natgillin/translations-raw huggingface dataset:
The concomitant use of tadalafil with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer should be with caution at reduced doses of no more than 10 mg tadalafil every 72 hours with increased monitoring for adverse events (see section 4.4).
Med sočasno uporabo tadalafila in ritonavirja, odmerjanega kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, je potrebna previdnost; odmerek tadalafila je treba zmanjšati in ne sme preseči 10 mg na 72 ur.
Vardenafil
Odmerek sočasno
5, single
Odmerek NORVIRJA
600 q12h
Vpliv na AUC sočasno
↑ 49-fold
Vpliv na Cmax sočasno
↑ 13-fold
uporabljenega
17
(mg)
Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
uporabljenega
Dose of NORVIR (mg)
zdravila (mg)
Effect on Co- administered Drug AUC
učinkov (glejte poglavje 4. 4).
Effect on Co- administered Drug Cmax
5, posamičen odmerek
The concomitant use of vardenafil and ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer should be with caution at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring for adverse events (see section 4.4).
Ob tem je potrebno intenzivnejše nadziranje glede neželenih učinkov (glejte poglavje 4. 4).
Sedatives/hynoptics Clorazepate, diazepam, estazolam, flurazepam, oral and parenteral midazolam and triazolam
Sedativi/ hipnotiki Klorazepat, diazepam, estazolam, flurazepam, Sočasna uporaba ritonavirja ponavadi zviša koncentracijo klorazepata, peroralni in parenteralni midazolam in triazolam
Ritonavir co-administration is likely to result in increased plasma concentrations of clorazepate, diazepam, estazolam and flurazepam and is therefore contraindicated (see section 4.3).
diazepama, estazolama in flurazepama v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Co-administration with Norvir may cause a large increase in the concentration of this benzodiazepine.
Sočasna uporaba Norvirja lahko zelo zviša koncentracijo tega benzodiazepina.
No drug interaction study has been performed for the co-administration of Norvir with benzodiazepines.
Študij medsebojnega delovanja glede sočasne uporabe Norvirja in benzodiazepinov ni bilo izvedenih.
Therefore, Norvir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Norvir and parenteral midazolam.
Zato Norvirja ne smete uporabljati sočasno s peroralnim midazolamom (glejte poglavje 4. 3), v primeru sočasne uporabe Norvirja in parenteralnega midazolama pa je potrebna previdnost.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3 – 4 fold increase in midazolam plasma levels.
Podatki o sočasni uporabi parenteralnega midazolama z drugimi zaviralci proteaz nakazujejo možno 3 - do 4- kratno zvišanje koncentracije midazolama v plazmi.
If Norvir 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.
Če Norvir uporabite sočasno s parenteralnim midazolamom, morate to izvesti v enoti za intenzivno nego (EIN) ali podobnem okolju, ki omogoča natančno klinično spremljanje in ustrezno medicinsko ukrepanje v primeru depresije dihanja in/ ali podaljšane sedacije.
0.125 single dose 200, 4 doses ↑ > 20 fold ↑ 87% Ritonavir co-administration is likely to result in increased plasma concentrations of triazolam and is therefore contraindicated (see section 4.3).
0, 125 posamičen 200, 4 odmerki ↑ > 20- krat ↑ 87% odmerek Sočasna uporaba ritonavirja ponavadi zviša koncentracijo triazolama v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
50 oral single dose
50 posamičen 500 na 12 ur peroralni
500 q12h
↓ 62%
↓ 62%
↓ 59%
↓ 59%
Presnovek normeperidina
Normeperidine metabolite
odmerek
The use of meperidine and ritonavir is contraindicated due to the increased concentrations of the metabolite, normeperidine, which has both analgesic and CNS stimulant activity.
Uporaba meperidina in ritonavirja je kontraindicirana zaradi zvišane koncentracije presnovka normeperidina, ki deluje analgetično in stimulira osrednje živčevje.
Elevated normeperidine concentrations may increase the risk of CNS effects (eg, seizures), see section 4.3.
Zvišana koncentracija normeperidina lahko poveča tveganje za učinke na osrednjem živčevju (npr. konvulzivne napade), glejte poglavje 4. 3.
200 q12h, 2 days
200 na 12 ur, 2 ↑ 2, 5- krat dni 500 na 12 ur, ↓ 12% 10 dni
↔
↔ ↓ 16%
After ritonavir use for 10 days, no inhibitory effect of ritonavir was observed.
Po 10- dnevni uporabi ritonavirja niso opazili nobenega zaviralnega učinka ritonavirja.
