natgillin/translations-raw huggingface dataset:
24 In an open label trial completed in 1998 in HIV infected, clinically stable children there was a significant difference (p = 0.03) in the detectable RNA levels in favour of a triple regimen (ritonavir, zidovudine and lamivudine) following 48 weeks treatment.
24 V odprtem preskušanju, dokončanem leta 1998, s HIV okuženih, klinično stabilnih otrok, so po 48 tednih zdravljenja ugotovili pomembno razliko (p = 0, 03) v zaznavni koncentraciji RNA v prid trojne sheme (ritonavir, zidovudin in lamivudin).
In a study completed in 2003, 50 HIV-1 infected, protease inhibitor and lamivudine naïve children age 4 weeks to 2 years received ritonavir 350 or 450 mg/m2 every 12 hours co-administered with zidovudine 160 mg/m2 every 8 hours and lamivudine 4 mg/kg every 12 hours.
V študiji, dokončani leta 2003, je 50 otrok, starih od 4 tedne do 2 leti, ki so bili okuženi s HIV- 1 in še niso dobivali zaviralcev proteaz in lamivudina, dobivalo ritonavir 350 ali 450 mg/ m2 na 12 ur sočasno z zidovudinom 160 mg/ m2 na 8 ur in lamivudinom 4 mg/ kg na 12 ur.
In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of ≤ 400 copies/ml at Week 16 and 104, respectively.
V analizah z namenom zdravljenja je po 16 tednih 72% preiskovancev doseglo znižanje plazemskih RNA HIV- 1 na ≤ 400 kopij/ ml, po 104 tednih pa 36% preiskovancev.
Upon multiple dosing, ritonavir accumulation is slightly less than predicted from a single dose due to a time and dose-related increase in apparent clearance (Cl/F).
Po večkratnem odmerjanju je kopičenje ritonavirja rahlo večje, kot bi predvidevali na podlagi enkratnega odmerka, in sicer zaradi časa ter z odmerkom povezanega zvečanja navideznega očistka (Oč/ F).
Renal clearance averaged less than 0.1 l/h and was relatively constant throughout the dosage range.
Ledvični očistek je bil v povprečju manj kot 0, 1 l/ uro in je bil v vsem odmernem območju razmeroma stalen.
mg once daily
100 mg 100 mg
100 mg twice 200 mg once daily1 daily
200 mg 200 mg
Cmax (µg/ml)
enkrat na dan
0.84 ± 0.39
dvakrat na dan
0.89
Cmax (μg/ ml)
3.4 ± 1.3
0, 84 ± 0, 39
4.5 ± 1.3
3, 4 ± 1, 3 4, 5 ± 1, 3 0, 89
Ctrough (µg/ml)
Cmin d. r.
0.08 ± 0.04
(μg/ ml)
0.16 ± 0.10
0, 08 ± 0, 04
0.6 ± 0.2
0, 16 ± 0, 10 0, 6 ± 0, 2 0, 22
AUC12 or 24 (µg•h/ml)
AUC12 ali 24 (μg• uro/ ml)
t½ (h)
t1/ 2 (ure)
Cl/F (L/h) 1
Oč/ F (l/ uro) 1
Values expressed as geometric means.
Vrednosti so izražene kot geometrične sredine.
Ingestion of ritonavir with food results in higher ritonavir exposure than ingestion in the fasted state.
Zaužitje ritonavirja s hrano povzroči večjo izpostavljenost ritonavirju kot zaužitje na tešče.
The apparent volume of distribution (VB/F) of ritonavir is approximately 20 - 40 l after a single 600 mg dose.
Navidezni volumen porazdelitve (VB/ F) ritonavirja je po enem samem 600 mg odmerku približno 20 - 40 l.
The protein binding of ritonavir in human plasma is approximately 98 - 99% and is constant over the concentration range of 1.0 – 100 μg /ml.
Vezava ritonavirja na beljakovine v človeški plazmi je približno 98- 99% in je v koncentracijskem območju od 1, 0 do 100 μg/ ml stalna.
Ritonavir binds to both human alpha 1-acid glycoprotein (AAG) and human serum albumin (HSA) with comparable affinities.
