natgillin/translations-raw huggingface dataset:
Clinical data on fertility are not available for tipranavir.
Nisu dostupni klinički podaci o tipranaviru s obzirom na plodnost.
Taking Aptivus with etravirine is not recommended.
Ne preporučuje se uzimanje Aptivusa s etravirinom.
Ethinyl oestradiol Cmax ↓ 52% Ethinyl oestradiol AUC ↓ 43% Mechanism unknown Norethindrone Cmax ↔ Norethindrone AUC ↑ 27% Tipranavir ↔
Etinilestradiol Cmax ↓ 52% Etinilestradiol AUC ↓ 43% Mehanizam nepoznat Noretindron Cmax ↔ Noretindron AUC ↑ 27% Tipranavir ↔
Virological response to tipranavir with ritonavir therapy has been evaluated using a tipranavirassociated mutation score based on baseline genotype in RESIST-1 and RESIST-2 patients.
Virološka reakcija na tipranavir s ritonavirom ocijenjena je i u odnosu na „mutacijski skor“ temeljen na početnoj genotipizaciji bolesnika uključenih u RESIST-1 i RESIST-2.
After baseline and placebo adjustment, the maximum mean QTcF change was 3.2 ms (1-sided 95% Upper CI: 5.6 ms) for the 500/200 mg dose and 8.3 ms (1-sided 95% Upper CI: 10.8 ms) for the supra-therapeutic 750/200 mg dose.
Uz korekciju za bazalne vrijednosti i vrijednosti nakon izlaganja placebu, maksimalna prosječna QTcF promjena iznosila je 3,2 ms (gornja granica 95% CI: 5,6 ms) za dozu od 500/200 mg, te 8,3 ms (gornja granica 95% CI: 10,8 ms) za supraterapijsku dozu od 750/200 mg.
The baseline characteristics and the key efficacy results at 48 weeks for the paediatric patients receiving Aptivus capsules are displayed in the tables below.
Početna svojstva i ključni rezultati djelotvornosti tijekom 48 tjedana za djecu liječenu Aptivus kapsulama prikazani su tablično u nastavku teksta.
Aptivus 100 mg/ml oral solution tipranavir
Aptivus 100 mg/ml oralna otopina tipranavir
Increased ALAT/ASAT monitoring should be considered in these patients.
Potrebno je razmotriti pojačano praćenje vrijednosti ALT/AST u spomenutih bolesnika.
If indicated, elimination of unabsorbed tipranavir should be achieved by emesis or gastric lavage.
Ako je indicirano, potrebno je eliminirati neapsorbirani tipranavir indukcijom povraćanja ili ispiranjem želuca.
The mechanism of action is thought to be induction of glucuronosyltransferase by tipranavir/r.
Smatra se da je mehanizam interakcije indukcija glukuronoziltransferaze djelovanjem tipranavira/r.
It blocks an enzyme called protease that is involved in the reproduction of HIV.
Inhibira enzim koji se naziva proteaza, a koji je uključen u umnožavanje HIV-a.
First-dose tipranavir/r:
Prva doza tipranavira/r:
Other HMG-CoA reductase inhibitors should be considered such as pravastatin, fluvastatin or rosuvastatin (see section 4.5).
Potrebno je razmotriti primjenu drugih inhibitora HMG-CoA reduktaze, kao što su pravastatin, fluvastatin, ili rosuvastatin (vidjeti dio 4.5).
Protease inhibitors (PIs)
Inhibitori proteaze (IP)
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Uz oportunističke infekcije, nakon početka uzimanja lijeka za liječenje infekcije HIV-om također može doći i do autoimunih poremećaja (stanje koje se javlja kada imunološki sustav napada zdravo tkivo u tijelu).
No dosing adjustment is required in patients with mild hepatic impairment but patients should be closely monitored (see sections 4.2 and
Nije potrebno podešavanje doza za bolesnike s blagim oštećenjem jetre, ali se bolesnici moraju pažljivo pratiti (vidjeti dijelove 4.2 i 4.4).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg tipranavir.
KVALITATIVNI I KVANTITAVNI SASTAV Jedan ml oralne otopine sadrži 100 mg tipranavira.
