450 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily is predicted to deliver similar plasma amprenavir Cmax and AUC(0-12), but approximately 35 % lower plasma total amprenavir C12 values and approximately 88 % higher plasma unbound amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
For kraftig sprøjten bagtil i halsen kan øge risikoen for, at du får væsken galt i halsen.
Don't push too hard and squirt the liquid into the back of the throat or you may choke.
De nævnte mutationer sås kun sjældent, når ART-naive voksne patienter blev behandlet med de på nuværende tidspunkt godkendte doser af fosamprenavir/ritonavir.
The mutational profiles were similar to those described for PIexperienced adults treated with fosamprenavir / ritonavir.
Hos personerne med let nedsat leverfunktion sås en let forhøjet plasma-Cmax for amprenavir (17 %), en let forhøjet plasma-AUC(0-12) for amprenavir (22 %), tilsvarende totale plasma-C12-værdier for amprenavir og cirka 117 % højere plasma-C12-værdier for ubundet amprenavir.
In subjects with mild hepatic impairment (Child-Pugh score of 5-6), the dosage regimen of fosamprenavir 700 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily provided slightly higher plasma amprenavir Cmax (17 %), slightly higher plasma amprenavir AUC(0-12) (22 %), similar plasma total amprenavir C12 values and approximately 117 % higher plasma unbound amprenavir C12 values compared to subjects with normal hepatic function receiving the standard fosamprenavir / ritonavir 700 mg /100 mg twice daily regimen.
• træthed
• Feeling tired
Forhøjet kolesterol i blodet
Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased
Blødere kan bløde mere
Haemophiliacs may bleed more
For fosamprenavir var Cmax-værdien ca. 30 % lavere og Cmin-værdien ca. 28 % højere.
After multiple dose oral administration of equivalent fosamprenavir and amprenavir doses, comparable amprenavir AUC values were observed; however, Cmax values were approximately 30 % lower and Cmin values were approximately 28 % higher with fosamprenavir.
PDE5-hæmmere:  forventet (FPV/RTV hæmmer CYP3A4)
PDE5 inhibitors: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Lidocain:  forventet (FPV/RTV hæmmer CYP3A4)
Lidocaine: ↑ expected (CYP3A4 inhibition by FPV/RTV)
(FPV/RTV hæmmer CYP3A4)
(CYP3A4 inhibition by FPV/RTV)
Tabel over bivirkninger
Uncommon side effects
NEUROLEPTIKA
NEUROLEPTIC Pimozide
Kvalme eller opkastning, mavesmerter, løs afføring
• Feeling sick or being sick (nausea or vomiting), pain in the stomach, loose stools
Pimozid:  forventet (FPV/RTV hæmmer CYP3A4)
Pimozide: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Erythromycin:  forventet (FPV/RTV hæmmer CYP3A4)
Erythromycin: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Leversygdomme
Liver disease
Halofantrin:  forventet (FPV/RTV hæmmer CYP3A4)
Halofantrine: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Muskelproblemer
You may experience muscle problems
• hvis du lider af hæmofili (blødersygdom).
• If you have haemophilia.