natgillin/translations-raw huggingface dataset:
No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Nisu identificirana nova sigurnosna pitanja u analizama podataka nakon 48 tjedana iz ispitivanja APV29005 ili APV20002, u kojima su 54 ispitanika u dobi od 4 tjedna do < 2 godine primala fosamprenavir/ritonavir dvaput na dan uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze, dok je 5 ispitanika primilo samo jednokratnu dozu fosamprenavira s ritonavirom ili bez njega.
400 mg/100 mg twice daily
400 mg/100 mg 2 puta dnevno
Please refer to the table below for the dosing recommendations in adults.
Za preporuke doziranja u odraslih molimo pogledajte niže navedenu tablicu.
Very common side effects These may affect more than 1 in 10 people:
Vrlo česte nuspojave mogu se javiti u više od 1 na 10 osoba:
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There are insufficient data to recommend the use of fosamprenavir with ritonavir in heavily pre-treated patients.
Nema dovoljno podataka da bi se preporučila primjena fosamprenavira s ritonavirom kod bolesnika koji su ranije primali snažno antiretrovirusno liječenje.
Remove the bottle cap and keep it safely.
2. Uklonite zatvarač s boce i pospremite ga.
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).
Medijan trajanja prethodne izloženosti NRTI bio je 257 tjedana za bolesnike koji su primali fosamprenavir s ritonavirom 2 puta dnevno (79 % imalo je ≥ 3 ranije NRTI) i 210 tjedana za bolesnike koji su primali lopinavir/ritonavir (64 % imalo je ≥ 3 ranije NRTI).
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Tijekom primjene lijeka Telzir ne smiju se koristiti biljni pripravci koji sadržavaju Gospinu travu (Hypericum perforatum) zbog rizika od smanjenja koncentracije u plazmi i smanjenog kliničkog učinka amprenavira (vidjeti dio 4.5).
Table 5 Baseline Characteristics and Efficacy Outcomes at Week 48 in APV29005 ITT(E) Population
Tablica 5 Početne značajke i ishodi djelotvornosti u 48. tjednu u ITT(E) populaciji iz ispitivanja APV29005
Paroxetine: Cmax ↓ 51% Paroxetine: AUC ↓ 55%
Paroksetin: Cmax ↓ 51% Paroksetin: AUC ↓55%
• Headache, feeling dizzy
• glavobolja, osjećaj omaglice • osjećaj umora
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Kod istodobne primjene fosamprenavira i ritonavira, metabolički profil ritonavira u interakcijama lijekova može biti predominantan budući da je ritonavir potentniji inhibitor
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.
U ispitivanjima dugotrajne karcinogenosti fosamprenavira provedenim na miševima i štakorima zamijećeno je povećanje hepatocelularnih adenoma i hepatocelularnih karcinoma kod miševa pri razinama izloženosti ekvivalentnim od 0,1 do 0,3-puta od onih koje nalazimo kod ljudi kod doze od 700 mg fosamprenavira sa 100 mg ritonavira 2 puta dnevno, kao i povećanje hepatocelularnih adenoma i adenoma folikularnih stanica štitnjače kod štakora pri razinama izloženosti od 0,3 do 0,6
If you have moderate or severe liver disease the dose of Telzir has to be lowered.
Ako bolujete od umjerene ili teške bolesti jetre, doza lijeka
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended (see section
Preporučuje se pažljivo praćenje terapijskih reakcija i nuspojava tricikličkih antidepresiva (vidjeti dio 4.4).
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
Stoga se, prije početka terapije lijekom Telzir s ritonavirom, moraju konzultirati sve informacije o propisivanju ritonavira.
CSF penetration of amprenavir is negligible in humans.
Prodor amprenavira u cerebrospinalni likvor kod ljudi je zanemariv.
Increased plasma concentrations of quetiapine may lead to coma.
Povećane koncentracije kvetiapina u plazmi mogu izazvati komu.
Efficacy Outcomes
Ishodi djelotvornosti
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e.g. desipramine and nortriptyline) when coadministered with Telzir (see section 4.5).