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Sistemski učinci kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju prijavljeni su u bolesnika na ritonaviru i na inhalacijskom ili intranazalnom flutikazonpropionatu, što se također može pojaviti uz druge kortikosteroide koji se metaboliziraju putem P450 3A, npr. budezonid.
Amongst the most common adverse reactions reported for Aptivus were gastrointestinal complaints such as diarrhoea and nausea as well as hyperlipidaemia.
Među najčešće prijavljenim nuspojavama za Aptivus su gastrointestinalne tegobe, kao što su proljev i mučnina, te hiperlipidemija.
C-tipranavir human study (500 mg
tipranavirom u ljudi (500 mg
Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
Bolesnici s umjerenim ili teškim (Child-Pugh B ili C) oštećenjem jetre.
Blood and lymphatic system disorders uncommon neutropenia, anaemia, thrombocytopenia
Poremećaji krvi i limfnog sustava manje često neutropenija, anemija, trombocitopenija
s r.o.
S.C.S.
Most frequently reported moderate or severe adverse reactions in paediatric patients aged 12 to 18 years who took Aptivus capsules (reported in 2 or more children, Trial 1182.14, week 48 analyses, Full Analysis Set).
Najčešće prijavljene umjerene ili teške nuspojave u pedijatrijskoj populaciji starosti 12-18 godina liječene Aptivus kapsulama (prijavljeno za 2 ili više djece, ispitivanje 1182.14, analiza 48 tjedana, svi ispitanici).
If you use oral contraceptives or HRT you have an increased chance of developing a skin rash while taking Aptivus.
Ako primjenjujete oralne kontraceptive ili HNT, pod povećanim ste rizikom od razvoja osipa na koži tijekom primjene Aptivusa.
If another cause is identified (e.g. acute hepatitis A, B or C virus, gallbladder disease, other medicinal products), then rechallenge with Aptivus may be considered when ASAT/ALAT have returned to the patient's baseline levels.
Ako se prepozna drugi uzrok (npr. akutni hepatitis A, B ili C, bolest žučnog mjehura, drugi lijekovi), ponovno uvođenje Aptivusa se može razmatrati kada se vrijednosti AST/ALT vrate na početne vrijednosti (prije započinjanja liječenja).
Nevirapine No interaction study performed
Nevirapin Ne postoje studije interakcija
You should talk to your doctor as you may need to temporarily stop taking either Aptivus or your oral contraceptives or HRT - carbamazepine, phenobarbital and phenytoin (used to treat epilepsy).
Potrebno je posavjetovati se s liječnikom jer ćete možda trebati privremeno prekinuti s primjenom ili Aptivusa ili oralnih kontraceptiva ili HNT-a - karbamazepin, fenobarbital i fenitoin (primjenjuju se u liječenju epilepsije).
Co-administration of Aptivus with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Istodobna primjena Aptivusa i niske doze ritonavira s djelatnim tvarima čiji klirens izrazito ovisi o CYP3A, a čije su povišene koncentracije u plazmi povezane s teškim i/ili po život opasnim događajima.
If your child misses a dose of Aptivus and/or ritonavir by less than 5 hours, give the missed dose immediately.
Ako Vaše dijete propusti dozu Aptivusa i/ili ritonavira za manje od 5 sati, neka odmah uzme propuštenu dozu.
Crystals may be seen as a paper-thin layer at the bottom of the bottle when it is stored upright.
Kristali se smiju vidjeti u tankom sloju na dnu boce u izokrenutom položaju.
SQV/rtv FAS PP
SQV/rtv Svi ispitanici PP
If you forget to take Aptivus
Ako ste zaboravili uzeti Aptivus
Tipranavir pharmacokinetics have not been studied in patients with renal impairment.
Farmakokinetika tipranavira nije ispitivana u bolesnika s oštećenjem bubrega.
Omeprazole and other proton pump inhibitors
Omeprazol i drugi inhibitori protonske pumpe
A cocktail study was conducted in 16 healthy volunteers with twice-daily tipranavir 500 mg with ritonavir 200 mg capsule administration for 10 days to assess the net effect on the activity of hepatic CYP 1A2 (caffeine), 2C9 (warfarin), 2D6 (dextromethorphan), both intestinal/hepatic CYP 3A4 (midazolam) and P-glycoprotein (P-gp) (digoxin).
