natgillin/translations-raw huggingface dataset:
Appropriate doses of HIV-protease inhibitors in combination with Kaletra with respect to safety and efficacy have not been established.
Koncentraciji lopinavirja in ritonavirja se lahko po prekinitvi šentjanževke zvečata.
Therefore, the concomitant administration of Kaletra with PIs requires close monitoring.
Potrebna utegne biti prilagoditev odmerka zdravila Kaletra.
Amprenavir: see recommendations described for Kaletra tablets co-administration with efavirenz.
Sočasna uporaba zdravila Kaletra lahko močno zviša koncentracijo tega benzodiazepina.
Fosamprenavir: co-administration of standard doses of lopinavir/ ritonavir with fosamprenavir results in a significant reduction in amprenavir concentrations.
Fenotipizacijska koktajl- študija pri 14 zdravih prostovoljcih je pokazala približno 13- kratno povečanje AUC ob peroralni uporabi midazolama in približno 4- kratno povečanje AUC ob uporabi parenteralnega midazolama.
Co-administration of increased doses of fosamprenavir 1400 mg twice daily with lopinavir/ ritonavir 533/ 133 mg twice daily to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ ritonavir.
Če zdravilo Kaletra uporabite sočasno s parenteralnim midazolamom, morate to napraviti v enoti za intenzivno nego (EIN) ali podobnem okolju, ki omogoča natančno klinično spremljanje in ustrezno medicinsko ukrepanje v primeru depresije dihanja in/ ali dolgotrajne sedacije.
Therefore, concomitant administration of these medicinal products is not recommended.
V poštev pride prilagoditev odmerjanja midazolama, zlasti če je uporabljen več kot en sam odmerek midazolama.
Indinavir: indinavir 600 mg twice daily in combination with Kaletra produces similar indinavir AUC, higher Cmin (by 3.5-fold) and lower Cmax relative to indinavir 800 mg three times daily alone.
Večje učinke lahko pričakujemo pri uporabi inhalacijskih oblik flutikazonpropionata.
Furthermore, concentrations of lopinavir do not appear to be affected when both medicinal products, Kaletra and indinivir, are combined, based on historical comparison with Kaletra alone.
Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s
Nelfinavir: see recommendations described for Kaletra tablets co-administration with efavirenz.
75 Cushingovim sindromom in z zaviralnim vplivom na nadledvičo žlezo.
Saquinavir: saquinavir 800 mg twice daily co-administered with Kaletra produces an increase of saquinavir AUC by 9.6-fold relative to saquinavir 1200 mg three times daily given alone.
Omenjeni sistemski kortikosteroidni učinki se lahko pojavijo tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo s P450 3A, npr. budezonid, zato sočasne uporabe zdravila Kaletra in tovrstnih glukokortikodov ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4. 4).
69 Saquinavir 800 mg twice daily co-administered with Kaletra resulted in an increase of saquinavir AUC by approximately 30% relative to saquinavir/ ritonavir 1000/ 100 mg twice daily, and produces similar exposure to those reported after saquinavir/ ritonavir 400/ 400 mg twice daily.
Razmisliti je treba o zmanjšanju odmerka glukokortikoidov ob sočasnem skrbnem nadziranju lokalnih in sistemskih učinkov ali o zamenjavi z glukokortikoidom, ki ni substrat za CYP3A4 (npr. beklometazon).
When saquinavir 1200 mg twice daily was combined with Kaletra, no further increase of concentrations was noted.
V primeru ukinitve kortikosteroida bo odmerek morda treba postopno zmanjševati daljši čas.
Furthermore, concentrations of lopinavir do not appear to be affected when both medicinal products, Kaletra and saquinavir, are combined, based on historical comparison with Kaletra alone.
Učinki visoke sistemske izpostavljenosti flutikazonu na vrednosti ritonavirja v plazmi trenutno še niso znani.
Kaletra co-administered with an additional 100 mg ritonavir twice daily resulted in an increase of lopinavir AUC and Cmin of 33% and 64%, respectively, as compared to Kaletra alone.
Na podlagi znanih presnovnih značilnosti ni pričakovati klinično pomembnega medsebojnega delovanja zdravila Kaletra in fluvastatina, dapsona, trimetoprima/ sulfametoksazola, azitromicina ali flukonazola.
Other medicinal products:
4. 6 Nosečnost in dojenje
Acid reducing agents (omeprazole, ranitidine): in a study performed in healthy volunteers, no clinically relevant interaction has been observed when Kaletra tablets 400/ 100 mg twice daily was co-administered with omeprazole or with ranitidine.