Preporučuje se praćenje terapijske koncentracije tricikličkih antidepresiva (npr. desipramina i nortriptilina) kada ih se primjenjuje istodobno s lijekom Telzir (vidjeti dio 4.5).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR ORAL SUSPENSION
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA ZA ORALNU SUSPENZIJU
20 mg once daily
20 mg jednom dnevno
Reinforced monitoring of the International Normalised Ratio is recommended (see section 4.4).
Preporučuje se pojačano praćenje Međunarodnog normaliziranog omjera - INR (vidjeti dio 4.4).
Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Zbog smanjene koncentracije amprenavira u plazmi, Telzir može biti manje učinkovit kod bolesnika koji istodobno primaju navedene lijekove (vidjeti dio 4.5).
Let them dry completely before you use them again.
Pazite sa se prije ponovne primjene osuše u potpunosti.
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).
Nakon peroralne primjene višestrukih doza fosamprenavira od 700 mg s ritonavirom od 100 mg 2 puta dnevno amprenavir je brzo apsorbiran s geometrijskom srednjom vrijednosti (95% CI) vršne koncentracije amprenavira u plazmi pri stanju dinamičke ravnoteže (Cmax) od 6,08 (5,38-6,86) µg/ml do koje dolazi oko 1,5 (0,75-5,0) sati nakon doziranja (tmax).
Telzir tablet is administered orally.
Tablete Telzir primjenjuju se peroralno.
Rhabdomyolysis: an increase in CPK, myalgia, myositis, and rarely, rhabdomyolysis, have been reported with protease inhibitors, more specifically in association with nucleoside analogues.
Rabdomioliza: pri korištenju inhibitora proteaze, više specifično s analozima nukleozida, prijavljene su povećane vrijednosti CPK, mialgija, miozitis i rijetko rabdomioliza.
Increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis.
Povećane koncentracije inhibitora HMG-CoA reduktaze mogu uzrokovati miopatiju,
Other oral anticoagulants
Drugi oralni antikoagulansi
• desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression)
• dolutegravir (koristi se za liječenje infekcije HIV-om) • dezipramin, nortriptilin, paroksetin i slične lijekove (koriste se za liječenje depresije)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA ZA TABLETE
Phenytoin: Cmax ↓ 20% Phenytoin: AUC ↓ 22% Phenytoin: Cmin ↓ 29%
Fenitoin: Cmax ↓ 20% Fenitoin: AUC ↓ 22% Fenitoin: Cmin ↓ 29%
Telzir 50 mg/ml oral suspension Fosamprenavir
Telzir 50 mg/ml oralna suspenzija fosamprenavir
Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * compared to fosamprenavir / ritonavir 700 mg/100 mg twice daily
Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * u usporedbi s fosamprenavirom / ritonavirom 700 mg/100 mg 2 puta dnevno
Fosamprenavir tablets and oral suspension with ritonavir in combination with NRTIs have been evaluated in protease inhibitor naïve and experienced children and adolescent patients.
Tablete i oralna suspenzija fosamprenavira s ritonavirom u kombinaciji s NRTI procjenjivani su kod dječjih i adolescentnih bolesnika i kod onih koji su primali i kod onih koji nisu ranije primali terapiju inhibitora proteaze.
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.
Primjena fosamprenavira u dozi od 700 mg 2 puta dnevno s ritonavirom u dozi od 100 mg 2 puta dnevno rezultira koncentracijama amprenavira u plazmi (podaci iz ispitivanja APV30003 na bolesnicima koji su ranije primali antiretrovirusnu terapiju) koja dovodi do prilagođenog proteinskog medijana u omjeru Cmin/IC50 i Cmin/IC95 od 21,7 (raspon 1,19-240) odnosno 3,21 (raspon 0,26-30,0).
Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients)
Tablica 1 Ishod djelotvornosti u 48. tjednu u ESS100732 (bolesnici koji nisu ranije primali antiretrovirusnu terapiju)
18 mg/kg (0.36 ml/kg ); maximum 700 mg or 14 ml
33-38 kg Oralna suspenzija 18 mg/kg (0,36 ml/kg ); najviše 700 mg ili 14 ml Oralnu suspenziju treba uzimati s hranom
In case of concomitant administration with antineoplastic agents metabolized by CYP3A, please refer to the relevant product information for these medications.