18 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
18 Učinki ritonavirja na sočasno uporabljena neretrovirusna zdravila Sočasno uporabljeno zdravilo
Sleeping agent Zolpidem
Uspavalo Zolpidem
↑ 28%
200, 4 odmerki ↑ 28%
100 mg q12h 600 mg q12h
100 mg na 12 ur
↓ 21% ↓ 62%
600 mg na 12 ur ↓ 66%
Steroids Fluticasone propionate aqueous nasal spray
Steroidi Flutikazonijev propionat, vodno pršilo za nos 200 µg na dan 100 na 12 ur
↑ ~350-fold
↑ ~350- krat
↑ ~ 25-fold
↑ ~ 25- krat
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression (plasma cortisol levels were noted to be decreased 86% in the above study) have been reported in patients receiving ritonavir and inhaled or intranasal fluticasone propionate; similar effects could also occur with other corticosteroids metabolised by CYP3A eg, budesonide.
Podobni učinki bi se lahko pojavili tudi pri drugih kortikosteroidih, ki jih presnavlja CYP3A, npr. pri budezonidu.
Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Zato sočasna uporaba ritonavirja, odmerjanegakot protiretrovirusno zdravilo ali kot farmakokinetični stopnjevalec, in teh glukokortikoidov ni priporočljiva, razen če možna korist terapije odtehta tveganja sistemskih učinkov kortikosteroidov (glejte poglavje 4. 4).
A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (eg, beclomethasone).
V poštev pride zmanjšanje glukokortikoida, ob čemer je treba natančno kontrolirati lokalne in sistemske učinke, ali pa prehod na glukokortikoid, ki ni substrat CYP3A4 (npr. beklometazon).
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of dexamethasone.
Zato je treba pričakovati, da zviša koncentracijo deksametazona v plazmi.
20 200 q12h ↑ 28% ↑ 9%
20 200 na 12 ur ↑ 28% ↑ 9% Med sočasno uporabo prednizolona in ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov.
19 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
Učinki ritonavirja na sočasno uporabljena neretrovirusna zdravila Sočasno uporabljeno zdravilo
Careful monitoring of therapeutic and adverse effects is recommended when prednisolone is concomitantly administered with ritonavir.
uporabljenega
ND:
(mg)
Not determined 1.
ND: ni določeno 1.
Based on a parallel group comparison 2.
Na podlagi primerjave vzporednih skupin 2.
Cardiac and neurologic events have been reported when ritonavir has been co-administered with disopyramide, mexiletine or nefazadone.
Med sočasno uporabo ritonavirja z dizopiramidom, meksiletinom ali nefazodonom so bili opisani kardiološki in nevrološki učinki.
The possibility of drug interaction cannot be excluded.
Možnosti za medsebojno delovanje zdravil ni mogoče izključiti.
In addition to the interactions listed above, as ritonavir is highly protein bound, the possibility of increased therapeutic and toxic effects due to protein binding displacement of concomitant medications should be considered.
Zato je poleg zgoraj naštetih interakcij treba upoštevati možnost večjih terapevtskih in toksičnih učinkov zaradi izpodrinjenja sočasno uporabljenih zdravil z vezave na beljakovine.
Important information regarding drug interactions when ritonavir is used a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the co-administered protease inhibitor.
Pomembne informacije o medsebojnem delovanju zdravil med uporabo ritonavirja kot farmakokinetičnega stopnjevalca vsebuje tudi povzetek glavnih značilnosti sočasno uporabljenega zaviralca proteaz.
Proton pump inhibitors and H2-receptor antagonists: proton pump inhibitors and H2-receptor antagonists (e.g. omeprazole or ranitidine) may reduce concentrations for co-administered protease inhibitors.
Zaviralci protonske črpalke in antagonisti receptorjev H2: zaviralci protonske črpalke in antagonisti receptorjev H2 (npr. omeprazol ali ranitidin) lahko zmanjšajo koncentracijo sočasno uporabljenih zaviralcev proteaz.
For specific information regarding the impact of co-administration of acid reducing agents, refer to the SmPC of the co-administered protease inhibitor.
Za specifične informacije o vplivu sočasne uporabe zdravil, ki zmanjšujejo kislino, glejte povzetek glavnih značilnosti hkrati uporabljanega zaviralca proteaz.
Based on interaction studies with the ritonavir boosted protease inhibitors (lopinavir/ritonavir, atazanavir), concurrent administration of omeprazole or ranitidine does not significantly modify ritonavir efficacy as a pharmacokinetic enhancer despite a slight change of exposure (about 6 - 18%).