Možno tveganje za ljudi ni znano.
Kaletra can be co-administered with acid reducing agents with no dose adjustment.
Zdravila Kaletra ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Antiarrhythmics:
Študije pri podganah so pokazale, da se lopinavir izloča v mleku.
(bepridil, systemic lidocaine and quinidine): concentrations may be increased when co-administered with Kaletra.
Ni znano, ali se to zdravilo izloča v materinem mleku tudi pri ljudeh.
Caution is warranted and therapeutic concentration monitoring is recommended when available.
S HIV okužene ženske nikakor ne smejo dojiti, da ne pride do prenosa HIV na otroka.
Anticancer agents (eg vincristine, vinblastine): these agents may have their serum concentrations increased when co-administered with lopinavir/ ritonavir resulting in the potential for increased adverse events usually associated with these anticancer agents.
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Anticoagulants: warfarin concentrations may be affected when co-administered with Kaletra.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
It is recommended that INR (international normalised ratio) be monitored.
Bolnikom morate povedati, da so poročali o navzeji med zdravljenjem z zdravilom Kaletra (glejte poglavje 4. 8).
Anticonvulsants (phenobarbital, phenytoin, carbamazepine): will induce CYP3A4 and may decrease lopinavir concentrations.
4. 8 Neželeni učinki
In addition, co-administration of phenytoin and lopinavir/ ritonavir resulted in moderate decreases in steady-state phenytoin concentrations.
Varnost zdravila Kaletra so raziskali pri 612 bolnikih v kliničnih preskušanjih II. in III. faze; 442 teh bolnikov je dobivalo odmerek 400/ 100 mg dvakrat na dan.
Phenytoin levels should be monitored when co-administering with lopinavir/ ritonavir.
V nekaterih študijah so zdravilo Kaletra uporabili v kombinaciji z efavirenzem ali nevirapinom.
Bupropion: in healthy volunteers, the AUC and Cmax of bupropion and of its active metabolite, hydroxybupropion, were decreased by about 50% when co-administered with lopinavir/ ritonavir capsules 400/ 100 mg twice daily at steady-state.
Najpogostejši neželen učinek, povezan z zdravljenjem z zdravilom Kaletra, je bila driska, ki je bila praviloma blaga do zmerna.
This effect may be due to induction of bupropion metabolism.
Med 48- tedenskim obdobjem sta bila deleža prekinitve zaradi neželenih učinkov 4, 5% (naivni bolniki) oz.
Therefore, if the co-administration of lopinavir/ ritonavir with bupropion is judged unavoidable, this should be done under close clinical monitoring for bupropion efficacy, without exceeding the recommended dosage, despite the observed induction.
9% (izkušeni bolniki).
Trazodone: in a pharmacokinetic study performed in healthy volunteers, concomitant use of low dose ritonavir (200 mg twice daily) with a single dose of trazodone led to an increase in plasma concentrations of trazodone (AUC increased by 2.4 fold).
Omeniti je treba, da so opisani primeri pankreatitisa pri bolnikih, ki so dobivali zdravilo Kaletra, vključno s tistimi, pri katerih se je razvila hipertrigliceridemija.
Adverse events of nausea, dizziness, hypotension and syncope were observed following co-administration of trazodone and ritonavir in this study.
Poleg tega so med zdravljenjem z zdravilom Kaletra opisani redki primeri podaljšanja intervala PR (glejte poglavje 4. 4: odstavka o pankreatitisu in zvišanju lipidov).
The combination should be used with caution and a lower dose of trazodone should be considered.
Med uporabo zaviralcev proteaz so, zlasti v kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze, poročali o zvišanju CPK, mialgiji, miozitisu in, redko, rabdomiolizi.
Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of co-administration of Kaletra and digoxin.
Pri bolnikih, okuženih s HIV, je bilo kombinirano protiretrovirusno zdravljenje povezano s prerazporeditvijo telesnega maščevja (lipodistrofijo), vključno z izgubo podkožnega maščevja periferno in na obrazu, zvečanjem intraabdominalnega in visceralnega maščevja, hipertrofijo prsi in dorzocervikalnim kopičenjem maščevja (bivolja grba).
Particular caution should be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on Pgp is
Kombinirano protiretrovirusno zdravljenje je bilo povezano s presnovnimi nepravilnostmi, npr. hipertrigliceridemijo, hiperholesterolemijo, odpornostjo proti insulinu, hiperglikemijo in hiperlaktatemijo (glejte poglavje 4. 4).
Initiation of digoxin in patients already taking Kaletra is expected to result in lower increase of digoxin concentrations.