U ispitivanju na 16 zdravih dobrovoljaca, 500 mg tipranavira s 200 mg ritonavira u obliku kapsula primjenjivano je dvaput dnevno tijekom 10 dana radi ocjene neto-učinka na aktivnost jetrenog CYP 1A2 (kofein), 2C9 (varfarin), 2D6 (dekstrometorfan) i intestinalnog/hepatičkog CYP 3A4 (midazolam) i P-glikoproteina (P-gp) (digoksin).
Alternative or additional contraceptive measures are to be used when oestrogen based oral contraceptives are coadministered with Aptivus and low dose ritonavir.
Potrebno je primijeniti alternativne ili dodatne kontracepcijske mjere kad se oralni kontraceptivi na bazi estrogena primjenjuju istodobno s Aptivusom i niskom dozom ritonavira.
The unbound fraction of tipranavir appeared to be independent of total concentration over this concentration range.
U tom rasponu koncentracija, nevezana frakcija neovisna je o ukupnoj koncentraciji.
- tiredness - jaundice (yellowing of the skin or the eyeballs)
- abdominalna bol - umor - žutica (žutilo kože ili bjeloočnica)
Valaciclovir and Aptivus with low dose of ritonavir may be coadministered without dose adjustment.
Valaciklovir i Aptivus s niskom dozom ritonavira se mogu istodobno primjenjivati bez podešavanja doze.
A higher increase of blood lipids were seen with tipranavir/ritonavir than with comparators (other protease inhibitors) in clinical trials.
U kliničkim ispitivanjima veći porast lipida u krvi je primijećen kod liječenja sa tipranavirom/ritonavirom, nego kod liječenja s komparatorima (drugim inhibitorima proteaze).
This study was also conducted with Aptivus oral solution 500 mg with ritonavir 200 mg and showed the same CYP P450 and P-gp interactions as the Aptivus capsule 500 mg with ritonavir 200 mg. Based on the results from this study, Aptivus oral solution might be expected to have a similar interaction profile as the capsules.
Ispitivanje je provedeno i s Aptivus oralnom otopinom 500 mg uz ritonavir 200 mg, te je pokazalo istovjetne CYP P450 i P-gp-interakcije kao za Aptivus kapsule
Patients should be monitored for opiate withdrawal syndrome.
Potrebno je pratiti bolesnike radi sindroma opijatne apstinencije.
Tadalafil 10 mg QD Tadalafil first-dose Cmax ↓ 22% Tadalafil first-dose AUC ↑ 133%
Tadalafil 10 mg QD Tadalafil, prva doza Cmax ↓ 22% Tadalafil, prva doza AUC ↑ 133%
Didanosine Cmax ↓ 43% Didanosine AUC ↓ 33%
Didanozin Cmax ↓ 43% Didanozin AUC ↓ 33%
A causal relationship has been evoked, although the mechanism of action had not been elucidated.
Smatra se da postoji uzročno-posljedični odnos između Aptivusa i krvarenja, iako mehanizam djelovanja nije objašnjen.
Renal impairment No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Nije potrebno podešavanje doze u bolesnika s oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
Proton pump inhibitors (PPIs) Omeprazole 40 mg QD Omeprazole Cmax ↓ 73% Omeprazole AUC ↓ 70%
Inhibitori protonske pumpe (IPP) Omeprazol 40 mg QD Omeprazol Cmax ↓ 73% Omeprazol AUC ↓ 70%
In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving Aptivus with ritonavir.
U in vitro eksperimentima, primijećeno je da tipranavir inhibira agregaciju ljudskih trombocita pri koncentracijama koje odgovaraju koncentracijama u plazmi koje se postižu prilikom liječenja Aptivusom s ritonavirom.
- digoxin (used to treat heart arrhythmias and heart failure) - antifungal medications including fluconazole, itraconazole, ketoconazole or voriconazole
- lijekovi za liječenje gljivičnih infekcija uključujući flukonazol, itrakonazol, ketokonazol ili vorikonazol
When co-administered, tipranavir and cobicistat exposures are markedly lower compared to that of tipranavir when boosted with low dose ritonavir.
Kada se istodobno primjenjuju, izloženosti tipranaviru i kobicistatu su značajno manje u usporedbi s izloženošću tipranaviru koji je pojačan niskom dozom ritonavira.