Na podlagi študij medsebojnega delovanja zaviralcev proteaz, ojačenih z ritonavirjem (lopinavir/ ritonavir, atazanavir), sočasna uporaba omeprazola ali ranitidina na učinkovitost ritonavirja kot farmakokinetičnega stopnjevalca ne vpliva signifikantno, čeprav se izpostavljenost rahlo spremeni (okoli 6- 18%).
Ritonavir adversely interacts with oral contraceptives (OCs).
Podatki pri živalih so pokazali toksične učinke na sposobnost razmnoževanja (glejte poglavje 5. 3).
Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Uporaba Norvirja pride med nosečnostjo v poštev le, če koristi odtehtajo tveganje za plod.
20 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
As somnolence and dizziness are known undesirable effects, this should be taken into account when driving or using machinery.
Ker sta zaspanost in omotica znana neželena učinka, je to treba upoštevati, kadar naj bi bolnik vozil oz. upravljal s stroji.
Norvir oral solution contains alcohol (43%).
Peroralna raztopina Norvir vsebuje alkohol (43% V/ V).
4.8 Undesirable effects
20 4. 8 Neželeni učinki
Adverse events associated with the use of ritonavir as a pharmacokinetic enhancer are dependent on the specific co-administered PI.
Neželeni učinki, povezani z uporabo ritonavirja kot farmakokinetičnega stopnjevalca, so odvisni od specifičnega sočasno uporabljanega zaviralca proteaz.
For information on adverse events refer to the SPC of the specific co-administered PI.
Za informacije o neželenih učinkih glejte povzetek glavnih značilnosti sočasno uporabljenega zaviralca proteaz.
In the original clinical studies (Phase II/III), adverse events with possible, probable or unknown relationship to ritonavir were reported in ≥ 2% of 1033 patients.
V originalnih kliničnih študijah (II. / III. faza) so o neželenih učinkih, katerih povezanost z ritonavirjem je bila možna, verjetna ali neznana, poročali pri ≥ 2% od 1033 bolnikov.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1000 to < 1/100); rare( > 1/10,000 to < 1/1,000).
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti: zelo pogosto > 1/ 10; pogosto > 1/ 100 do < 1/ 10; občasno > 1/ 1000 do < 1/ 100; redko > 1/ 10, 000 do < 1/ 1, 000.
Undesirable Effects in Clinical Studies and Post-marketing in Adult Patients Immune system disorders
Neželeni učinki v kliničnih študijah in pomarketinškem obdobju pri odraslih bolnikih Bolezni imunskega sistema
Allergic reactions including urticaria, mild skin eruptions, bronchospasm and angioedema
Alergijske reakcije, vključno z urtikarijo, blagimi izpuščaji na koži, bronhospazmom in angioedemom
Anaphylaxis and Stevens Johnson syndrome
Anafilaksija in Stevens- Johnsonov sindrom
Decreased WBC, decreased haemoglobin, decreased neutrophils, increased eosinophils
Zmanjšanje števila levkocitov, znižanje hemoglobina, zmanjšanje števila nevtrofilcev, povečanje števila eozinofilcev
Increased WBC, increased neutrophils and increased prothrombin time
Povečanje števila levkocitov, povečanje števila nevtrofilcev in podaljšan protrombinski čas
Unknown frequency
Neznana
Metabolic and nutritional disorders
pogostnost Presnovne in prehranske motnje
Dehydration, diabetes mellitus
Dehidracija, diabetes mellitus
Hypertriglyceridaemia, hypercholesterolaemia, hyperuricaemia
Hipertrigliceridemija, hiperholesterolemija,
Taste perversion, circumoral and peripheral paresthesia, headache
Spremembe okusa, parestezija okrog ust in periferna parestezija, glavobol
Dizziness, paraesthesia, hyperaesthesia, somnolence, insomnia, anxiety
Omotica, parestezija, hiperestezija, zaspanost, nespečnost, anksioznost
21
Neznana
Unknown frequency
Konvulzije, sinkopa
Seizure, syncope
pogostnost
Vasodilation
Vazodilatacija
Respiratory, thoracic and mediastinal disorders
21 Bolezni dihal, prsnega koša in mediastinalnega prostora
Pharyngitis, cough increased
Faringitis, močnejši kašelj
Abdominal pain, nausea, diarrhoea, vomiting
Bolečine v trebuhu, navzea, driska, bruhanje
Dyspepsia, anorexia, local throat irritation, flatulence, dry mouth, eructation, mouth ulcer
Dispepsija, anoreksija, lokalno draženje žrela, flatulenca, suha usta, spahovanje, razjede v ustih
Hepatitis and jaundice
Hepatitis in zlatenica
Rash, pruritus, sweating, lipodystrophy
Izpuščaj, srbenje, znojenje, lipodistrofija
Musculosketal and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Increased CPK, myalgia