76 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
Dihydropyridine calcium channel blockers:
Odrasli bolniki
Lipid lowering agents:
Neželeni učinki:
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Kaletra is not recommended.
Opisani so bili naslednji zmerni do hudi neželeni dogodki, ki so morda ali verjetno povezani z zdravilom Kaletra.
Atorvastatin is less dependent on CYP3A for metabolism.
Neželeni učinki so navedeni po organskih sistemih.
When atorvastatin was given concurrently with Kaletra, a mean 4.7-fold and 5.9-fold increase in atorvastatin Cmax and AUC, respectively, was observed.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti: zelo pogosto ≥ 1/ 10, pogosto ≥ 1/ 100, < 1/ 10, občasno ≥ 1/ 1000, < 1/ 100.
When used with Kaletra, the lowest possible dose of atorvastatin should be administered.
Neželeni učinki v kliničnih študijah pri odraslih bolnikih
Rosuvastatin is not dependent on CYP3A.
Infekcijske in parazitske bolezni
However, when given concurrently with Kaletra a mean 5-fold and 2-fold increase in rosuvastatin Cmax and AUC, respectively, was observed.
vnetje srednjega ušesa, bronhitis, sinuzitis, furunkuloza, bakterijska okužba, virusna okužba
The metabolism of pravastatin and fluvastatin is not dependent on CYP3A4, and interactions are not expected with Kaletra.
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi)
If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
benigna neoplazma kože, cista
Dexamethasone: may induce CYP3A4 and may decrease lopinavir concentrations.
Bolezni krvi in limfatičnega sistema
Co-administration of vardenafil with rtionavir containing regimens including Kaletra is expected to result in 49-fold increase in vardenafil AUC.
anemija, levkopenija in limfadenopatija
The use of vardenafil with Kaletra is contraindicated (see section 4.3).
Bolezni endokrinega sistema
Cyclosporin, sirolimus (rapamycin) and tacrolimus: concentrations may be increased when co-administered with Kaletra.
moški hipogonadizem, Cushingov sindrom, hipotiroidizem
High doses of ketoconazole and itraconazole (> 200 mg/ day) are not recommended.
Presnovne in prehranske motnje
Voriconazole: due to the potential for reduced voriconazole concentrations, co-administration of voriconazole and low dose ritonavir (100 mg twice daily) as contained in Kaletra should be avoided unless an assessment of the benefit/ risk to patient justifies the use of voriconazole.
občasno
For patients with renal or hepatic impairment dose reduction of clarithromycin should be considered (see section 4.4).
avitaminoza, dehidracija, edemi, zvečan apetit, laktacidoza, debelost, anoreksija, diabetes mellitus, hiperglikemija, hipoholesteremija
Kaletra can be co-administered with buprenorphine with no dose adjustment.
Psihiatrične motnje
Methadone:
nespečnost
71 Contraceptives: levels of ethinyl oestradiol were decreased when oestrogen-based oral contraceptives were co-administered with Kaletra.
občasno
Rifabutin: when rifabutin and Kaletra were co-administered for 10 days, rifabutin (parent substance and active 25-O-desacetyl metabolite) Cmax and AUC were increased by 3.5- and 5.7-fold, respectively.
nenormalne sanje, agitiranost, anksioznost, zmedenost, depresija, diskinezija, čustvena labilnost, zmanjšan libido, živčnost, nenormalno mišljenje
On the basis of these data, a rifabutin dose reduction of 75% (i. e.
glavobol, parastezija
150 mg every other day or 3 times per week) is recommended when administered with Kaletra.
omotica, amnezija, ataksija, encefalopatija, paraliza obraza, hipertonija, nevropatija, periferni nevritis, zaspanost, tremor, izguba okusa, motnje okusa, migrena, ekstrapiramidni sindrom
Further reduction may be necessary.
Očesne bolezni
However, such a dose adjustment might be associated with ALT/ AST elevations and with increase in gastrointestinal disorders.
nenormalen vid, očesne bolezni
Therefore, this co-administration should be avoided unless judged strictly necessary.
Ušesne bolezni, vključno z motnjami labirinta
If this co-administration is judged unavoidable, increased dose of Kaletra at 400 mg/ 400 mg twice daily may be administered with rifampicin under close safety and therapeutic drug monitoring.
občasno
This is due to the induction of drug metabolising enzymes by St John’ s wort.
tinitus palpitacije, pljučni edem, miokardni infarkt1
Herbal preparations containing St John’ s wort should therefore not be combined with lopinavir and ritonavir.
hipertenzija, tromboflebitis, vaskulitis, varikozne vene, globoka flebotromboza, žilna motnja
If a patient is already taking St John’ s wort, stop St John’ s wort and if possible check viral levels.
