natgillin/translations-raw huggingface dataset:
Administration of the fosamprenavir oral suspension formulation with a high fat meal (967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) reduced plasma amprenavir AUC(0-∞) by 28% and Cmax by 46% and delayed Tmax by 0.72 hours.
kcal, 67 grama masti, 33 grama proteina, 58 grama ugljikohidrata) smanjila je vrijednost AUC(0-∞) za amprenavir u plazmi za 28% i Cmax za 46% te je produljila Tmax za 0,72 sata.
Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased
Povećanje kolesterola u krvi Povećanje triglicerida u krvi
Predicted exposures are based on extrapolation from data observed following administration of fosamprenavir 300 mg twice daily with ritonavir 100 mg once daily in subjects with moderate hepatic impairment.
Predviđene razine izloženosti temelje se na ekstrapolaciji iz podataka prikupljenih u ispitanika s umjerenim oštećenjem jetre nakon primjene fosamprenavira u dozi od 300 mg dvaput na dan u kombinaciji s ritonavirom u dozi od 100 mg jedanput na dan.
AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Cmax ↓ 14% (-36%; +15%) AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies, one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003).
Kliničko iskustvo Kliničko iskustvo s fosamprenavirom pojačanim ritonavirom uglavnom se temelji na 2 otvorena ispitivanja: prvom, na bolesnicima koji nisu primali raniju terapiju antiretrovirusnim lijekovima (ispitivanje ESS100732) i drugom, na bolesnicima koji su primali raniju terapiju antiretrovirusnim lijekovima (ispitivanje APV30003).
Non-nucleoside reverse transcriptase inhibitors:
Nenukleozidni inhibitori reverzne transkriptaze:
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
A i B bilo je prijava o pojačanim krvarenju tijekom uzimanja inhibitora proteaze.
Telzir tablets may be taken without regard to food intake.
Tablete lijeka Telzir mogu se uzimati neovisno o unosu hrane.
Cisapride
Učestalost
No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposureresponse relationships of clinical data.
Na temelju opaženih odnosa izloženosti-terapijskog odgovora iz kliničkih podataka prilagođavanje doze fosamprenavira ili dolutegravira se ne preporučuje.
Maraviroc: AUC12 ↑ 2.49 Maraviroc: Cmax ↑ 1.52
Maravirok: AUC12 ↑ 2,49
Median CD4 cells/μl CD4 count < 350 cells/μl, n (%)
>100,000 kopija/ml, n (%) Medijan CD4 stanica/μl broj CD4 stanica < 350 stanica/μl, n (%)
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.
Unatoč smanjenju učestalosti doziranja ritonavirom, ispitanici s teškim oštećenjem jetre imali su 64% višu vrijednost Cmax za ritonavir, 40% višu vrijednost AUC(0-24) za ritonavir i 38% višu vrijednost C12 za ritonavir od onih koje se postižu kod ispitanika s normalnom funkcijom jetre, a koji primaju standardni režim doziranja fosamprenavirom i ritonavirom 700 mg/100 mg 2 puta dnevno.
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Telzir u kombinaciji s niskom dozom ritonavira nije se pokazao jednako učinkovitim kao lopinavir/ritonavir kod odraslih osoba koje su umjereno liječene antiretrovirusnim lijekovima.
Note that co-administration of Telzir with low dose ritonavir with sildenafil used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Kontraindicirana je istodobna primjena lijeka Telzir i niskih doza ritonavira sa sildenafilom koji se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
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, I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
V32I+I47A/V ili I50V, ili barem četiri mutacije od: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V i L90M, i povezan je s povećanom fenotipskom rezistencijom na fosamprenavir s ritonavirom kao i sa smanjenjem vjerojatnošću virološkog odgovora (rezistencija).
(CYP3A4 induction by rifampicin)
(indukcija CYP3A4 rifampicinom)
Telzir 50 mg/ml oral suspension
Telzir 50 mg/ml oralna suspenzija
• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate,
• Drugi sastojci su: hipromeloza, sukraloza, polisorbat 80, kalcijev klorid dihidrat, umjetna aroma gume za žvakanje s okusom grožđa, prirodna aroma peperminta, pročišćena voda, propilenglikol,
Alternative non-hormonal methods of contraception are recommended for women of childbearing potential (see section 4.4).
nehormonske kontracepcijske metode (vidjeti dio 4.4).