Zvišana CPK, mialgija
Myositis, rhabdomyolysis
Miozitis, rabdomioliza
Reproductive system and breast disorders
pogostnost Motnje reprodukcije in dojk
Menorrhagia
Menoragija
General disorders and administration site conditions
pogostnost Splošne težave in spremembe na mestu aplikacije
Asthenia
Astenija
Fever, pain weight loss
Zvišana telesna temperatura, bolečine, hujšanje
Increased GGT, increased CPK, increased triglycerides, increased SGPT, increased SGOT, increased amylase, increased uric acid, decreased potassium, decreased free and total thyroxin
Zvišanje GGT, zvišanje CPK, zvišanje trigliceridov, zvišanje SGPT, zvišanje SGOT, zvišanje amilaze, zvišanje sečne kisline; znižanje kalija, znižanje prostega in celotnega tiroksina
Increased glucose, decreased total calcium, increased magnesium, increased bilirubin, increased alkaline phosphatase
Zvišanje glukoze, znižanje celotnega kalcija, zvišanje magnezija, zvišanje bilirubina, zvišanje alkalne fosfataze
Events noted as having Unknown frequency were identified via post-marketing surveillance.
Učinki, ki imajo navedeno neznano pogostnost, so bili ugotovljeni med pomarketinškim spremljanjem.
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).
Pri bolnikih, okuženih s HIV, so kombinirano protiretrovirusno zdravljenje povezovali 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).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano protiretrovirusno terapijo so povezovali s presnovnimi nepravilnostmi, npr. hipertrigliceridemijo, hiperholesterolemijo, odpornostjo proti insulinu, hiperglikemijo in hiperlaktatemijo (glejte poglavje 4. 4).
22 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).
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).
Pancreatitis has been observed in patients receiving ritonavir therapy, including those who developed hypertriglyceridemia.
22 Pri nekaterih bolnikih, zdravljenih z ritonavirjem, vključno s tistimi, ki so doživeli hipertrigliceridemijo, se je pojavil pankreatitis.
Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis (see section 4.4).
Bolnike z napredovalo boleznijo HIV utegneta ogrožati zvišanje trigliceridov in pankreatitis (glejte poglavje 4. 4).
One patient in clinical trials took ritonavir 1500 mg/day for two days and reported paraesthesia, which resolved after the dose was decreased.
V kliničnih preskušanjih je en bolnik dva dni jemal 1. 500 mg ritonavirja na dan; navajal je parestezije, ki so po zmanjšanju odmerka izginile.
Pharmaco-therapeutic group: antiviral for systemic use, ATC code:
Oznaka ATC:
For additional information on the effect of ritonavir on co-administered protease inhibitor metabolism, see section 4.5 and refer to the Summary of Product Characteristics of the particular co-administered PIs.
Za dodatne informacije o učinku ritonavirja na presnovo sočasno uporabljenega zaviralca proteaz glejte poglavje 4. 5 in povzetek glavnih značilnosti za posamezni sočasno uporabljeni zaviralec proteaz.
Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases.
Ritonavir je peroralno aktiven peptidomimetični zaviralec aspartilproteaz HIV- 1 in HIV- 2.
Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection.
Zavrtje HIV- proteaz encimu onemogoči obdelavo poliproteinskega predhodnika gag- pol; tako nastajajo morfološko nezreli delci HIV, nezmožni za sprožanje novih ciklusov okužbe.
Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases.
Ritonavir ima selektivno afiniteto za HIV- proteaze in le malo zavira človeške aspartilproteaze.
However, due to ritonavir’s metabolic inhibitory properties its use as a 23 pharmacokinetic enhancer of other protease inhibitors is the prevalent use of ritonavir in clinical practice (see section 4.2).
Toda ker ritonavir zavira presnovo, se v klinični praksi pretežno uporablja kot farmakokinetični stopnjevalec drugih zaviralcev proteaz (glejte poglavje 4. 2).
QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
23 Interval QTcF so ocenili v randomizirani, s placebom in zdravilno učinkovino (moksifloksacin 400 mg enkrat na dan) kontrolirani navzkrižni študiji pri 45 zdravih odraslih, ki so jim 3. dan v 12 urah naredili 10 meritev.
The maximum mean (95% upper confidence bound) difference in QTcF from placebo was 5.5 (7.6) for 400 mg twice daily ritonavir.