Ritonavir se veže na humani alfa- 1- kisli glikoprotein (AAG) in na humani serumski albumin (HSA) s primerljivima afinitetama.
Tissue distribution studies with 14C-labelled ritonavir in rats showed the liver, adrenals, pancreas, kidneys and thyroid to have the highest concentrations of ritonavir.
Raziskave porazdelitve v tkivih s 14C- označenim ritonavirjem pri podganah so pokazale najvišje koncentracije ritonavirja v jetrih, nadledvičnih žlezah, trebušni slinavki, ledvicah in ščitnici.
Ritonavir was noted to be extensively metabolised by the hepatic cytochrome P450 system, primarily by the CYP3A isozyme family and to a lesser extent by the CYP2D6 isoform.
25 Ugotovljeno je, da se ritonavir izdatno presnavlja s sistemom jetrnega citokroma P450, predvsem z družino izoencimov CYP3A in v manjši meri z izoobliko CYP2D6.
The isopropylthiazole 25 oxidation metabolite (M-2) is the major metabolite and has antiviral activity similar to that of parent drug.
Glavni presnovek je izopropiltiazolski oksidacijski presnovek (M- 2); njegova protivirusna aktivnost je podobna protivirusni aktivnosti matičnega zdravila.
However, the AUC of the M-2 metabolite was approximately 3% of the AUC of parent drug.
Vendar je AUC presnovka M- 2 le približno 3% AUC matičnega zdravila.
Low doses of ritonavir have shown profound effects on the pharmacokinetics of other protease inhibitors (and other products metabolised by CYP3A4) and other protease inhibitors may influence the pharmacokinetics of ritonavir (see section 4.5).
Majhni odmerki ritonavirja so pokazali močne učinke na farmakokinetiko drugih zaviralcev proteaz (in drugih zdravil, ki se presnavljajo s CYP3A4), drugi zaviralci proteaz pa lahko vplivajo na farmakokinetiko ritonavirja (glejte poglavje 4. 5).
Human studies with radiolabelled ritonavir demonstrated that the elimination of ritonavir was primarily via the hepatobiliary system; approximately 86% of radiolabel was recovered from stool, part of which is expected to be unabsorbed ritonavir.
Približno 86% izotopa so našli v blatu, del tega gre verjetno na račun neabsorbiranega ritonavirja.
Patients with impaired liver function: after multiple dosing of ritonavir to healthy volunteers (500 mg twice daily) and subjects with mild to moderate hepatic impairment (Child Pugh Class A and B, 400 mg twice daily) exposure to ritonavir after dose normalisation was not significantly different between the two groups.
Po večkratnem odmerjanju ritonavirja pri zdravih prostovoljcih (500 mg dvakrat na dan) in preiskovancih z blago do zmerno okvaro jeter (razreda A in B po Child Pughu, 400 mg dvakrat na dan) se izpostavljenost ritonavirju po normalizaciji odmerka med skupinama ni pomembno razlikovala.
Patients with impaired renal function:
Bolniki z okvarjenim delovanjem ledvic:
Ritonavir steady-state pharmacokinetic parameters were evaluated in HIV infected children above 2 years of age receiving doses ranging from 250 mg/m² twice daily to 400 mg/m² twice daily.
Farmakokinetične parametre ritonavirja v stanju dinamičnega ravnovesja so ocenili pri otrocih, okuženih s HIV, starejših od 2 let, ki so dobivali odmerke od 250 mg/ m2 dvakrat na dan do 400 mg/ m2 dvakrat na dan.
Ritonavir concentrations obtained after 350 to 400 mg/m² twice daily in paediatric patients were comparable to those obtained in adults receiving 600 mg (approximately 330 mg/m²) twice daily.
Koncentracije ritonavirja, dosežene po 350 do 400 mg/ m2 dvakrat na dan, so bile pri otrocih primerljive tistim pri odraslih po odmerku 600 mg (približno 330 mg/ m2) dvakrat na dan.
Across dose groups, ritonavir oral clearance (CL/F/m2) was approximately 1.5 to 1.7 times faster in paediatric patients above 2 years of age than in adult subjects.