Co-administration of ritonavir with fosamprenavir increase plasma amprenavir AUC by approximately 2-fold and plasma Cτ,ss by 4- to 6-fold, compared to values obtained when fosamprenavir is administered alone.
Uspoređujući s vrijednostima dobivenim kada se fosamprenavir primjenjuje samostalno, istodobna primjena ritonavira s fosamprenavirom povećava AUC amprenavira u plazmi za oko 2 puta, a vrijednost Cτ,ss u plazmi za 4 do 6 puta.
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).
U randomiziranom otvorenom ispitivanju (ESS100732 - KLEAN) na bolesnicima koji nisu primali raniju antiretrovirusnu terapiju, fosamprenavir (700 mg) istodobno primijenjen s niskom dozom ritonavira (100 mg) u režimu 2 puta na dan uz tabletu s fiksnom kombinacijom abakavira/lamivudina (600 mg / 300 mg) 1 put na dan i tijekom 48 tjedana, pokazana je usporediva djelotvornost prema lopinavir/ritonavir (400 mg / 100 mg) primijenjenom 2 puta dnevno u kombinaciji s abakavirom/lamivudinom (600 mg / 300 mg jednom dnevno).
Adults The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily.
Odrasli Preporučena doza je jedna tableta lijeka Telzir od 700 mg dva puta dnevno s 100 mg ritonavira dva puta dnevno.
Lopinavir / ritonavir 533 mg/133 mg twice daily
533 mg/133 mg 2 puta dnevno
Fluticasone propionate 50 µg intranasal 4 times daily) for 7 days
50 µg u nos, 4 puta dnevno) tijekom 7 dana
It may cause serious adverse reactions (see section 4.4).
Može uzrokovati ozbiljne nuspojave (vidjeti dio
• If you have diabetes.
• Bolujete li od dijabetesa.
(CYP2D6 inhibition by RTV)
(inhibicija CYP2D6 lijekom RTV)
Caution is advised if the recommended dose of fosamprenavir with ritonavir detailed below are exceeded (see section 4.4).
Preporučuju se mjere opreza u slučajevima kada su premašene preporučene doze fosamprenavira s ritonavirom navedene u nastavku (vidjeti dio 4.4).
Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common).
(3. i 4. stupnja) potencijalno povezanih s terapijom fosamprenavirom s ritonavirom, a koje su prijavljene u 1% ili više odraslih bolesnika, uključivale su: povećane razine ALT-a (često), AST-a
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.
Za odrasle s teškim oštećenjem jetre (Child-Pugh indeks: 10-15): fosamprenavir treba primijeniti oprezno, u smanjenoj dozi od 300 mg fosamprenavira 2 puta dnevno sa 100 mg ritonavira jedanput dnevno.
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.
U ispitivanjima na odraslim bolesnicima koji su ranije primali terapiju s IP, ispitivanju APV30003 i njegovoj ekstenziji, APV30005 (fosamprenavir 700 mg/ritonavir 100 mg 2 puta dnevno: n=107), kod bolesnika s virološkim neuspjehom kroz 96 tjedana pojavile su se sljedeće mutacije: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V i L90M.
Recommendation concerning coadministration
Preporuke za istodobnu primjenu
Shake the bottle for 5 seconds before subsequent uses.
Prije svake sljedeće primjene, protresite bočicu tijekom 5 sekundi.
All Subjects Baseline HIV-1 RNA < 100,000 copies/ml
Svi ispitanici Početna HIV-1 RNK < 100.000 kopija/ml
Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Telzir with ritonavir (see sections 4.3 and 4.5).
Stoga je potreban oprez pri istodobnoj primjeni lijeka Telzir i ritonavira s lijekovima koji induciraju, inhibiraju ili su supstrati CYP3A4 (vidjeti dijelove 4.3 i 4.5).
These may affect up to 1 in 1000 people:
Rijetke nuspojave mogu se javiti u manje od 1 na 1000 osoba:
stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response.
Telzir i ritonavirom treba pratiti antidepresivni odgovor.
Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4).
Preporučuju se mjere opreza u slučajevima kada su premašene preporučene doze lijeka Telzir s ritonavirom navedene u nastavku (vidjeti dio 4.4).