Bolezni dihal, prsnega koša in mediastinalnega prostora
Lopinavir and ritonavir levels may increase on stopping St John’ s wort.
dispneja, rinitis, povečan kašelj
The dose of Kaletra may need adjusting.
Bolezni prebavil
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s wort (see section 4.3).
pogosto
Therefore, Kaletra should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Kaletra and parenteral midazolam.
navzeja, bruhanje, bolečine v trebuhu, nenormalno blato, dispepsija, flatulenca, prebavne motnje
If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/ or prolonged sedation.
zvečanje trebuha, zaprtje, suha usta, disfagija, enterokolitis, spahovanje, ezofagitis, fekalna inkontinenca, gastritis, gastroenteritis, hemoragični kolitis, razjede v ustih, pankreatitis2, sialadenitis, stomatitis, ulcerativni stomatitis, periodontitis
Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Bolezni jeter, žolčnika in žolčevodov
The effects of high fluticasone systemic exposure on ritonavir plasma levels is yet unknown.
občasno
72 Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and fluvastatin, dapsone, trimethoprim/ sulfamethoxazole, azithromycin or fluconazole.
holecistitis, hepatitis, hepatomegalija, maščobni jetrni depoziti, občutljivost jeter
4.6 Pregnancy and lactation
Bolezni kože in podkožja
There are no data from the use of Kaletra in pregnant women.
izpuščaj, lipodistrofija, akne
Kaletra should not be used during pregnancy unless clearly necessary.
alopecija, suha koža, ekcem, eksfoliacijski dermatitis, makulopapularen izpuščaj, nepravilnosti nohtov, srbenje, diseboreja, sprememba barve kože, razjeda na koži, edem obraza, znojenje, kožne strije
Studies in rats revealed that lopinavir is excreted in the milk.
Bolezni mišično- skeletnega sistema in vezivnega tkiva
4.7 Effects on ability to drive and use machines
občasno
No studies on the effects on the ability to drive and use machines have been performed.
artralgije, artroza, mialgije, bolečine v hrbtu, sklepna bolezen
4.8 Undesirable effects
Bolezni sečil
The safety of Kaletra has been investigated in 612 patients in Phase II/ III clinical trials, of which 442 have received a dose of 400/ 100 mg twice daily.
ledvični kamni, nenormalnosti urina, albuminurija, hiperkalciurija, nefritis, hiperurikemija
In some studies, Kaletra was used in combination with efavirenz or nevirapine.
Motnje reprodukcije in dojk
The most common adverse reaction associated with Kaletra therapy was diarrhoea and was generally of mild to moderate severity.
občasno
It is important to note that cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
nenormalna ejakulacija, amenoreja, zvečanje prsi, ginekomastija, impotenca, menoragija
Furthermore, rare increases in PR interval have been reported during Kaletra therapy (see section 4.4: sections pancreatitis and lipid elevations).
Splošne težave in spremembe na mestu aplikacije
Increased CPK, myalgia, myositis, and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
pogosto
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
astenija, bolečine
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
občasno
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
bolečine v prsih, bolečine v prsih substernalno, mrzlica, zvišana telesna temperatura, gripozni sindrom, splošno slabo počutje, periferni edemi, interakcije z zdravili
Adult patients
78 Preiskave
Adverse reactions:
zelo pogosto (3. ali 4. stopnje)
The following adverse reactions of moderate to severe intensity with possible or probable relationship to Kaletra have been reported.
zvišani trigliceridi, zvišan celokupni holesterol, zvišana GGT
The adverse reactions are displayed by system organ class.
pogosto (3. ali 4. stopnje)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common > 1/ 10, common > 1/ 100 ,< 1/10, uncommon > 1/ 1000, < 1/ 100.
zvišana glukoza, zvišana amilaza, zvišana SGOT/ AST, zvišana SGPT/ ALT, nenormalni jetrni funkcijski testi
73 Undesirable effects in clinical studies in adult patients Infections and infestations
2
Otitis media, bronchitis, sinusitis, furunculosis, bacterial infection, viral infection
zmanjšana toleranca za glukozo, zvečanje telesne mase, hujšanje, zvišan bilirubin, spremenjen hormonski nivo, nenormalen lab. test
Neoplasms benign, malignant and unspecified (including cysts and polyps)
glejte poglavje 4. 4: pankreatitis in
Uncommon
lipidi.