Prek vseh odmernih skupin je bil peroralni očistek ritonavirja (Oč/ F/ m2) približno 1, 5 - do 1, 7- krat hitrejši pri pediatričnih bolnikih, starejših od 2 let, kot pri odraslih preiskovancih.
Ritonavir steady-state pharmacokinetic parameters were evaluated in HIV infected children less than 2 years of age receiving doses ranging from 350 to 450 mg/m² twice daily.
Farmakokinetični parametri ritonavirja v stanju dinamičnega ravnovesja so bili ocenjeni pri otrocih, okuženih s HIV, mlajših od 2 let, ki so dobivali odmerke od 350 do 450 mg/ m2 dvakrat na dan.
Ritonavir concentrations in this study were highly variable and somewhat lower than those obtained in adults receiving 600 mg (approximately 330 mg/m²) twice daily.
Koncentracije ritonavirja so bile v tej študiji zelo spremenljive in nekoliko nižje kot pri odraslih, ki so dobivali 600 mg (približno 330 mg/ m2) dvakrat na dan.
Across dose groups, ritonavir oral clearance (CL/F/m2) declined with age with median values of 9.0 L/h/m2 in children less than 3 months of age, 7.8 L/h/m2 in children between 3 and 6 months of age and 4.4 L/h/m2 in children between 6 and 24 months of age.
Mediana vrednost pri otrocih do 3 mesecev starosti je bila 9, 0 l/ uro/ m2, pri otrocih od 3 do 6 mesecev starosti 7, 8 l/ uro/ m2 in pri otrocih od 6 do 24 mesecev starosti 4, 4 l/ uro/ m2.
However, clinical trials revealed no evidence of drug-induced ocular changes in humans.
Klinična preskušanja pri ljudeh niso odkrila z zdravilom izzvanih sprememb na očeh.
Clinical investigation in humans has revealed no clinically significant alteration in thyroid function tests.
Klinične raziskave pri ljudeh niso pokazale klinično pomembnih sprememb v 26 preiskavah delovanja ščitnice.
26 Developmental toxicity observed in rats (embryolethality, decreased foetal body weight and ossification delays and visceral changes, including delayed testicular descent) occurred mainly at a maternally toxic dosage.
Toksični učinki na razvoj, ugotovljeni pri podganah (embrioletalnost, zmanjšana fetalna telesna masa, zapoznela osifikacija in visceralne spremembe, vključno z zapoznelo spustitvijo testisov), so se v glavnem pojavili pri odmerkih, toksičnih za samico- mater.
Developmental toxicity in rabbits (embryolethality, decreased litter size and decreased foetal weights) occurred at a maternally toxic dosage.
Toksični učinki na razvoj pri kuncih (embrioletalnost, manjša velikost legla in zmanjšana fetalna masa) so se pojavili pri odmerkih, toksičnih za samico- mater.
Ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay using S. typhimurium and E. coli, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
Nobeden ni pokazal, da bi bil Ritonavir mutagen ali klastogen.
Norvir oral solution contains: alcohol, purified water, polyoxyl 35 castor oil, propylene glycol, anhydrous citric acid, saccharin sodium, peppermint oil, creamy caramel flavour, sunset yellow E110
Peroralna raztopina Norvir vsebuje: alkohol, prečiščeno vodo, makrogolglicerol ricinolat 35, propilenglikol, brezvodno citronsko kislino natrijev saharinat, eterično olje poprove mete, okus kremne karamele, oranžno barvilo FCF (E110).
Norvir should not be diluted with water.
Norvirja se ne sme redčiti z vodo.
6 months
6 mesecev.
Store below 25°C and use within the expiry date shown on the bottle.
Shranjujte pri temperaturi do 25°C in porabite pred datumom izteka roka uporabnosti, označenem na steklenički.
Norvir oral solution is supplied in amber coloured multiple-dose polyethylene terephthalate (PET) bottles in a 90 ml size.
Peroralna raztopina Norvir je na voljo v večodmernih 90 ml stekleničkah jantarne barve iz polietilentereftalata (PET).
Each pack contains 5 bottles of 90 ml (450 ml).
Vsako pakiranje vsebuje 5 stekleničk po 90 ml (450 ml).
A dosage cup containing graduations at 3.75 ml (300 mg dose), 5 ml (400 mg dose), 6.25 ml (500 mg dose) and 7.5 ml (600 mg dose) is provided.
