natgillin/translations-raw huggingface dataset:
The combination of rifampicin and CRIXIVAN with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Kombinacija rifampicina in zdravila CRIXIVAN skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte poglavje 4. 3).
Atovaquone
Druga protiinfekcijska zdravila Atovakon
Interaction with indinavir/ ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
Ritonavir inducira glukuronidacijo, zato se pričakuje zmanjšana koncentracija atovakona v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ ritonavir.
Kadar se atovakon uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija eritromicina in itrakonazola v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ ritonavir.
Kadar se eritromicin in itrakonazol uporabljata sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Ketoconazole ANALGESICS
Ketokonazol ANALGETIKI
Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje, da bosta povečala koncentracije ketokonazola v plazmi.
Co- administration of ritonavir and ketoconazole caused an increased incidence of gastrointestinal and hepatic adverse events.
Sočasna uporaba ritonavirja in ketokonazola je povzročila povečano incidenco gastrointestinalnih in jetrnih neželenih učinkov.
Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ ritonavir.
Kadar se ketokonazol uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
A dose reduction of ketoconazole should be considered when co- administered with indinavir/ ritonavir.
Pri sočasnem dajanju z indinavirjem/ ritonavirjem je treba razmisliti o zmanjšanju odmerka ketokonazola.
Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija fentanila v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ ritonavir.
Kadar se fentanil uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Interaction with indinavir/ ritonavir not studied
Medsebojnega delovanja z indinavirjem/ ritonavirjem niso preučevali.
Increased methadone dose may be necessary when
Morda bo treba povečati odmerek metadona, kadar se daje sočasno z
concomitantly administered with indinavir/ ritonavir.
indinavirjem/ ritonavirjem.
Dose adjustment should be considered based on the
O prilagoditvi odmerka je treba razmisliti glede na bolnikov klinični odziv na zdravljenje
Decreases in methadone AUC has been observed with other ritonavir-boosted protease inhibitors.
Pri zaviralcih proteaze, okrepljenih z ritonavirjem, so opazili zmanjšanje AUC
patient’ s clinical response to methadone therapy.
Priporočila o sočasnem dajanju
Morphine
Morfin ANTIARITMIKI
Interaction with indinavir/ ritonavir not studied Morphine levels may be decreased due to induction of glucuronidation by coadministered ritonavir.
Medsebojnega delovanja z indinavirjem/ ritonavirjem niso preučevali.
Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ ritonavir.
Ravni morfina se lahko znižajo zaradi indukcije glukuronidacije, ki jo povzroča sočasno uporabljen ritonavir.
14 Medicinal products by therapeutic areas ANTIARRTHYMICS
Kadar se morfin uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Digoxin 0.4 mg SD Ritonavir 200 mg BID ANTICOAGULANT
Digoksin 0, 4 mg SD Ritonavir 200 mg BID ANTIKOAGULANT
Interaction with indinavir/ ritonavir not studied Digoxin AUC:
AUC digoksina:
Ritonavir may increase digoxin levels due to modification of P-glycoprotein mediated digoxin efflux.
Ritonavir lahko zviša ravni digoksina zaradi spremembe sproščanja digoksina, ki ga povzroča P- glikoprotein.
Careful monitoring of digoxin levels is recommended when digoxin is concomitantly administered with indinavir/ ritonavir.
Kadar se digoksin uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje ravni digoksina.
Warfarin Ritonavir 400 mg BID ANTICONVULSANTS
Varfarin Ritonavir 400 mg BID ANTIKONVULZIVI
Interaction with indinavir/ ritonavir not studied R-warfarin levels may be decreased leading to reduced anticoagulation due to induction of CYP1A2 and CYP2C9 by ritonavir.
Ravni R- varfarina se lahko znižajo, kar povzroči zmanjšano antikoagulacijo zaradi indukcije CYP1A2 in CYP2C9, ki jo povzroča ritonavir.
Anticoagulation parameters should be monitored when warfarin is coadministered with indinavir/ ritonavir.
Kadar se varfarin uporablja sočasno z indinavirjem/ ritonavirjem, je treba spremljati antikoagulacijske parametre.
Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija karbamazepina v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ ritonavir.