Telzir suspension is administered orally.
Suspenzija lijeka Telzir uzima se peroralno.
Anti-fungals: Ketoconazole
Ketokonazol
(CYP3A4 inhibition)
(inhibicija CYP3A4)
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.
Rezultati iz ispitivanja s drugim inhibitorima HIV proteaze i paritaprevirom/ritonavirom/ ombitasvirom +/- dasabuvirom ukazuju na to da će istodobna primjena fosamprenavira/ ritonavira s paritaprevirom/ ritonavirom/ombitasvirom +/dasabuvirom vjerojatno dovesti do povećanja plazmatske izloženosti paritapreviru zbog inhibicije enzima CYP3A4 i veće doze ritonavira.
Lovastatin: ↑ expected Simvastatin: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Lovastatin: očekuje se ↑ Simvastatin: očekuje se ↑ (inhibicija CYP3A4 lijekovima FPV/RTV)
Please refer to the table below for the dosing recommendations in paediatric patients.
Za preporuke doziranja u pedijatrijskih bolesnika molimo pogledajte niže navedenu tablicu.
Paroxetine
Paroksetin
Clinically significant hepatic transaminase elevations occurred in some subjects.
Kod nekih ispitanika došlo je do klinički značajnog povećanja jetrenih transaminaza.
and 6 patients from APV20003.
Ti podaci dodatno su potkrijepljeni suportivnim ispitivanjem APV20003.
Nervous system disorders
Poremećaji probavnog sustava Proljev
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).
U randomiziranom otvorenom ispitivanju (APV30003) na bolesnicima koji su primali raniju terapiju inhibitorima proteaze s virološkim neuspjehom (manje ili jednako 2 IP), kombinacija fosamprenavira s ritonavirom (700/100 mg 2 puta dnevno ili 1400/200 mg jednom dnevno) nije pokazala neinferiornost prema lopinaviru/ritonaviru s obzirom na supresiju virusa mjerenu prosječnom površinom ispod krivulje minus početne vrijednosti (AAUCMB) za HIV-1 RNK u plazmi tijekom razdoblja od 48
(R-) methadone: Cmax ↓ (R-) methadone: AUC ↓
(R-) metadon: Cmax ↓ (R-) metadon: AUC ↓ 18% (indukcija CYP lijekovima FPV/RTV)
(Mild CYP2D6 inhibition by RTV)
(Blaga inhibicija CYP2D6 lijekom RTV)
Amprenavir: Cmax ↔* Amprenavir: AUC ↔* Amprenavir: Cmin ↔* * compared to historical data
Amprenavir: Cmax ↔* Amprenavir: AUC ↔* Amprenavir: Cmin ↔* * u usporedbi s povijesnim podacima
In adults, the oral suspension should be taken without food and on an empty stomach.
Odrasli trebaju oralnu suspenziju uzeti bez hrane, na prazan želudac.
You need to know about important signs and symptoms to look out for while you're taking Telzir.
Tijekom uzimanja lijeka Telzir morate biti upoznati s važnim znakovima i simptomima na koje trebate pripaziti.
Your doctor will monitor your blood glucose levels before and during treatment with Telzir.
Prije početka i tijekom liječenja lijekom Telzir, liječnik će pratiti Vaše razine glukoze u krvi.
It may result in an increase in PDE5 inhibitor associated adverse reactions, including hypotension, visual changes and priapism (refer to PDE5 inhibitor prescribing information).
Može dovesti do povećanja broja nuspojava vezanih za PDE5 inhibitore, uključujući hipotenziju, promjene vida i prijapizam (pogledati u uputu o lijeku PDE5 inhibitora) Kada se PDE5 inhibitori uzimaju s lijekom Telzir/ritonavirom bolesnike treba upozoriti na te moguće nuspojave (vidjeti dio 4.4).
