natgillin/translations-raw huggingface dataset:
Long-term carcinogenicity studies of lopinavir/ritonavir in mice revealed a nongenotoxic, mitogenic induction of liver tumours, generally considered to have little relevance to human risk. 
Dolgotrajne študije lopinavirja/ritonavirja pri miših so pokazale negenotoksično, mitogeno indukcijo jetrnih tumorjev, za katero na splošno velja, da je malo pomembna za tveganje pri človeku.
Patients were administered at least two nucleoside/nucleotide reverse transcriptase inhibitors selected by the investigator. 
Bolniki so dobivali vsaj dva zaviralca nukleozidne/nukleotidne reverzne transkriptaze, ki ju je izbral raziskovalec.
Greater effects may be expected when fluticasone propionate is inhaled. 
Med vdihavanjem flutikazonpropionata je mogoče pričakovati večje učinke.
Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending lopinavir/ritonavir treatment. 
Pri bolnikih, ki se zdravijo z levotiroksinom, je treba spremljati ščitnico stimulirajoči hormon (TSH) vsaj prvi mesec po začetku in/ali koncu zdravljenja z lopinavirjem/ritonavirjem.
When you travel or need to stay in the hospital make sure you will have enough Kaletra to last until you can get a new supply. 
Če greste na potovanje ali v bolnišnico, imejte s seboj vedno toliko zdravila Kaletra, da vam bo zadostovalo, dokler ne dobite nove zaloge.
If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. 
Če je indicirano, je odstranitev neabsorbirane zdravilne učinkovine mogoče doseči z bruhanjem ali izpiranjem želodca.
There are limited pharmacokinetic data in children below 2 years of age. 
Pediatrični bolniki Farmakokinetični podatki pri otrocih do 2. leta starosti so omejeni.
Other medicines and Kaletra); 
Druga zdravila in zdravilo Kaletra);
Adequate exposure to lopinavir/ritonavir may be achieved when a higher dose of Kaletra is used but this is associated with a higher risk of liver and gastrointestinal toxicity. 
Zadostno izpostavljenost kombinaciji lopinavir/ritonavir se lahko doseže z uporabo višjega odmerka zdravila Kaletra, vendar je to povezano z večjim tveganjem za jetrno in gastrointestinalno toksičnost.
Caution is warranted and therapeutic drug concentration monitoring is recommended when available. 
Potrebna je previdnost in priporočljivo je nadziranje terapevtske koncentracije zdravila, če je to mogoče.
The pharmacokinetic properties of lopinavir co-administered with ritonavir have been evaluated in healthy adult volunteers and in HIV-infected patients; no substantial differences were observed between the two groups. 
Farmakokinetične lastnosti lopinavirja, uporabljenega hkrati z ritonavirjem, so ocenili pri zdravih odraslih prostovoljcih in pri bolnikih, okuženih s HIV; med skupinama niso opazili bistvenih razlik.
• alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH)); 
- alfuzosin (uporablja se pri moških za zdravljenje simptomov povečane prostate (benigne hiperplazije prostate (BHP));
Genotypic correlates of reduced phenotypic susceptibility to lopinavir in viruses selected by other protease inhibitors. 
Genotipski korelati manjše fenotipske občutljivosti za lopinavir pri virusih, selekcioniranih z drugimi zaviralci proteaz.
Tell your doctor if you or your child have/had 
Povejte svojemu zdravniku, če vi ali vaš otrok imate ali ste imeli
Kaletra contains glycerol which is harmful in high doses. 
Zdravilo Kaletra vsebuje glicerol, ki je v velikih odmerkih škodljiv.
(inhibition of CYP3A/efflux transporters) 
(zavrtje CYP3A/efluksnih transporterjev)
If you are not sure how to use the oral dosing syringe ask your doctor, pharmacist or nurse. 
Če niste prepričani, kako uporabljati brizgo za peroralno dajanje, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus). 
Pri 19 izolatih so ugotovili 4,3-kratno povečanje IC50 v primerjavi z izhodiščnimi izolati (od 6,2- do 43-kratno v primerjavi z divjim tipom virusa).
Particular caution must be used when prescribing Kaletra and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin. 
Posebna previdnost je potrebna pri predpisovanju zdravila Kaletra in zdravil, ki podaljšujejo interval QT; takšna so npr. klorfeniramin, kinidin, eritromicin, klaritromicin.
The absolute bioavailability of lopinavir co-formulated with ritonavir in humans has not been established. 
Absolutna biološka uporabnost lopinavirja, koformuliranega z ritonavirjem, pri ljudeh ni ugotovljena.