Priložena je odmerna čaša z oznakami 3, 75 ml (odmerek 300 mg), 5 ml (odmerek 400 mg), 6, 25 ml (odmerek 500 mg) in 7, 5 ml (odmerek 600 mg).
6.6 Special precautions for disposal and other handling
27 6. 6 Posebni varnostni ukrepi za odstranjevanje
The dosage cup or oral syringe should be cleaned immediately with hot water and dish soap after use.
Odmerno čašo ali peroralno brizgo je treba takoj po uporabi očistiti z vročo vodo in milom za posodo.
The device must be dry prior to use
Pripomoček mora biti suh, preden se uporabi.
26 August 1996 Date of last renewal:
26. avgust 1996 Datum podaljšanja dovoljenja za promet:
27 August 2006
27. avgust 2006
Norvir 100 mg soft capsules
Norvir 100 mg mehke kapsule
Each soft capsule contains 100 mg ritonavir.
Ena mehka kapsula vsebuje 100 mg ritonavirja.
Excipients (per soft capsule):
Pomožne snovi (na mehko kapsulo):
Alcohol (12%w/w) Castor Oil Polyoxyl 35
Alkohol (12% m/ m) Makrogolglicerol ricinolat 35
The capsule is white with “Abbott A” and the code “DS100” imprinted on the shell in black ink.
Kapsula je bela in ima na ovojnici s črnim črnilom natisnjeno "Abbott A" in oznako "DS100".
Ritonavir soft capsules are administered orally and should preferably be ingested with food.
Mehke kapsule z ritonavirjem se uporabljajo peroralno, po možnosti s hrano.
As ritonavir is primarily metabolised by the liver, ritonavir may be appropriate for use with caution as a pharmacokinetic enhancer in patients with renal insufficiency depending on the
Ritonavir se presnavlja predvsem v jetrih.
29 specific protease inhibitor with which it is co-administered.
Zato utegne biti potrebna previdnost, če je uporabljen kot farmakokinetični stopnjevalec pri bolnikih z insuficienco ledvic; to je odvisno od 29 specifičnega zaviralca proteaz, s katerim je uporabljen sočasno.
The recommended dosage of Norvir soft capsules is 600 mg (6 capsules) twice daily by mouth.
Priporočeno odmerjanje mehkih kapsul Norvir je 600 mg (6 kapsul) peroralno dvakrat na dan.
Treatment should be initiated at 300 mg (3 capsules) twice daily for a period of three days and increased by 100 mg (1 capsule) twice daily increments up to 600 mg twice daily over a period of no longer than 14 days.
Zdravljenje je treba začeti s 300 mg (3 kapsule) dvakrat na dan v obdobju 3 dni in odmerek zvečevati po 100 mg (1 kapsula) dvakrat na dan do 600 mg dvakrat na dan v obdobju, ki ne presega 14 dni.
Paediatric use (2 years of age and above): the recommended dosage of Norvir in children is 350 mg/m² by mouth twice daily and should not exceed 600 mg twice daily.
Priporočeno odmerjanje Norvirja pri otrocih je 350 mg/ m2 peroralno dvakrat na dan in ne sme preseči 600 mg dvakrat na dan.
Norvir should be started at 250 mg/m² and increased at 2 to 3 day intervals by 50 mg/m² twice daily (please refer to the Norvir 80 mg/ml oral solution Summary of Product Characteristics)
Norvir je treba na začetku uporabljati v odmerku 250 mg/ m2 in ga v presledkih od 2 do 3 dni zvečevati po 50 mg/ m2 dvakrat na dan (glejte povzetek glavnih značilnosti zdravila za Norvir 80 mg/ ml peroralno raztopino).
For older children it may be feasible to substitute soft capsules for the maintenance dose of the oral solution.
Pri starejših otrocih je namesto vzdrževalnega odmerka peroralne raztopine ponavadi mogoče uporabiti mehke kapsule.