Moreover, in patients with a body surface area of less than 1.33 m² appropriate dose adjustments cannot be achieved with the capsule formulation.
Osim toga, u bolesnika s tjelesnom površinom manjom od 133 m² kapsulama nije moguće postići odgovarajuće doziranje.
Combined 48-week median time to treatment failure for both studies was 115 days in the tipranavir with ritonavir arm and 0 days in the comparator arm (no treatment response was imputed to day 0).
Na temelju 48-tjednih podataka iz obje studije, medijan vremena do pojave neuspjeha liječenja iznosio je 115 dana za ispitivanu skupinu, te 0 dana za kontrolnu skupinu (nisu imputirani podaci za terapijski odgovor 0. dana).
CYP 3A4 inhibition by tipranavir/r and P-gp (an intestinal efflux transporter) inhibition by clarithromycin.
CYP 3A4 inhibicija putem tipranavira/r i P-gp (crijevni efluksni prijenosnik) inhibicija klaritromicinom.
The dose for children, aged 2 to 12 years, will be calculated by the doctor.
Dozu za dijete u dobi 2 do 12 godina izračunava liječnik temeljem djetetove tjelesne površine u kvadratnim metrima.
First-dose tipranavir/r Midazolam Cmax ↑ 5.0 fold Midazolam AUC ↑ 27 fold
Prva doza tipranavira/r Midazolam Cmax ↑ 5,0 puta Midazolam AUC ↑ 27 puta
The baseline characteristics and the key efficacy results at 48 weeks for the paediatric patients receiving Aptivus oral solution are displayed in the tables below.
Početna svojstva i ključni rezultati o djelotvornosti tijekom 48 tjedana za djecu liječenu Aptivus oralnom otopinom prikazani su tablično u nastavku teksta.
Tipranavir is contraindicated in moderate or severe hepatic impairment (see sections 4.2 and 4.3).
Tipranavir je kontraindiciran u umjerenom ili teškom oštećenju jetre (vidjeti dijelove 4.2 i 4.3).
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors.
Aptivus, uz istodobnu primjenu niske doze ritonavira, indiciran je u kombiniranom antiretrovirusnom liječenju infekcije virusom HIV-1 u djece od 2 do 12 godina starosti koja su prethodno liječena višestrukim antiretrovirusnim lijekovima, a u kojih je virus otporan na veći broj inhibitora proteaze.
Patients receiving rifabutin with Aptivus, co-administered with low dose ritonavir, should be closely monitored for emergence of adverse events associated with rifabutin therapy.
Bolesnici koji primaju rifabutin s Aptivusom uz nisku dozu ritonavira moraju se pomno pratiti radi nuspojava rifabutina.
There is a heterogeneous effect of telaprevir on ritonavir-boosted protease inhibitor drug plasma levels, depending on the protease inhibitors.
Učinak telaprevira na koncentracije ritonavirom pojačanog inhibitora proteaze u plazmi je heterogen, ovisno o inhibitorima proteaze.
Etravirine Cmax ↓ 71% Etravirine AUC ↓ 76% Etravirine Cmin ↓ 82%
Etravirin Cmax ↓ 71% Etravirin AUC ↓ 76% Etravirin Cmin ↓ 82%
Tipranavir, co-administered with low dose ritonavir, increases the plasma concentrations of atorvastatin (see section 4.5).
Tipranavir s niskom dozom ritonavira povećava koncentracije atorvastatina u plazmi (vidjeti dio 4.5).
In in vitro studies, tipranavir was found to inhibit platelet aggregation when using human platelets (see section 4.4) and thromboxane A2 binding in an in vitro cell model at levels consistent with exposure observed in patients receiving Aptivus with ritonavir.
In-vitro, tipranavir inhibira agregaciju ljudskih trombocita (vidjeti dio 4.4) i vezanje tromboksana A2 u koncentracijama koje odgovaraju koncentracijama koje se postižu u bolesnika koji primaju Aptivus s ritonavirom.
Open the bottle by pressing down on the cap and turning in an anti-clockwise direction.
Otvorite bocu pritiskom na zatvarač i okretanjem u smjeru suprotnom od smjera kazaljke na satu.