Carcinogenicity studies in rats revealed no tumourigenic findings. 
Raziskave kancerogenosti pri podganah niso pokazale tumorigenosti.
If treatment with an HMG-CoA reductase inhibitor is indicated, 
Če je indicirano zdravljenje z zaviralcem reduktaze HMG-CoA,
As compared to the BID regimen, the once-daily dosing is associated with a reduction in the Cmin/Ctrough values of approximately 50%. 
V primerjavi s shemo dvakrat na dan je bilo odmerjanje enkrat na dan povezano z zmanjšanjem vrednosti Cmin/Ctrough za približno 50 %.
Do not shake the bottle - this is because air bubbles can form which will affect how well you can measure the dose. 
Plastenke ne stresajte, ker lahko nastanejo zračni mehurčki, ki bodo vplivali na natančnost pri odmerjanju.
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. 
Pri bolnikih z obstoječo disfunkcijo jeter, vključno s kroničnim hepatitisom, se med kombiniranim protiretrovirusnim zdravljenjem pogosteje pojavljajo nepravilnosti v delovanju jeter, zato jih je treba nadzirati v skladu s standardno prakso.
The systemic exposure to lopinavir/ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans. 
Sistemska izpostavljenost lopinavirju/ritonavirju je bila ob maternalnih in razvojno toksičnih odmerkih manjša, kot je predvidena terapevtska izpostavljenost pri človeku.
Like all medicines, Kaletra can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Kaletra neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Can cause headache and stomach upset and diarrhoea. 
Povzroči lahko glavobol, želodčne težave in drisko.
• Do not stop or change the daily dose of Kaletra without first consulting with your doctor. 
- Dnevnega odmerka zdravila Kaletra ne opuščajte in ne spreminjajte, ne da bi se prej posvetovali z zdravnikom.
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. 
Lopinavir je zaviralec proteaz HIV-1 in
‘ml' mark 
Oznaka z ‘ml'
Initially, bosentan Cmin: ↑ by approximately 48-fold. 
Uvodoma Cmin bosentana: ↑ za približno 48-krat.
• an abnormality in your electrocardiogram (ECG) called atrioventricular block; 
- izpadanje las; - nenormalnost v elektrokardiogramu (EKG), ki se imenuje atrioventrikularni blok;
Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis. 
Bolnike z napredovalo boleznijo HIV utegneta ogrožati zvišanje trigliceridov in pankreatitis.
In case of co-administration of Kaletra with contraceptives containing ethinyl oestradiol (whatever the contraceptive formulation e.g. oral or patch), additional methods of contraception must be used. 
Kaletra s kontraceptivi, ki vsebujejo etinilestradiol (ne glede na formulacijo kontraceptiva, npr. peroralni ali obliž), je treba uporabiti dodatne načine kontracepcijske zaščite.
Volume of oral solution twice daily taken with food (80 mg lopinavir/20 mg ritonavir per ml)** 
Volumen peroralne raztopine dvakrat na dan skupaj s hrano (80 mg lopinavirja/20 mg ritonavirja na ml)**
Study P1060 was a randomised controlled trial of nevirapine versus lopinavir/ritonavir-based therapy in subjects 2 to 36 months of age infected with HIV-1 who had (Cohort I) and had not (Cohort II) been exposed to nevirapine during pregnancy for prevention of mother-to-child transmission. 
Študija P1060 je bilo randomizirano, kontrolirano preskušanje zdravljenja z nevirapinom v primerjavi z zdravljenjem s kombinacijo lopinavirja/ritonavirja pri preiskovancih, starih od 2 do 36 mesecev, okuženih z virusom HIV-1, ki so bili izpostavljeni (kohorta I) in ki niso bili izpostavljeni (kohorta II) nevirapinu med nosečnostjo, za preprečevanje prenosa okužbe z mame na otroka.
Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur. 
Na pankreatitis je treba pomisliti, če se pojavijo klinični simptomi (navzeja, bruhanje, bolečine v trebuhu) ali nenormalne laboratorijske vrednosti (npr. zvišanje serumske lipaze ali amilaze), ki nakazujejo pankreatitis.
Very common: may affect more than 1 in 10 people 
Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov
300/75 mg/m2 (corresponding to 3.75 ml/m2) 
300/75 mg/m2 (kar ustreza 3,75 ml/m2)
• breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream; 
- razpad mišičnih vlaken, ki privede do sproščanja vsebine mišičnih vlaken (mioglobina) v krvni obtok;
Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. 
Kontraindiciran je samo v primeru uporabe za zdravljenje pljučne arterijske hipertenzije (PAH).