Dosage conversion from oral solution to soft capsules for children
Pretvorba odmerkov s peroralne raztopine na mehke kapsule za otroke:
Oral solution dose 175 mg (2.2 ml) twice daily 350 mg (4.4 ml) twice daily 437.5 mg (5.5 ml) twice daily 525 mg (6.6 ml) twice daily
odmerek peroralne raztopine 175 mg (2, 2 ml) dvakrat na dan 350 mg (4, 4 ml) dvakrat na dan 437, 5 mg (5, 5 ml) dvakrat na dan 525 mg (6, 6 ml) dvakrat na dan
Capsule dose 200 mg in the morning and 200 mg in the evening 400 mg in the morning and 300 mg in the evening 500 mg in the morning and 400 mg in the evening 500 mg in the morning and 500 mg in the evening
odmerek kapsul 200 mg zjutraj in 200 mg zvečer 400 mg zjutraj in 300 mg zvečer 500 mg zjutraj in 400 mg zvečer 500 mg zjutraj in 500 mg zvečer
The safety and efficacy of ritonavir in children under the age of 2 have not been established.
Varnost in učinkovitost ritonavirja pri otrocih do 2. leta starosti nista ugotovljeni.
The renal clearance of ritonavir is negligible, therefore, a decrease in the total body clearance is not expected in patients with renal impairment.
Ledvični očistek ritonavirja je zanemarljiv; zato pri bolnikih z okvaro ledvic ni pričakovati zmanjšanja celotnega telesnega očistka.
Pharmacokinetic data indicate that no dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
Farmakokinetični podatki kažejo, da odmerka pri bolnikih z blago do zmerno okvaro jeter po vsem sodeč ni treba prilagajati (glejte poglavje 5. 2).
Ritonavir should not be given to patients with severe hepatic impairment (see section 4.3).
Norvirja ne smejo dobiti bolniki s hudo okvaro jeter (glejte poglavje 4. 3).
30 4.3 Contraindications
4. 3 Kontraindikacije 30 Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Concomitant Drug Levels Increased α1-Adrenoreceptor Antagonist
Zvišanje koncentracije sočasno uporabljenega zdravila Αntagonist adrenergičnih receptorjev α1
Antifungal
Antimikotik
31 Antimycobacterial
31
HMG Co-A Reductase Inhibitor
Zaviralec reduktaze HMGCoA
(For caution on parenterally administered midazolam, see section 4.5.)
(Za previdnost pri uporabi parenteralnega midazolama glejte poglavje 4. 5.)
John’s Wort
Zeliščni pripravki
Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (see section 4.5).
Zeliščni pripravki s šentjanževko (Hypericum perforatum) zaradi tveganja za znižanje plazemske koncentracije in kliničnih učinkov ritonavirja (glejte poglavje 4. 5).
4.4 Special warnings and precautions for use
32 4. 4 Posebna opozorila in previdnostni ukrepi
Patients receiving Ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Bolnikom, ki dobivajo ritonavir ali kakšno drugo protiretrovirusno zdravilo, se lahko še naprej pojavljajo oportunistične okužbe in drugi zapleti okužbe s HIV- 1.
Ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer 32 Patients with chronic diarrhoea or malabsorption:
Ritonavir, odmerjan kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec
Serious persistent vomiting and/or diarrhoea associated with ritonavir use might also compromise renal function.
Hudo, dolgotrajno, z ritonavirjem povezano bruhanje in/ ali driska lahko poleg tega ogrozi delovanje ledvic.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ ali
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
33 žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
33 Renal disease:
Bolezni ledvic:
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART – combination antiretroviral therapy) ali obojim.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per maximum dose of 600 mg.
Mehka kapsula z ritonavirjem vsebuje majhne količine etanola (alkohol), tj. manj kot 100 mg na največji odmerek 600 mg.
The following Warnings and Precautions should be considered when ritonavir is used as a antiretroviral agent.
Če je ritonavir uporabljen kot protiretrovirusno zdravilo, je treba upoštevati naslednja opozorila in previdnostne ukrepe.
PDE5 inhibitors:
Zaviralci fosfodiesteraze tipa 5 (PDE5):
HMG-CoA reductase inhibitors:
Zaviralci reduktaze HMGCoA:
Caution must also be exercised and reduced doses should be considered if ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A.
Previdnost je potrebna tudi pri hkratni uporabi ritonavirja z atorvastatinom, ki se v manjši meri presnavlja s CYP3A; v poštev 34 pride zmanjšanje odmerkov.