U slučaju istodobne primjene s antineoplasticima koji se metaboliziraju putem CYP3A, potrebno je vidjeti sažetak opisa svojstava lijeka za te lijekove.
Co-administration of Telzir 700 mg twice daily with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated.
Istodobna primjena lijeka Telzir od 700 mg dva puta dnevno s dozama ritonavira većim od 100 mg, dva puta na dan, nije klinički ispitana.
When antineoplastic agents that are metabolised by CYP3A are co-administered with fosamprenavir/ritonavir, plasma concentrations of these antineoplastic medications may be increased and could increase the risk of adverse events usually associated with these antineoplastic agents.
Kada se istodobno s fosamprenavirom/ritonavirom primjenjuju antineoplastici koji se metaboliziraju putem CYP3A, može se povećati koncentracija antineoplastika u plazmi, što može povećati rizik od štetnih događaja koje se obično povezuje s tim antineoplasticima.
In addition, decreased number of implantation sites per litter and a prolongation of gestation were seen when pups were mated after reaching maturity.
Nadalje, pri parenju mladunčadi nakon dosezanja odrasle dobi, zamijećen je smanjeni broj mjesta implantacije po leglu te produljenja gestacije.
Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone (see section 4.5).
Telzir s ritonavirom ne smije se istodobno primjenjivati s lijekovima koji imaju usku terapijsku širinu, a koji su visoko ovisni o metabolizmu putem CYP2D6, poput flekainida i propafenona (vidjeti dio
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.
Rezultati iz ispitivanja s drugim inhibitorima HIV proteaze i simeprevirom ili daklatazvirom ukazuju na to da će istodobna primjena s fosamprenavirom/ ritonavirom vjerojatno dovesti do povećanja plazmatske izloženosti simepreviru ili daklatazviru zbog inhibicije enzima CYP3A4.
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The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended.
Lijekovi - interakcije Ne preporučuje se istodobna primjena lijeka Telzir s halofantrinom ili (sistemskim) lidokainom.
When ART naïve adult patients were treated with the currently approved doses of fosamprenavir/ritonavir, as for other ritonavir boosted PI regimens, the mutations described were infrequently observed.
U režimima u kojima su odrasli bolesnici, koji ranije nisu primali antiretrovirusnu terapiju, bili liječeni odobrenim dozama fosamprenavira/ritonavira, kao i u drugim IP režimima , opisane mutacije nisu bile često opažene.
Close the bottle tightly with the cap.
11. Zatvaračem čvrsto zatvorite bocu.
Desipramine Nortriptyline
Dezipramin Nortriptilin
Phenotypic resistance testing
Testiranje fenotipske rezistencije
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR TABLETS
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI ZA TABLETE
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).
Medijan trajanja prethodne izloženosti inhibitorima proteaze bio je 149 tjedana za bolesnike koji su primali fosamprenavir s ritonavirom 2 puta dnevno (49 % primilo je ≥2 prethodna IP) i 130 tjedana za bolesnike koji su primali lopinavir/ritonavir (40 % primilo je ≥2 prethodna IP).
This value is decreased by approximately 40 % when Telzir is co-administered with ritonavir, most likely due to an increase in amprenavir bioavailability.
Pri istodobnoj primjeni lijeka Telzir i ritonavira ta se vrijednost smanjuje za oko 40%, najvjerojatnije zbog povećanja bioraspoloživosti amprenavira.
Concomitant use of Telzir with simvastatin or lovastatin is contraindicated because of increased plasma concentrations of lovastatin and simvastatin which can increase the risk of myopathy, including rhabdomyolysis (see section 4.5).
Istodobna primjena lijeka Telzir sa simvastatinom ili lovastatinom kontraindicirana je zbog njihove povećane koncentracije u plazmi što može povećati rizik od miopatije, uključujući rabdomiolizu
Anticonvulsants (carbamazepine, phenobarbital) should be used with caution.