Cardiac events have been reported with Kaletra in preclinical studies; therefore, the potential cardiac effects of Kaletra cannot be currently ruled out (see sections 4.8 and 5.3). 
V predkliničnih raziskavah z zdravilom Kaletra so poročali o kardialnih incidentih, zato možnih učinkov zdravila Kaletra na srce trenutno ni mogoče izključiti (glejte poglavji 4.8 in 5.3).
Due to induction of lamotrigine glucuronidation 
Zaradi indukcije glukuronidacije lamotrigina.
Increased plasma concentrations of alfuzosin which may lead to severe hypotension. 
Večja koncentracija alfuzosina v plazmi, ki lahko povzroči hudo hipotenzijo.
4 tablets (400/100 mg) 5 tablets (500/125 mg) 
4 tablete (400/100 mg) 5 tablet (500/125 mg)
Overall, the in vitro characterisation of phenotypic cross-resistance between lopinavir and other protease inhibitors suggest that decreased susceptibility to lopinavir correlated closely with decreased susceptibility to ritonavir and indinavir, but did not correlate closely with decreased susceptibility to amprenavir, saquinavir, and nelfinavir. 
V celoti gledano karakterizacija fenotipske navzkrižne odpornosti med lopinavirjem in drugimi zaviralci proteaz in vitro nakazuje, da manjša občutljivosti za lopinavir tesno korelira z manjšo občutljivostjo za ritonavir in indinavir, ne korelira pa tesno z manjšo občutljivostjo za amprenavir, sakvinavir in nelfinavir.
Co-administration of Kaletra and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse reactions. 
Sočasna uporaba zdravila Kaletra in zdravil, ki se primarno presnavljajo s CYP3A, lahko zveča koncentracijo drugega zdravila v plazmi, to pa lahko zveča ali podaljša njegove terapevtske in neželene učinke.
Both treatment arms included zidovudine 180 mg/m2 every 12 hours and lamivudine 4 mg/kg every 12 hours. 
Zdravljenje v obeh skupinah je vključevalo tudi zidovudin 180 mg/m2 vsakih 12 ur in lamivudin 4 mg/kg vsakih 12 ur.
16/4 mg/kg (corresponding to 0.2 ml/kg) 
16/4 mg/kg (kar ustreza 0,2 ml/kg)
Besides propylene glycol as described above, Kaletra oral solution contains alcohol (42% v/v) which is potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. 
Poleg propilenglikola, kot je opisano zgoraj, vsebuje peroralna raztopina zdravila Kaletra alkohol (42 % v/v), ki lahko škoduje bolnikom z boleznijo jeter, alkoholizmom, epilepsijo, možgansko okvaro ali boleznijo ter nosečnicam in otrokom.
Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole. 
Na temelju znanih presnovnih značilnosti ni pričakovati klinično pomembnega medsebojnega delovanja zdravila Kaletra in dapsona, trimetoprima/sulfametoksazola, azitromicina ali flukonazola.
Not known Stevens-Johnson syndrome, erythema multiforme 
Stevens-Johnsonov sindrom, multiformni eritem
C24: ↑ 20.70-fold 
C24: ↑ 20,70-krat
High density polyethylene (HDPE) bottles closed with propylene caps. 
Plastenke iz polietilena velike gostote (HDPE), zaprte s propilensko zaporko.
Appropriate laboratory testing should be conducted prior to initiating therapy with lopinavir/ritonavir and close monitoring should be performed during treatment. 
Pred začetkom zdravljenja z lopinavirjem/ritonavirjem je potrebno ustrezno laboratorijsko testiranje, med zdravljenjem pa strogo nadzorovanje.
The dose should be administered using a calibrated 2 ml or 5 ml oral dosing syringe best corresponding to the volume prescribed. 
Za dajanje odmerka je treba uporabiti kalibrirano 2 ml ali 5 ml brizgo za peroralno dajanje, ki najbolj ustreza predpisanemu volumnu.
The combined effects may lead to increased blood alcohol levels and increase the side effects of alcohol. 
Združeni učinki lahko povzročijo večjo koncentracijo alkohola in povečajo neželene učinke alkohola.
Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC. 
Raziskave porazdelitve v tkiva, opravljene na podganah, niso nakazale pomembnega kardialnega zadrževanja zdravilne učinkovine; 72-urna AUC v srcu je bila približno 50 % AUC, izmerjene v plazmi.
Paediatric Use 
Pediatrična uporaba
Because Kaletra oral solution contains alcohol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility. 