Največja povprečna razlika (95% zgornja meja zaupanja) QTcF v primerjavi s placebom je bila 5, 5 (7, 6) med uporabo ritonavirja 400 mg dvakrat na dan.
The Day 3 ritonavir exposure was approximately 1.5 fold higher than that observed with the 600 mg twice daily dose at steady state.
Med tema režimoma uporabe je bila izpostavljenost 3. dan 1, 5- krat večja kot med uporabo 600 mg odmerka ritonavirja dvakrat na dan v stanju dinamičnega ravnovesja.
The mean changes from baseline in PR interval ranged from 11.0 to 24.0 msec in the 12 hour interval post dose.
Povprečna sprememba dolžine intervala PR v primerjavi z izhodiščem je bila med 12- urnim obdobjem po odmerku od 11, 0 msec do 24, 0 msec.
Maximum PR interval was 252 msec and no second or third degree heart block was observed (see section 4.4).
Najdaljši interval PR je bil 252 msec, primerov srčnega bloka druge ali tretje stopnje pa ni bilo (glejte poglavje 4. 4).
Ritonavir-resistant isolates of HIV-1 have been selected in vitro and isolated from patients treated with therapeutic doses of ritonavir.
Izolati HIV- 1, odporni proti ritonavirju, so bili selekcionirani in vitro in izolirani pri bolnikih, zdravljenih s terapevtskimi odmerki ritonavirja.
Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Zmanjšanje protiretrovirusnega delovanja ritonavirja je v prvi vrsti povezano z mutacijami proteaz V82A/ F/ T/ S in I84V.
The effects of ritonavir (alone or combined with other antiretroviral agents) on biological markers of disease activity such as CD4 cell count and viral RNA were evaluated in several studies involving HIV-1 infected patients.
Učinke ritonavirja (samega ali v kombinaciji z drugimi protiretrovirusnimi učinkovinami) na biološke označevalce aktivnosti bolezni, npr. število celic CD4 in virusno RNA, so ocenili v več študijah bolnikov, okuženih s HIV- 1.
A controlled study completed in 1996 with ritonavir as add-on therapy in HIV-1 infected patients extensively pre-treated with nucleoside analogues and baseline CD4 cell counts ≤ 100 cells/μl showed a reduction in mortality and AIDS defining events.
Kontrolirana študija, dokončana leta 1996, ritonavirja kot dodatnega zdravila pri bolnikih, okuženih s HIV- 1, predhodno izdatno zdravljenih z nukleozidnimi analogi in z izhodiščnim številom celic CD4 ≤ 100 celic/ μl, je pokazala zmanjšanje umrljivosti in dogodkov, ki opredeljujejo AIDS.
The mean average change from baseline over 16 weeks for HIV RNA levels was -0.79 log10 (maximum mean decrease:
Srednja povprečna sprememba v primerjavi z izhodiščno koncentracijo HIV RNA v 16 tednih je bila – 0, 79 log10 (največje srednje zmanjšanje:
1.29 log10) in the ritonavir group versus-0.01 log10 in the control group.
1, 29 log10) v skupini, ki je prejemala ritonavir, v primerjavi z – 0, 01 log10 v kontrolni skupini.
In a study completed in 1996 recruiting less advanced HIV-1 infected patients (CD4 200-500 cells/μl) without previous antiretroviral therapy, ritonavir in combination with zidovudine or alone reduced viral load in plasma and increased CD4 count.
V študiji, dokončani leta 1996, ki je zajela bolnike z manj napredovalo okužbo s HIV- 1 (200- 500 celic CD4/ μl) brez predhodnega protiretrovirusnega zdravljenja, je ritonavir v kombinaciji z zidovudinom ali sam zmanjšal virusno breme v plazmi in zvečal število celic CD4.
The mean average change from baseline over 48 weeks for HIV RNA levels was -0.88 log10 in the ritonavir group versus -0.66 log10 in the ritonavir + zidovudine group versus -0.42 log10 in the zidovudine group.
Srednja povprečna sprememba v primerjavi z izhodiščno koncentracijo HIV RNA v 48 tednih je bila – 0, 88 log10 v skupini na ritonavirju, – 0, 66 log10 v skupini na ritonavirju in zidovudinu ter – 0, 42 log10 v skupini na zidovudinu.
The continuation of ritonavir therapy should be evaluated by viral load because of the possibility of the emergence of resistance as described under section 4.1 Therapeutic indications.
Nadaljevanje zdravljenja z ritonavirjem je treba ocenjevati z virusnim bremenom, ker obstaja možnost odpornosti, kot je opisano v poglavju 4. 1 Terapevtske indikacije.