What Aptivus looks like and contents of the pack Aptivus soft capsules are pink coloured, oblong soft gelatin capsules with a black print imprint of ‘TPV 250'.
Aptivus meke kapsule su ružičaste, duguljaste meke kapsule od želatine s crno otisnutom oznakom ‘TPV 250'.
Relationships between baseline phenotypic susceptibility to tipranavir, primary PI mutations, protease mutations at codons 33, 82, 84 and 90, tipranavir resistance-associated mutations, and response to tipranavir with ritonavir therapy were assessed.
Ocijenjen je odnos rezultata liječenja tipranavirom s ritonavirom i početne fenotipske osjetljivosti na tipranavir, primarne IP mutacije, mutacije proteaze u kodonima 33, 82, 84 i 90 i mutacije povezane s rezistencijom na tipranavir.
You should talk to your child's doctor as they may need to temporarily stop taking either Aptivus or their oral contraceptives or HRT - carbamazepine, phenobarbital and phenytoin (used to treat epilepsy).
Potrebno je posavjetovati se s djetetovim liječnikom jer će dijete možda trebati privremeno prekinuti s primjenom ili Aptivusa ili oralnih kontraceptiva ili HNT-a - karbamazepin, fenobarbital i fenitoin (primjenjuju se u liječenju epilepsije).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 250 mg tipranavir.
KVALITATIVNI I KVANTITAVNI SASTAV Jedna meka kapsula sadrži 250 mg tipranavira.
Steady-state tipranavir/r: S-warfarin Cmax ↓ 17% S-warfarin AUC ↓ 12%
Tipranavir/r pri stanju ravnoteže: S-varfarin Cmax ↓ 17% S-varfarin AUC ↓ 12%
In patients with normal renal and hepatic function, a reduction in colchicine dosage or an interruption of colchicine treatment is recommended in co-administration (see section 4.5).
Kada se primjenjuje istodobno u bolesnika s urednom funkcijom bubrega i jetre, preporučuje se snižavanje doze kolhicina ili prekid liječenja kolhicinom (vidjeti dio 4.5).
Therefore patients should not be switched from Aptivus capsules to Aptivus oral solution (see sections 5.1 and 5.2).
Stoga se bolesnicima terapija Aptivus kapsulama ne bi trebala zamjenjivati u terapiju Aptivus oralnom otopinom (vidjeti dijelove 5.1 i 5.2).
Purified water ‘Sorbitol special-glycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) Titanium dioxide (E171)
Ovojnica kapsule želatina željezov oksid, crveni (E172) propilenglikol pročišćena voda mješavina posebnog sorbitola i glicerina (d-sorbitol, 1,4 sorbitan, manitol i glicerin) titanijev dioksid (E171)
Pharmacokinetic enhancer Cobicistat and cobicistatcontaining products
Farmakokinetički pojačivač Kobicistat i lijekovi koji sadrže kobicistat
Fluconazole ↔ Tipranavir Cmax ↑ 32% Tipranavir AUC ↑ 50% Tipranavir Cmin ↑ 69% Mechanism unknown
Flukonazol ↔ Tipranavir Cmax ↑ 32% Tipranavir AUC ↑ 50% Tipranavir Cmin ↑ 69% Mehanizam nepoznat
Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (see sections 4.3, 4.4 and 5.2).
Aptivus je kontraindiciran u bolesnika s umjerenim ili teškim (Child-Pugh stupanj B ili C) oštećenjem jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
3); median baseline plasma HIV-1 RNA was 4.79 and 4.80 log10 copies/ml, respectively (ranges 2.34-6.52 and 2.01-6.76 log10 copies/ml).
3 (raspon 1-1184); medijan početnog broja virusnih kopija HIV-1 RNA u plazmi u ispitivanoj skupini iznosio je 4,79 log10/ml a u kontrolnoj 4,80 log10/ml (raspon 2,34-6,52 i 2,0-6,76 log10 kopija/ml).
Boceprevir exposure was reduced when co-administered with ritonavir-boosted lopinavir or ritonavir-boosted darunavir.
Izloženost bocepreviru bila je smanjena kod istodobne primjene s ritonavirom pojačanim lopinavirom ili ritonavirom pojačanim darunavirom.
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.