Potreban je oprez pri primjeni antikonvulziva (karbamazepina, fenobarbitala).
Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients listed in section
Preosjetljivost na fosamprenavir, amprenavir, ritonavir ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Don't take other medicines for the infection without your doctor's advice.
Bez savjeta svog liječnika nemojte uzimati druge lijekove za liječenje infekcije.
Cyclosporin Rapamycin Tacrolimus
Ciklosporin Rapamicin Takrolimus
Median Change from baseline in CD4 cells (cells/µl)
Medijan promjene od početnih vrijednosti CD4 stanica (stanica/µl)
Atazanavir: Cmax ↓ 24%* Atazanavir: AUC↓ 22%* Atazanavir: Cmin↔* *compared to atazanavir/ ritonavir 300 mg/ 100 mg once daily
Atazanavir: Cmax ↓ 24%* Atazanavir: AUC↓ 22%* Atazanavir: Cmin↔* * u usporedbi s atazanavir/ ritonavir 300 mg / 100 mg jednom dnevno
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.
U usporedbi s ranije ispitivanom odraslom populacijom koja je primala fosamprenavir s ritonavirom u dozama 700 mg/100 mg 2 puta dnevno, podskupina od 5 pedijatrijskih ispitanika u dobi od 6 do 24 mjeseca koji su primali fosamprenavir/ritonavir u dozi od 45/7 mg/kg 2 puta dnevno pokazala je, unatoč oko 5 puta povećanju doza fosamprenavira i ritonavira prema mg/kg, da je u pedijatrijskih ispitanika AUC(0-τ) amprenavira u plazmi oko 48 % niži, Cmax 26 % niži, i Cτ 29 % niži.
Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26
Noretisteron: Cmax ↓38% Noretisteron: AUC ↓34% Noretisteron: Cmin ↓ 26
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SUSPENSION
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI ZA ORALNU SUSPENZIJU
As a precaution, patients should be monitored for withdrawal syndrome.
Kao mjeru opreza, kod bolesnika treba pratiti je li se pojavio sindrom prekida uzimanja droga.
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).
Djeca i adolescenti: profil nuspojava kod djece i adolescenata temelji se na integriranim podacima o sigurnosti iz 2 ispitivanja (podaci nakon 24 tjedna iz ispitivanja APV29005 i podaci nakon 168 tjedana iz ispitivanja APV20003 [završni podaci]) u kojima je 158 ispitanika s HIV-1 infekcijom u dobi od 2 do 18 godina primalo fosamprenavir s ritonavirom uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze (za informacije o primijenjenim doznim režimima za svaku dobnu skupinu vidjeti dio 5.1).
Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy.
Osip/kožne reakcije: tijekom terapije može doći do eritematoznih ili makulopapularnih izbijanja kožnih promjena, sa ili bez pruritusa.
Atorvastatin 10 mg once daily for 4 days
10 mg jednom dnevno tijekom 4 dana
magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172).
• Drugi sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, povidon K30, magnezijev stearat, koloidni bezvodni silicijev dioksid, hipromeloza, titanijev dioksid (E171), gliceroltriacetat, željezov oksid crveni (E172).
In children and adolescents the fosamprenavir oral suspension should be taken with food.
Djeca i adolescenti trebaju oralnu suspenziju fosamprenavira uzeti s obrokom.
In this patient population, the oral suspension should be taken without food and on an empty stomach.
U ovoj skupini bolesnika, oralnu suspenziju treba uzimati bez hrane, na prazan želudac.
Haemophiliac patients: there have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Bolesnici s hemofilijom: kod bolesnika s hemofilijom koji su primali antiretrovirusne inhibitore proteaze prijavljeni su slučajevi povećanja spontanih krvarenja (vidjeti dio 4.4).
Tricyclic antidepressant: ↑ expected
Triciklički antidepresiv: očekuje se ↑
Maraviroc: C12 ↑ 4.74
Maravirok: Cmax↑ 1,52 Maravirok: C12 ↑ 4,74
• If you have haemophilia.
• Bolujete li od hemofilije.