Patients with plasma HIV-1 RNA <400 copies/ml, Snapshot analysis Median change from baseline in CD4 cells
Bolesnici s razinom HIV-1 RNK u plazmi < 400 kopija/ml, analiza podataka prikupljenih samo pri jednom posjetu (engl. snapshot analysis)
AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
Cmax ↓ 51% (-75%; -3%) AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
Astemizole: ↑ expected Terfenadine: ↑ expected
Astemizol: očekuje se ↑ Terfenadin: očekuje se ↑
Rash / cutaneous reactions
Osip/kožne reakcije
Based on data with other protease inhibitors plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Temeljeno na podacima s drugim inhibitorima proteaze očekuje se da će koncentracije midazolama u plazmi biti značajno više ako se midazolam daje oralno. (inhibicija CYP3A4 lijekovima FPV/RTV)
Your doctor may lower your dose of Telzir and ritonavir depending on the amount of liver damage.
Ovisno o stupnju oštećenja jetre, liječnik će možda sniziti dozu lijeka Telzir i ritonavira.
- 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)
- rifampicin (koristi se za liječenje tuberkuloze) - amiodaron, kinidin, flekainid i propafenon (lijekovi za srce) - bepridil (koristi se za liječenje visokog krvnog tlaka) - oralni midazolam ili oralni triazolam (koriste se za liječenje tjeskobe) - pripravci koji sadrže Gospinu travu (Hypericum perforatum) - lovastatin, simvastatin (koriste se za snižavanje kolesterola)
Taking Telzir and food
Uzimanje hrane i pića s lijekom Telzir
Patients should be warned about these possible side effects when using PDE5 inhibitors with Telzir/ritonavir (see section 4.4).
promjene vida i prijapizam (pogledati u uputu o lijeku PDE5 inhibitora) Kada se PDE5 inhibitori uzimaju s lijekom Telzir/ritonavirom bolesnike treba upozoriti na te moguće nuspojave (vidjeti dio 4.4).
Oral use Read the package leaflet before use
Prije uporabe pročitajte uputu o lijeku.
Table 5.
PRILOG III.
These data were further substantiated by the supportive study APV20003; however, a different dosage regimen than that of study APV29005 was used.
Međutim, korišten je različit režim doziranja od onog u ispitivanju APV29005.
Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)
Jedna filmom obložena tableta sadrži 700 mg fosamprenavira u obliku fosamprenavirkalcija (što odgovara približno 600 mg amprenavira)
400 mg twice daily
400 mg 2 puta dnevno
Antiretroviral Experienced Adult Patients
Odrasli bolesnici koji su ranije primali antiretrovirusnu terapiju
ritonavir and ombitasvir other HIV protease inhibitors and co-administered with and paritaprevir/ritonavir/ dasabuvir)
Paritaprevir (u formulaciji s ritonavirom i ombitasvirom i primijenjen istodobno s dasabuvirom)
Proportion with HIV-1 RNA < 50 copies/ml
Udio sa HIV-1 RNK < 50 kopija/ml
(CYP3A4 inhibition by FPV/RTV)
(inhibicija CYP3A4 lijekovima FPV/RTV)
Cyclosporin: ↑ expected Rapamycin: ↑ expected Tacrolimus: ↑ expected
Ciklosporin: očekuje se ↑ Rapamicin: očekuje se ↑ Takrolimus: očekuje se ↑
Note that coadministration of Telzir with low dose ritonavir with sildenafil used for the treatment of pulmonary arterial hypertension is contraindicated (see section
Važno je primijetiti da je kontraindicirana istodobna primjena lijeka Telzir s malim dozama ritonavira i sildenafila koji se koristi za terapiju plućne arterijske hipertenzije (vidjeti dio
Other side effects of combination therapy for HIV
Ostale nuspojave u kombiniranoj terapiji za HIV Stare infekcije mogu se ponovno razbuktati
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.
Ako bolujete od umjerene bolesti jetre, doza je 9 ml Telzir oralne suspenzije (450 mg fosamprenavira) dva puta dnevno s 100 mg ritonavira samo jedan put dnevno.
- lopinavir/ritonavir combination (used to treat HIV infection) - raltegravir (used to treat HIV infection) - , , simeprevir, daclatasvir (used to treat hepatitis C virus infection) - maraviroc (used to treat HIV infection)
• raltegravir (koristi se za liječenje HIV infekcije) • simeprevir i daklatazvir (koriste se za liječenje infekcije virusom hepatitisa C)
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.
Ako bolujete od teške bolesti jetre, doza je 6 ml Telzir oralne suspenzije (300 mg fosamprenavira) dva puta dnevno s 100 mg ritonavira samo jedan put dnevno.