Ker zdravilo Kaletra peroralna raztopina vsebuje alkohol, ga zaradi potencialne nekompatibilnosti ni priporočljivo uporabljati s cevkami za hranjenje iz poliuretana.
The percentage of patients with confirmed viral rebound >50 copies/ml during 48 weeks of follow-up was higher in the paediatric patients receiving lopinavir/ritonavir tablets once daily (12%) than in patients receiving the twice-daily dosing (8%, p = 0.19), mainly due to lower adherence in the once-daily group. 
Odstotek bolnikov s potrjenim virusnim preobratom >50 kopij/ml v obdobju 48 tednov spremljanja je bil večji pri pediatričnih bolnikih, ki so prejemali lopinavir/ritonavir tablete enkrat na dan (12 %), kot pri bolnikih, ki so prejemali odmerek dvakrat na dan (8 %, P=0,19), zlasti zaradi manjšega sodelovanja bolnikov v skupini, ki je prejemala odmerek enkrat na dan.
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 (e.g. beclomethasone). 
V poštev pride zmanjšanje odmerka glukokortikoida (ob tem je treba natančno kontrolirati lokalne in sistemske učinke), ali prehod na glukokortikoid, ki ni substrat CYP3A4 (npr. beklometazon).
• If you realise you have taken more Kaletra than you were supposed to, contact your doctor right away. 
- Če ugotovite, da ste vzeli več zdravila Kaletra, kot bi bilo treba, se takoj posvetujte s svojim zdravnikom.
Therefore, it is reasonable to expect that cardiac lopinavir levels would not be significantly higher than plasma levels. 
Zato je smiselno pričakovati, da koncentracija lopinavirja v srcu ni pomembno večja od koncentracije v plazmi.
However, only the increase in voxilaprevir exposure is considered clinically relevant. 
Vseeno pa je klinično pomembno le povečanje izpostavljenosti voksilaprevirju.
Treatment emergent adverse events led to premature study discontinuation for 7% of subjects from Phase II-IV studies. 
Hudi neželeni učinki, ki so se pojavili med zdravljenjem, so vodili do predčasne prekinitve terapije pri 7% bolnikov v študijah II.-IV. faze.
Mean age of patients enrolled was 39 years (range: 19 to 71); 75% were Caucasian, and 78% were male. 
Povprečna starost vključenih bolnikov je bila 39 let (razpon:od 19 do 71); 75 % je bilo belcev in 78 % je bilo moških.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia. 
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Each bottle contains 120 tablets. 
Ena plastenka vsebuje 120 tablet.
HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro. 
Izolati HIV-1 z zmanjšano občutljivostjo za lopinavir so bili izbrani in vitro.
Hazard Ratio for Death or Failure of First-line Therapy Relative to ART Deferred Treatment: CHER Study 40 week arm (N=13) 
Razmerje tveganja za smrt ali neuspeh zdravljenja prve izbire v primerjavi z odloženim protiretrovirusnim zdravljenjem: Študija CHER Skupina s 40-tedenskim zdravljenjem (N=13)
CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold. 
Zaviralci CYP3A4 povečajo izpostavljenost lomitapida, v primeru močnih zaviralcev se izpostavljenost poveča za približno 27-krat.
Therefore, combination of bedaquiline with lopinavir/ritonavir should be avoided. 
Zato se je treba izogibati kombinaciji bedakilina z lopinavirjem/ritonavirjem.
Postpartum n = 17** 
Poporodno obdobje n = 17**
M98-940 was an open-label study of a liquid formulation of Kaletra in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients. 
M98-940 je odprta študija tekočega pripravka zdravila Kaletra pri 100 protiretrovirusno naivnih (44%) in izkušenih (56 %) pediatričnih bolnikih.
Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions. 
Močni zaviralci CYP3A4 kot so zaviralci proteaz lahko povečajo izpostavljenost bedakilinu, kar bi potencialno lahko povečalo tveganje za neželene učinke povezane z bedakilinom.
HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during Kaletra therapy. 
HIV-1 je bil pasiran in vitro s samim lopinavirjem ter z lopinavirjem in ritonavirjem v koncentracijskih razmerjih, ki so predstavljala razpon koncentracijskih razmerij v plazmi, ugotovljenih med zdravljenjem z zdravilom Kaletra.
Hepatitis C virus direct acting antivirals 
Zdravila z direktnim delovanjem proti virusu hepatitisa C
Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, kidney disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. 
Alkohol in propilenglikol lahko škodujeta bolnikom z boleznijo jeter, boleznijo ledvic, alkoholizmom, epilepsijo, okvaro ali boleznijo možganov ter nosečnicam in otrokom.