Aptivus je, uz istodobnu primjenu niske doze ritonavira, indiciran za kombinirano antiretrovirusno liječenje infekcije virusom HIV-1 u odraslih i adolescenata u dobi od 12 i više godina starosti koji su prethodno liječeni višestrukim antiretrovirusnim lijekovima, a u kojih je virus otporan na veći broj inhibitora proteaze.
A 5 ml oral syringe and adapter is supplied for dosing.
Priložena je oralna štrcaljka od 5 ml i nastavak.
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child. - Keep this leaflet.
Vaše dijete počne uzimati ovaj lijek jer sadrži važne podatke u vezi Vašeg djeteta.
You should inform your child's doctor as soon as possible if you notice your child has the signs or symptoms of hepatitis: - fever - malaise (feeling generally unwell) - nausea (upset stomach) - vomiting - abdominal pain
Potrebno je obavijestiti djetetovog liječnika što je prije moguće ako primijetite znakove ili simptome hepatitisa: - vrućica - malaksalost (opći osjećaj lošeg stanja) - mučnina - povraćanje
Mild to moderate rashes including urticarial rash, maculopapular rash, and photosensitivity have been reported in subjects receiving Aptivus, co-administered with low dose ritonavir.
Blagi do umjereni osipi, uključujući urtikarijski osip, makulopapularni osip i foto-senzibilnost, prijavljeni su u bolesnika liječenih Aptivusom s niskom dozom ritonavira.
Antifungals
Antifungici
Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products.
Aptivus se uvijek mora dati uz nisku dozu ritonavira (farmakokinetički pojačivač), te u kombinaciji s drugim antiretrovirusnim lijekovima.
Studies with co-administration of tipranavir and ritonavir did not reveal any additional toxicological effects when compared to those seen in the tipranavir single agent toxicological studies.
Ispitivanja istodobne primjene tipranavira i ritonavira nisu otkrila dodatne toksikološke učinke, u usporedbi s monoterapijom tipranavirom.
Therefore, it is recommended that patients switching from Aptivus oral solution to capsules at the age of 12 years are closely monitored for the virologic response of their antiretroviral regimen (see sections 5.1 and 5.2).
Stoga se preporuča pažljivo praćenje virološkog odgovora u bolesnika koji prelaze s Aptivus oralne otopine na kapsule u dobi od 12 godina (vidjeti dijelove 5.1 i 5.2).
There was an average decrease in susceptibility of 2-fold wild type (WT) for tipranavir, 12-fold WT for amprenavir, 55-fold WT for atazanavir, 41-fold WT for indinavir, 87-fold WT for lopinavir, 41fold WT for nelfinavir, 195-fold WT for ritonavir, and 20-fold WT for saquinavir.
Tijekom studija osjetljivost na tipranavir smanjila se prosječno dvostruko (u odnosu na osjetljivost divljeg tipa virusa), na amprenavir 12 puta, na atazanavir 55 puta, na indinavir 41 put, na lopinavir 87 puta, na nelfinavir 41 puta, na ritonavir 195 puta i na sakvinavir 20 puta.
Rare: may affect up to 1 in 1,000 people - Liver failure (including fatal outcome) - Hepatitis - Fatty liver - Increased blood levels of bilirubin (a breakdown product of haemoglobin) - Dehydration (when the body does not have enough water) - Thinning of the face - Bleeding in the brain* (see above) - Increased blood levels of the pancreas enzyme lipase
Rijetko: mogu se javiti u do 1 na 1000 osoba - zatajenje jetre (uključujući fatalan ishod) - hepatitis - masna jetra - povišene vrijednosti bilirubina u krvi (razgradni produkt hemoglobina) - dehidracija (kada vaše tijelo nema dovoljno vode) - stanjivanje lica - krvarenje u mozgu* (vidjeti gore) - povišene vrijednosti lipaze, enzima gušterače, u krvi
The concomitant use of Aptivus, co-administered with low dose ritonavir, with simvastatin or lovastatin are contra-indicated due to an increased risk of myopathy, including rhabdomyolysis (see section 4.3).
Istodobna primjena Aptivusa s niskom dozom ritonavira i simvastatina ili lovastatina je kontraindicirana zbog povećanog rizika od miopatije, uključujući rabdomiolizu (vidjeti dio 4.3).