Kadar se karbamazepin uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Divalproex, lamotrigine, phenytoin ANTIDEPRESSANTS
Divalproeks, lamotrigin, fenitoin ANTIDEPRESIVI
Interaction with indinavir/ ritonavir not studied Ritonavir induces oxidation by CYP2C9 and glucuronidation and as a result is expected to decrease the plasma concentrations of anticonvulsants.
Ritonavir inducira oksidacijo, ki jo povzroča CYP2C9, in glukuronidacijo, zato se pričakuje zmanjšanje koncentracij antikonvulzivov v plazmi.
Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ ritonavir.
Kadar se ta zdravila uporabljajo sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje ravni v serumu ali terapevtskih učinkov.
Trazodone 50 mg SD Ritonavir 200 mg BID ANTIHISTAMINES
Trazodon 50 mg SD Ritonavir 200 mg BID ANIHISTAMINIKI
Interaction with indinavir/ ritonavir not studied Trazodone AUC:
Medsebojnega delovanja z indinavirjem/ ritonavirjem niso preučevali.
2.4-fold An increase in the incidence in trazodone- related adverse events was noted when coadministered with ritonavir.
2, 4- krat Pri sočasnem dajanju z ritonavirjem so ugotovili povečano incidenco neželenih učinkov, povezanih s trazodonom.
The combination of trazodone with indinavir/ ritonavir should be used with caution, initiating trazodone at the lowest dosage and monitoring for clinical response and tolerability.
Kombinacijo trazodona in indinavirja/ ritonavirja je treba uporabljati previdno, pri čemer je treba terapijo s trazodonom začeti z najmanjšim odmerkom ter spremljati klinični odziv in toleranco.
Fexofenadine
Feksofenadin
Interaction with indinavir/ ritonavir not studied Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when coadministered resulting in increased concentrations of fexofenadine.
Ritonavir lahko ob sočasnem dajanju spremeni izliv feksofenadina, ki ga povzroča P - glikoprotein, kar povzroča povečane koncentracije feksofenadina.
Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ ritonavir.
Kadar se feksofenadin uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Loratidine CALCIUM CHANNEL BLOCKERS
Loratidin
Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Indinavir in ritonavir zavirata CYP3A4, zato
Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ ritonavir.
Kadar se loratidin uporablja sočasno z indinavirjem/ ritonavirjem, se
Dilitazem 120 mg QD (Indinavir/ ritonavir 800/ 100 BID)
BLOKATORJI KALCIJEVIH KANALČKOV Dilitazem 120 mg QD
Dilitazem AUC0-24hr:
AUC0– 24 h dilitazema:
43% Indinavir/ ritonavir AUCs: ↔
43% AUCs indinavirja/ ritonavirja: ↔
Dose modification of calcium channel blockers should be considered when co-
kalcijevih kanalčkov dajejo sočasno z indinavirjem/ ritonavirjem, je
Amlodipine 5 mg QD (Indinavir/ ritonavir 800/ 100 BID)
Amlodipin 5 mg QD (indinavir/ ritonavir 800/ 100 BID) ZAVIRALCI REDUKTAZE HMG CoA IMUNOSUPRESIVNA ZDRAVILA
Amlodipine AUC0-24hr:
AUC0– 24 h amlodipina:
80% Indinavir/ ritonavir AUCs: ↔
80% AUCs indinavirja/ ritonavirja: ↔
administered with indinavir/ ritonavir as it may result in an increased response.
treba razmisliti o spremembi njihovega odmerka, saj lahko povečajo odziv.
15 Medicinal products by Interaction therapeutic areas HMG-CoA REDUCTASE INHIBITORS IMMUNOSUPPRESSIVES
Enaka priporočila kot pri indinavirju, ki ni okrepljen z ritonavirjem (glejte tabelo 1).
Recommendations concerning co-administration Same recommendations as for indinavir without ritonavir boosting (see Table 1).
Ciklosporin A (indinavir/ ritonavir 800/ 100 BID)
Cyclosporine A Following initiation of indinavir/ ritonavir (Indinavir/ ritonavir 800/ 100 800/ 100 BID or lopinavir/ ritonavir 400/ 100 BID) BID, dose reduction of cyclosporine A to 5- 20% of prior dose was needed to maintain cyclosporine A levels within therapeutic range in one study.
Po začetku dajanja indinavirja/ ritonavirja 800/ 100 BID ali lopinavirja/ ritonavirja 400/ 100 BID so morali v eni študiji odmerek ciklosporina A zmanjšati za 5– 20%, da se je raven ciklosporina A vzdrževala v terapevtskem razponu.