Skin benign neoplasm, cyst
Pediatrični bolniki
Blood and lymphatic system disorders
Infekcijske in parazitske bolezni
Uncommon
pogosto
Anaemia, leucopenia and lymphadenopathy
virusne okužbe
Hypogonadism male, Cushing syndrome, hypothyroidism
motnje okusa
Metabolic and nutritional disorders
Bolezni prebavil
Avitaminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes mellitus, hyperglycaemia, hypocholesteremia
zaprtje, bruhanje, pankreatitis *
Psychiatric disorders
Bolezni jeter, žolčnika in žolčevodov
Insomnia
hepatomegalija
Abnormal dreams, agitation, anxiety, confusion, depression, dyskinesia, emotional lability, decreased libido, nervousness, abnormal thinking
izpuščaj, suha koža
Headache, paresthesia
zvišana telesna temperatura
Uncommon
Preiskave
Dizziness, amnesia, ataxia, encephalopathy, facial paralysis, hypertonia, neuropathy, peripheral neuritis, somnolence, tremor, taste loss, taste perversion, migraine, extrapyramidal syndrome
zvišan aktivirani parcialni tromboplastinski čas, znižan hemoglobin, zmanjšano število trombocitov, zvišan natrij, zvišan kalij, zvišan kalcij, zvišan bilirubin, zvišana SGPT/ ALT, zvišana SGOT/ AST, zvišan celokupni holesterol, zvišana amilaza, zvišana sečna kislina, znižan natrij, znižan kalij, znižan kalcij, zmanjšano število nevtrofilcev
Eye disorders Ear and labyrinth disorders Cardiac disorders Vascular disorders
* Glejte poglavje 4. 4: pankreatitis in lipidi.
Uncommon Uncommon Uncommon Uncommon
Pomarketinške izkušnje
Abnormal vision, eye disorder Tinnitus Palpitation, lung oedema, myocardial infarct1 Hypertension, thrombophlebitis, vasculitis, varicose vein, deep thrombophlebitis, vascular disorder
Pri bolnikih, ki so dobivali zdravilo Kaletra v prisotnosti ali odsotnosti prepoznavnih dejavnikov tveganja za hepatitis, sta bila opisana hepatitis in, redko, zlatenica.
Respiratory, thoracic and mediastinal disorders
Poročali so o Stevens- Johnsonovemu sindromu in multiformnemu eritemu.
Uncommon
Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
Dyspnoea, rhinitis, cough increased
Pogostnost tega ni znana (glejte poglavje 4. 4).
Gastrointestinal disorders
79 4. 9 Preveliko odmerjanje
Very common
Izkušnje z akutnim prevelikim odmerjanjem zdravila Kaletra pri ljudeh so doslej omejene.
Diarrhoea
Med neželenimi kliničnimi znaki pri psih so bili slinjenje, emeza in driska oz. nenormalno blato.
Nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder
Med znaki toksičnosti pri miših, podganah ali psih so bili zmanjšana aktivnost, ataksija, huda shujšanost, dehidracija in tremor.
Uncommon
Za preveliko odmerjanje zdravila Kaletra ni specifičnega antidota.
Abdomen enlarged, constipation, dry mouth, dysphagia, enterocolitis, eructation, oesophagitis, faecal incontinence, gastritis, gastroenteritis, haemorrhagic colitis, mouth ulcerations, pancreatitis2, sialadenitis, stomatitis, ulcerative stomatitis, periodontitis
Če je indicirano, je odstranitev neabsorbirane zdravilne učinkovine mogoče doseči z bruhanjem ali izpiranjem želodca.
Hepatobiliary disorders
FARMAKOLOŠKE LASTNOSTI
Uncommon
5. 1 Farmakodinamične lastnosti
Cholecystitis, hepatitis, hepatomegaly, liver fatty deposit, liver tenderness
Farmakoterapevtska skupina: zaviralci proteaz, oznaka ATC:
Common
J05AE06
Rash, lipodystrophy, acne
Zavrtje proteaze HIV prepreči razcep poliproteina gag- pol, tako da nastane nezrel, neinfektivni virus.
Uncommon
Učinki na elektrokardiogram:
Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, nail disorder, pruritis, seborrhoea, skin discoloration, skin ulcer, face oedema, sweating, skin striae
Povprečna sprememba dolžine intervala PR v primerjavi z izhodiščem je bila med 12- urnim obdobjem po odmerku od 11, 6 ms do 24, 4 ms.
74 Musculoskeletal and connective tissue disorders
Najdaljši interval PR je bil 286 msec, primerov srčnega bloka druge ali tretje stopnje pa ni bilo (glejte poglavje 4. 4).
Uncommon
102 nM.