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.
Djeca mogu primati dozu za odrasle od jedne tablete od 700 mg dva puta dnevno (s ritonavirom od 100 mg dva puta dnevno) ako im je tjelesna težina barem 39 kg te ako mogu progutati cijele tablete.
Insert the syringe firmly into the adapter.
4. Čvrsto umetnite štrcaljku u nastavak.
300 mg once daily
300 mg jednom dnevno
>100,000 copies/ml, n (%)
100.000 kopija/ml
Alfuzosin,
RECEPTORA Alfuzosin
• if you are allergic to fosamprenavir, amprenavir or any of the other ingredients of this medicine
• ako ste alergični na fosamprenavir, amprenavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ili na ritonavir.
If this happens to you: →Talk to your doctor immediately.
→Odmah se obratite svom liječniku.
Don't stop unless your doctor advises you to.
Nemojte prestati uzimati Telzir osim ako to nije zatražio Vaš liječnik.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
generalizirana i/ili žarišna infekcija mikobakterijama i upala pluća uzrokovana s Pneumocystis carinii.
• Feeling sick or being sick (nausea or vomiting), pain in the stomach, loose stools
• povećanje razine triglicerida (vrsta masnoća u krvi). mučnina ili povraćanje, bol u trbuhu, meke stolice
fosamprenavir/ritonavir, plasma concentrations of these antineoplastic medications may be increased and could increase the risk of adverse events usually associated with these antineoplastic agents.
može se povećati koncentracija antineoplastika u plazmi, što može povećati rizik od štetnih događaja koje se obično povezuje s tim antineoplasticima.
Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
D-23843 Bad Oldesloe
Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Metabolički parametri: tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
Co-administration of TELZIR/ritonavir with alfuzosin is contraindicated (see section 4.3).
Istodobna primjena lijeka Telzir/ritonavira s alfuzosinom je kontraindicirana (vidjeti dio 4.3).
Pravastatin or fluvastatin are recommended because their metabolism is not dependent on CYP 3A4 and interactions are not expected with protease inhibitors.
Preporučuju se pravastatin ili fluvastatin s obzirom da njihov metabolizam ne ovisi o CYP
ALPHA 1
ANTAGONISTI ALFA-1
The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily.
Preporučena doza je 700 mg fosamprenavira 2 puta dnevno sa 100 mg ritonavira 2 puta dnevno.
amprenavir and raltegravir (especially in fed conditions) may result in virological
Uočeno značajno smanjenje izloženosti i Cmin za oba lijeka, amprenavir i raltegravir (posebice nakon obroka) kod bolesnika može dovesti do neuspješnog virološkog djelovanja.
(Mixed CYP3A4 induction/inhibition, Pgp induction)
(Miješano indukcija/inhibicija CYP3A4, indukcija Pgp)
• injectable midazolam (used to treat anxiety)
• midazolam u injekcijama (koriste se za liječenje tjeskobe)
No FPV/RTV drug interaction studies.
Nije bilo FPV/RTV ispitivanja interakcija lijeka.
Possible ↓ or ↑ of antithrombotic effect.
antitrombotičkog učinka.
Please refer to the relevant product information for these medications (see section 4.5).
Za više informacija potrebno je vidjeti sažetke opisa svojstava lijeka za navedene lijekove (vidjeti dio 4.5).
Children 6 to 11 years of age (n=9) receiving fosamprenavir / ritonavir 18 / 3 mg/kg twice daily had 26 % higher AUC(0-24) and similar Cmax and Cmin values when compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily.
Djeca u dobi od 6 do 11 godina (n=9) koja su primala fosamprenavir / ritonavir u dozi 18/3 mg/kg 2 puta dnevno imala su 26% veću AUC(0-24) te slične vrijednosti Cmax i Cmin onima kod starije populacije koja je primala fosamprenavir / ritonavir u dozama od 700/100 mg 2 puta dnevno.
ANTIARRHYTHMICS
ANTIARITMICI
Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily
Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * u usporedbi s lopinavirom / ritonavirom 400 mg/100 mg 2 puta dnevno