PDE5 INHIBITOR
Takrolimus ZAVIRALEC PDE5
Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ ritonavir.
Medsebojnega delovanja z indinavirjem/ ritonavirjem niso preučevali.
Sildenafil, tadalafil Interaction not studied.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija takrolimusa v plazmi.
For sildenafil and tadalafil, same recommendations as for indinavir without ritonavir boosting (see Table 1).
Kadar se takrolimus uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Vardenafil Interaction not studied.
Sildenafil, tadalafil
SEDATIVES/ HYPNOTICS
Medsebojnega delovanja niso preučevali.
Vardenafil dose should not exceed a maximum of 2.5 mg in a 72-hour period when given with a boosted protease inhibitor.
Pri sildenafilu in tadalfilu veljajo enaka priporočila kot pri indinavirju, ki ni okrepljen z ritonavirjem (glejte tabelo 1).
Buspirone Interaction with indinavir/ ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Medsebojnega delovanja niso preučevali.
Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ ritonavir.
Kadar se vardenafil daje skupaj z okrepljenim zaviralcem proteaze, njegov odmerek v 72- ih urah ne sme preseči maksimalnega odmerka 2, 5 mg.
STEROIDS
Buspiron
CRIXIVAN with ritonavir and oral midazolam should not be coadministered (see section 4.3).
Medsebojnega delovanja z indinavirjem/ ritonavirjem niso preučevali.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Indinavir in ritonavir zavirata CYP3A4, zato se pričakuje povečana koncentracija buspirona v plazmi.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ ritonavir.
Kadar se buspiron uporablja sočasno z indinavirjem/ ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
16
16 Zdravila po terapevtskih področjih
For information regarding diet or the effect of food on indinavir absorption (see
Pričakuje se, da kombinirana uporaba pomembno poveča koncentracije midazolama, predvsem kadar se daje peroralno (inhibicija CYP3A4).
section 4.2 and 5.2).
Deksametazon
Use during pregnancy There are no adequate and well-controlled studies in pregnant patients.
Uporaba med nosečnostjo Ustreznih in dobro kontroliranih raziskav na nosečih ženskah ni.
Given that substantially lower antepartum exposures have been observed in a small study of HIV-infected pregnant patients and the limited data in this patient population, indinavir use is not recommended in HIV-infected pregnant patients (see section 5.2).
Glede na to, da so v majhni raziskavi nosečih žensk, okuženih s HIV, opazovali znatno manjšo predporodno izpostavljenost, in glede na omejene podatke pri tej populaciji bolnic, uporabe indinavira pri nosečih ženskah okuženih s HIV, ne priporočamo (glejte poglavje 5. 2).
Hyperbilirubinaemia, reported predominantly as elevated indirect bilirubin, has occurred in 14% of patients during treatment with indinavir.
Hiperbilirubinemija, o kateri so poročali večinoma kot o zvišani koncentraciji indirektnega bilirubina, se je med zdravljenjem z indinavirjem pojavila pri 14% bolnikov.
Because it is unknown whether indinavir will exacerbate physiologic hyperbilirubinaemia in neonates, careful consideration must be given to the use of indinavir in pregnant women at the time of delivery (see section 4.8).
Ker ni znano, če indinavir poslabša fiziološko hiperbilirubinemijo pri novorojenčkih, je treba skrbno pretehtati uporabo indinavirja pri nosečnicah v času poroda (glejte poglavje 4. 8).
Use during lactation It is recommended that HIV− infected women do not breast− feed their infants under any circumstances in order to avoid transmission of HIV.
Uporaba med dojenjem Priporočeno je, naj ženske okužene z virusom HIV nikakor ne dojijo, da bi se izognile prenosu virusa HIV na novorojenčka.
Mothers should be instructed to discontinue breast− feeding during treatment.
Materam je treba naročiti, naj v času zdravljenja prekinejo z dojenjem.
In controlled clinical trials conducted world– wide, indinavir was administered alone or in combination with other antiretroviral agents (zidovudine, didanosine, stavudine, and/ or lamivudine) to approximately 2,000 patients, the majority of whom were adult Caucasian males (15% females).
V kontroliranih kliničnih raziskavah po vsem svetu so uporabljali indinavir sam ali v kombinaciji z drugimi protiretrovirusnimi zdravili (zidovudinom, didanozinom, stavudinom in/ ali lamivudinom) pri približno 2. 000 bolnikih, med katerimi je bila večina moških belcev (15% žensk).
Clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to CRIXIVAN in ≥ 5% of patients treated with CRIXIVAN alone or in combination (n = 309) for 24 weeks are listed below.
Spodaj so našteti klinični neželeni učinki, o katerih so raziskovalci poročali kot o možno, verjetno ali zagotovo povezanih z zdravilom CRIXIVAN pri ≥ 5% bolnikov (n=309), ki so se 24 tednov zdravili z zdravilom CRIXIVAN samim ali v kombinaciji.
Many of these adverse reactions were also identified as common pre– existing or frequently occurring medical conditions in this population.
Za veliko teh neželenih učinkov so ugotovili, da so ali pogosta predobstoječa stanja ali pogosta obolenja tega prebivalstva.
These adverse reactions were: nausea (35.3%), headache (25.2%), diarrhoea (24.6%), asthenia/ fatigue (24.3%), rash (19.1%), taste perversion (19.1%), dry skin (16.2%), abdominal pain (14.6%), vomiting (11.0%), dizziness (10.7%).
Ti neželeni učinki so bili: navzea (35, 3%), glavobol (25, 2%), driska (24, 6%), občutek šibkosti/ utrujenosti (24, 3%), izpuščaj (19, 1%), motnje okušanja (19, 1%), suha koža (16, 2%), bolečine v trebuhu (14, 6%), bruhanje (11, 0%), omotica (10, 7%).
With the exception of dry skin, rash, and taste perversion, the incidence of clinical adverse reactions was similar or higher among patients treated with antiretroviral nucleoside analogue controls than among patients treated with CRIXIVAN alone or in combination.
Z izjemo suhe kože, izpuščaja in motenj okušanja je bila pojavnost vseh teh kliničnih neželenih učinkov pri bolnikih, ki so se zdravili s primerjalnimi protiretrovirusnimi nukleozidnimi analogi, podobna ali višja kot pri bolnikih, ki so se zdravili z zdravilom CRIXIVAN samim ali v kombinaciji.
This overall safety profile remained similar for 107 patients treated with CRIXIVAN alone or in combination for up to 48 weeks.
Ta celotni varnostni profil je ostal enak pri 107- ih bolnikih, ki so se do 48 tednov zdravili z zdravilom CRIXIVAN samim ali v kombinaciji.
Adverse reactions have also been reported during post-marketing experience* as they are derived from spontaneous reports, incidences cannot be determined.
Ker gre za spontano poročane neželene učinke, se pogostosti ne da določiti.
17 The following adverse reactions have been reported during clinical studies and/ or post-marketing use for CRIXIVAN.
Tekom kliničnih študij in/ ali pri uporabi v obdobju trženja so za CRIXIVAN poročali o naslednjih neželenih učinkih.
Very common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000); Very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); pogostost ni znana (se je ne da oceniti na podlagi podatkov, ki so na voljo)
Blood and the lymphatic disorders:
Bolezni krvi in limfatičnega sistema:
Not known*: increased spontaneous bleeding in patients with haemophilia; anemia including acute haemolytic anaemia; thrombocytopenia (see section 4.4).
Pogostost ni znana *: povečanje pojava spontanih krvavitev pri bolnikih s hemofilijo, anemija vključno z akutno hemolitično anemijo, trombocitopenija (glejte poglavje 4. 4).
Not known*: anaphylactoid reactions.
Pogostost ni znana *: anafilaktoidne reakcije
Not known*: new onset diabetes mellitus or hyperglycaemia, or exacerbation of pre-existing diabetes mellitus (see section 4.4).
Pogostost ni znana *: pojav diabetes mellitusa ali hiperglikemije ali poslabšanje že obstoječega diabetes mellitusa (glejte poglavje 4. 4).
Very common: headache, dizziness Common: insomnia; hypoaesthesia; paraesthesia Not known*: oral paraesthesia.
Pogostost ni znana *: oralna parestezija.
Gastrointestinal disorders:
18 Bolezni prebavil:
Very common: nausea; vomiting; diarrhoea; dyspepsia Common: flatulence; dry mouth; acid regurgitation Not known*: hepatitis, including reports of hepatic failure; pancreatitis.
Pogostost ni znana *: hepatitis, vključno s poročili o jetrni odpovedi, pankreatitis.