You will be closely monitored if you are taking these medicines with Telzir/ritonavir:
• maravirok (koristi se za liječenje HIV infekcije) Pozorno će se pratiti Vaše stanje ako s lijekom Telzir/ritonavirom uzimate sljedeće lijekove:
Oral suspension should be taken with food 25-32 kg Oral suspension
25-32 kg Oralna suspenzija 18 mg/kg (0,36 ml/kg ) Oralnu suspenziju treba uzimati s hranom
Telzir with ritonavir should be used with caution and at reduced doses in adults with mild, moderate, or severe hepatic impairment (see section 4.2).
Kod odraslih bolesnika s blagim, umjerenim ili teškim oštećenjem jetre Telzir s ritonavirom treba se primjenjivati oprezno i u smanjenim dozama (vidjeti dio 4.2).
ORAL CONTRACEPTIVES Ethinyl estradiol 0.035 mg/norethisterone 0.5 mg once daily
Etinil estradiol: Cmax ↓28% Za žene koje mogu zatrudnjeti mg/noretisteron 0,5 mg jednom dnevno
Proportion with HIV-1 RNA < 400 copies/ml
Udio s HIV-1 RNK < 400 kopija/ml
Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated (see section 4.5).
Kontraindicirana je istodobna primjena rifampicina i lijeka Telzir s niskom dozom ritonavira (vidjeti dio 4.5).
If you are breast-feeding, or thinking about breast-feeding: →Talk to your doctor immediately.
Ako dojite ili ste razmišljali o dojenju:
Amprenavir (APV) pharmacokinetics were studied in pregnant women receiving FPV/RTV 700/100 mg twice daily during the second trimester (n=6) or third trimester (n=9) and postpartum.
700/100 mg dvaput na dan tijekom drugog (n=6) ili trećeg tromjesečja trudnoće (n=9) te nakon poroda.
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.
Kod odraslih s umjerenim oštećenjem jetre (Child-Pugh indeks: 7-9) preporučena doza je 450 mg fosamprenavira (tj. 9 ml Telzir oralne suspenzije) 2 puta dnevno sa 100 mg ritonavira jedanput dnevno.
Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (see section 4.8).
U slučaju teškog osipa ili osipa umjerenog intenziteta sa sistemskim ili mukoznim simptomima treba razmotriti privremeno ili trajno obustavljanje liječenja lijekom Telzir (vidjeti dio 4.8).
A 10 ml graduated dosing syringe and an adapter are also included in the pack.
U pakiranju su također priloženi graduirana odmjerna štrcaljka od 10 ml i nastavak.
Amprenavir ↓ expected (CYP3A4 induction by St. John's wort)
Amprenavir očekuje se ↓ (indukcija CYP3A4 Gospinom travom)
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.
Za odrasle s blagim oštećenjem jetre (Child-Pugh indeks: 5-6) preporučena doza je 700 mg fosamprenavira dva puta dnevno sa 100 mg ritonavira jedanput dnevno.
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.
Kod ispitanika s umjerenim oštećenjem jetre (Child-Pugh indeks 7-9) predviđa se da bi smanjena doza fosamprenavira od 450 mg 2 puta dnevno uz smanjenu učestalost doziranja ritonavirom od 100 mg jednom dnevno dala slične vrijednosti Cmax i AUC(0-12) amprenavira u plazmi, ali s oko 35 % nižom ukupnom vrijednosti C12 amprenavira u plazmi i oko 88% višim vrijednostima C12 za nevezani amprenavir od onih koje se postižu kod ispitanika s normalnom funkcijom jetre a koji primaju standardni režim doziranja fosamprenavirom i ritonavirom 700 mg/100 mg 2 puta dnevno.
For adult patients the fosamprenavir oral suspension should be taken without food and on an empty stomach.
Odrasli bolesnici trebaju oralnu suspenziju fosamprenavira uzeti bez hrane, na prazan želudac.
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.
Ako bolujete od blage bolesti jetre doza je 14 ml Telzir oralne suspenzije (700 mg fosamprenavira) dva puta dnevno s 100 mg ritonavira samo jedan put dnevno.
Not studied.
Nisu ispitivani.