In patients who are already taking digoxin when ritonavir is introduced, the digoxin dose should be reduced to one-half of the patients’ normal dose and patients need to be followed more closely than usual for several weeks after initiating co-administration of ritonavir and digoxin.
Bolnikom, ki ob uvedbi ritonavirja že jemljejo digoksin, je treba odmerek zmanjšati na polovico njihovega običajnega odmerka.
34 In patients who are already taking ritonavir when digoxin is introduced, digoxin should be introduced more gradually than usual.
Po začetku sočasne uporabe ritonavirja in digoksina je treba bolnike več tednov kontrolirati pogosteje kot ponavadi.
Concomitant use of ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing’s syndrome and adrenal suppression (see section 4.5).
Sočasna uporaba ritonavirja in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ni priporočljiva, razen če možna korist zdravljenja odtehta tveganje sistemskih učinkov kortikosteroidov, vključno s Cushingovim sindromom in adrenalno supresijo (glejte poglavje 4. 5).
Co-administration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease.
Sočasna uporaba sakinavirja in ritonavirja je povzročila hude neželene učinke, predvsem diabetično ketoacidozo in jetrne motnje, zlasti pri bolnikih z že obstoječo boleznijo jeter.
Saquinavir/ritonavir should not be given together with rifampicin, due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three medicines are given together (see section 4.5).
Sakvinavirja/ ritonavirja ne smete dajati hkrati z rifampicinom: med sočasno uporabo teh treh zdravil namreč obstaja tveganje za hude hepatotoksične učinke (ki se pokažejo z zvišanjem jetrnih transaminaz) (glejte poglavje 4. 5).
35 Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent
Ritonavir, odmerjan kot farmakokinetični stopnjevalec ali kot protiretrovirusno zdravilo
The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (eg digoxin and fexofenadine-see table “Ritonavir effects on non-antiretroviral drugs” below).
Zaviralni učinek ritonavirja (z drugimi zaviralci proteaz ali brez njih) na aktivnost P- gp se lahko sčasoma zmanjša (npr. digoksin in feksofenadin – glejte spodnjo tabelo “ Učinki ritonavirja na neretrovirusna zdravila ”).
Ritonavir may induce glucuronidation and oxidation by CYP1A2, CYP2C8, CYP2C9 and CYP2C19 thereby increasing the biotransformation of some medicinal products metabolised by these pathways, and may result in decreased systemic exposure to such medicinal products, which could decease or shorten their therapeutic effect.
Posledica je lahko manjša sistemska izpostavljenost takšnim zdravilom, kar lahko zmanjša ali skrajša njihov terapevtski učinek.
Serum levels of ritonavir can be reduced by concomitant use of herbal preparations containing St John’s wort (Hypericum perforatum).
Sočasna uporaba zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), lahko zmanjša koncentracijo ritonavirja v serumu, ker šentjanževka inducira encime, ki presnavljajo zdravila.
This is due to the induction of drug metabolising enzymes by St John’s wort.
Zeliščnih pripravkov s šentjanževko se zato ne sme uporabljati v kombinaciji z ritonavirjem.
Herbal preparations containing St John’s wort must not be used in combination with ritonavir.
Če bolnik že jemlje šentjanževko, njeno jemanje prekinite in, če je mogoče, kontrolirajte raven virusov.
If a patient is already taking St John’s wort, stop St John’s wort and if possible check viral levels.
Koncentracija ritonavirja se lahko po prenehanju jemanja šentjanževke zveča.
Ritonavir levels may increase on stopping St John’s wort.
Potrebna utegne biti prilagoditev odmerka ritonavirja.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’s wort (see section 4.3).
Indukcijski učinek lahko traja še vsaj 2 tedna po opustitvi šentjanževke (glejte poglavje 4. 3).
Drugs that are affected by the use of ritonavir
Zdravila, na katera vpliva uporaba ritonavirja
Drug Interactions – Ritonavir with Protease Inhibitors
Medsebojno delovanje zdravil – ritonavir z zaviralci proteaz 36
Drug
uporabljenega zdravila (mg)
(mg) (mg)
NORVIRJA (mg)