Subsequently, all patients were continued on the 300/75 mg per m2 dose. 
Potem so vsi bolniki nadaljevali z odmerkom 300/75 mg na m2.
Increased plasma concentrations of quetiapine which may lead to coma. 
Zvišana plazemska koncentracija kvetiapina, ki lahko vodi v komo.
Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). 
Zaradi tega večja možnost neželenih učinkov, povezanih s sildenafilom (med takšnimi sta hipotenzija in sinkopa).
The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing. 
Uporabo enkrat na dan je treba omejiti na odrasle, ki imajo le zelo malo mutacij, povezanih z zaviralci proteaz (manj kot 3 takšne mutacije v skladu z rezultati klinične študije; za celoten opis populacije glejte poglavje 5.1), in upoštevati je treba tveganje manjše stalnosti virološke supresije (glejte poglavje 5.1) in večje tveganje driske (glejte poglavje 4.8) v primerjavi s priporočeno standardno uporabo dvakrat na dan. Za bolnike, ki imajo težave s požiranjem, je na voljo peroralna raztopina.
In patients starting or stopping Kaletra while currently taking maintenance dose of lamotrigine: lamotrigine dose may need to be increased if Kaletra is added, or decreased if Kaletra is discontinued; therefore plasma lamotrigine monitoring should be conducted, particularly before and during 2 weeks after starting or stopping Kaletra, in order to see if lamotrigine dose adjustment is needed. 
Pri uvedbi zdravila Kaletra bo morda potrebno povečati odmerek lamotrigina oz ga zmanjšati, če je zdravilo Kaletra ukinjeno; zato je potrebno nadzorovati koncentracijo lamotrigina v plazmi, še posebno dva tedna pred in po uvedbi ali prenehanju jemanja zdravila Kaletra, da se ugotovi, ali je potrebno odmerek lamotrigina prilagoditi ali ne.
The appropriate doses for this combination, with respect to efficacy and safety, have not been established. 
Kar zadeva učinkovitost in varnost, primerni odmerki te kombinacije niso ugotovljeni.
Antipsychotics Lurasidone 
Antipsihotiki Lurasidon
SPECIAL STORAGE CONDITIONS Store in a refrigerator 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
Antimycobacterials Bedaquiline (single dose) 
Protimikobakterijska zdravila Bedakilin (enkratni odmerek)
Omeprazole: ↔ Lopinavir: ↔ 
Omeprazol: ↔ Lopinavir: ↔
• Do not use Kaletra after the expiry date which is stated on the bottle. 
- Zdravila Kaletra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenički.
An increase of the dose of Kaletra to 300/75 mg/m2 is needed in these patients. 
Pri teh bolnikih je treba povečati odmerek zdravila Kaletra na 300/75 mg/m2.
• If you take sildenafil or tadalafil and Kaletra together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours. 
- Če sildenafil ali tadalafil in zdravilo Kaletra jemljete skupaj, vas lahko ogrožajo neželeni učinki kot npr. nizek krvni tlak, omedlevica, motnje vida in erekcija, ki traja več kot 4 ure.
• abnormal closure of one of the valves (tricuspid valve in your heart); 
- tresavica; - nenormalno zapiranje ene od zaklopk (trikuspidalna valva v vašem srcu); - vrtoglavica (vertigo);
No subject experienced an increase in QTcF of ≥ 60 ms from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 ms. 
Nobenemu preiskovancu se QTcF ni podaljšal za ≥ 60 msec v primerjavi z izhodiščem, dolžina intervala QTcF pa ni pri nobenem presegla potencialno klinično pomembnega praga 500 msec.
• It is important that all doses of Kaletra oral solution are taken with food. 
- Pomembno je, da vse odmerke zdravila Kaletra peroralna raztopina vzamete s hrano.
Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders. 
Večja koncentracija tenofovirja bi lahko povečala z njim povezane neželene učinke, vključno z ledvičnimi motnjami.
Ritonavir has been shown to induce metabolic enzymes, resulting in the induction of its own metabolism, and likely the induction of lopinavir metabolism. 
Ritonavir dokazano inducira presnovne encime; posledica je indukcija njegove lastne presnove, verjetno pa tudi indukcija presnove lopinavirja.
The Kaletra dose should be titrated upward only after rifampicin has been initiated (see section 4.4). 
Odmerek zdravila Kaletra je treba povečati šele po uvedbi rifampicina (glejte poglavje 4.4).
Pravastatin is not metabolised by CYP450. 
Presnova pravastatina ne poteka s CYP450.