Skin and subcutaneous tissue disorders:
Zelo pogosti: izpuščaj, suha koža.
Very common: rash, dry skin Common: pruritus Not known*: rash including erythema multiforme and Stevens Johnson syndrome; hypersensitivity vasculitis; alopecia, hyperpigmentation; urticaria; ingrown toenails and/ or paronychia
Pogostost ni znana *: izpuščaj, vključno z multiformnim eritemom in Stevens- Johnsonovim sindromom, preobčutljivost, vaskulitis, alopecija, hiperpigmentacija, urtikarija, vraščeni nohti na nožnih prstih in/ ali paronihija.
Musculoskeletal, connective tissue and bone disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Common: myalgia Not known*: myositis; rhabdomyolysis
Pogostost ni znana *: miozitis, rabdomioliza.
Very common: nephrolithiasis in paediatric patients 3 years of age and older.
Zelo pogosti: ledvični kamni pri pediatričnih bolnikih, starih 3 leta ali več.
Common: nephrolithiasis in adults; dysuria.
Pogosti: ledvični kamni pri odraslih, disurija.
Nephrolithiasis, including flank pain with or without haematuria (including microscopic haematuria), has been reported in approximately 10% (252/ 2,577) of patients receiving CRIXIVAN in clinical trials at the recommended dose compared to 2.2% in the control arms.
O ledvičnih kamnih, vključno z bolečino v ledvenem predelu in s hematurijo (vključno z mikrohematurijo) ali brez nje, so poročali pri približno 10% bolnikov (252/ 2577), ki so v kliničnih raziskavah prejemali CRIXIVAN v priporočenih odmerkih, v primerjavi z 2, 2% bolnikov iz kontrolne skupine.
In general, these events were not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e. g., 1– 3 days).
Izboljšanje so dosegli z zadostno preskrbo s tekočino in začasno prekinitvijo zdravljenja (npr. za 1- 3 dni).
In clinical trials in paediatric patients 3 years of age and older, the adverse experience profile was similar to that for adult patients except for a higher frequency of nephrolithiasis of 29% (20/ 70) in paediatric patients who were treated with CRIXIVAN at the recommended dose of 500 mg/ m2 every 8 hours.
V kliničnih raziskavah pri pediatričnih bolnikih, starih 3 leta ali več, je bil profil neželenih učinkov podoben kot pri odraslih bolnikih, z izjemo večje pogostnosti ledvičnih kamnov pri pediatričnih bolnikih (29% (20/ 70)), ki so se zdravili z zdravilom CRIXIVAN v priporočenih odmerkih 500 mg/ m2 vsakih 8 ur.
Not known*: nephrolithiasis, in some cases with renal insufficiency or acute renal failure; pyelonephritis; interstitial nephritis, sometimes associated with indinavir crystal deposits.
Pogostost ni znana *: ledvični kamni, v nekaterih primerih z ledvično okvaro ali akutno ledvično odpovedjo, pielonefritis, intersticijski nefritis, včasih povezan z nalaganjem kristalov indinavirja.
In some patients, resolution of the interstitial nephritis did not occur following discontinuation of indinavir therapy; renal insufficiency; renal failure; leucocyturia (see section 4.4).
Pri nekaterih bolnikih se intersticijski nefritis po prenehanju zdravljenja z indinavirjem ni popravil; ledvična okvara; odpoved ledvic; levkociturija (glejte poglavje 4. 4).
18 General disorders and administration site conditions:
Splošne težave in spremembe na mestu aplikacije:
Very common: asthenia/ fatigue; taste perversion; abdominal pain.
Zelo pogosti: utrujenost/ šibkost, motnje okušanja, bolečine v trebuhu.
Not known*:
Pogostost ni znana *:
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 fat and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Kombinirano protiretrovirusno zdravljenje so pri bolnikih s HIV povezali s prerazporeditvijo telesnega maščevja (lipodistrofijo), vključno z izgubo perifernega in obraznega podkožnega maščevja, povečanjem maščevja v trebuhu in visceralnega maščevja, hipertrofijo prsi in kopičenjem maščevja v dorzocervikalnem predelu (bivolja grba).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano protiretrovirusno zdravljenje so povezali s pojavom presnovnih motenj kot so hipertrigliceridemija, hiperholesterolemija, odpornost na insulin, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).