FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov
English: 300/75 mg/m2 (corresponding to 3.75 ml/m2)
Slovenian: 300/75 mg/m2 (kar ustreza 3,75 ml/m2)
English: • breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream;
Slovenian: - razpad mišičnih vlaken, ki privede do sproščanja vsebine mišičnih vlaken (mioglobina) v krvni obtok;
English: Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only.
Slovenian: Kontraindiciran je samo v primeru uporabe za zdravljenje pljučne arterijske hipertenzije (PAH).
English: 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).
Slovenian: 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).
English: Due to induction of lamotrigine glucuronidation
Slovenian: Zaradi indukcije glukuronidacije lamotrigina.
English: Increased plasma concentrations of alfuzosin which may lead to severe hypotension.
Slovenian: Večja koncentracija alfuzosina v plazmi, ki lahko povzroči hudo hipotenzijo.
English: 4 tablets (400/100 mg) 5 tablets (500/125 mg)
Slovenian: 4 tablete (400/100 mg) 5 tablet (500/125 mg)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Both treatment arms included zidovudine 180 mg/m2 every 12 hours and lamivudine 4 mg/kg every 12 hours.
Slovenian: Zdravljenje v obeh skupinah je vključevalo tudi zidovudin 180 mg/m2 vsakih 12 ur in lamivudin 4 mg/kg vsakih 12 ur.
English: 16/4 mg/kg (corresponding to 0.2 ml/kg)
Slovenian: 16/4 mg/kg (kar ustreza 0,2 ml/kg)
English: 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.
Slovenian: 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.
English: Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Slovenian: Na temelju znanih presnovnih značilnosti ni pričakovati klinično pomembnega medsebojnega delovanja zdravila Kaletra in dapsona, trimetoprima/sulfametoksazola, azitromicina ali flukonazola.
English: Not known Stevens-Johnson syndrome, erythema multiforme
Slovenian: Stevens-Johnsonov sindrom, multiformni eritem
English: C24: ↑ 20.70-fold
Slovenian: C24: ↑ 20,70-krat
English: High density polyethylene (HDPE) bottles closed with propylene caps.
Slovenian: Plastenke iz polietilena velike gostote (HDPE), zaprte s propilensko zaporko.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with lopinavir/ritonavir and close monitoring should be performed during treatment.
Slovenian: Pred začetkom zdravljenja z lopinavirjem/ritonavirjem je potrebno ustrezno laboratorijsko testiranje, med zdravljenjem pa strogo nadzorovanje.
English: The dose should be administered using a calibrated 2 ml or 5 ml oral dosing syringe best corresponding to the volume prescribed.
Slovenian: Za dajanje odmerka je treba uporabiti kalibrirano 2 ml ali 5 ml brizgo za peroralno dajanje, ki najbolj ustreza predpisanemu volumnu.
English: The combined effects may lead to increased blood alcohol levels and increase the side effects of alcohol.
Slovenian: Združeni učinki lahko povzročijo večjo koncentracijo alkohola in povečajo neželene učinke alkohola.
English: 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.
Slovenian: 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.
English: Paediatric Use
Slovenian: Pediatrična uporaba
English: Because Kaletra oral solution contains alcohol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.
Slovenian: Ker zdravilo Kaletra peroralna raztopina vsebuje alkohol, ga zaradi potencialne nekompatibilnosti ni priporočljivo uporabljati s cevkami za hranjenje iz poliuretana.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • If you realise you have taken more Kaletra than you were supposed to, contact your doctor right away.
Slovenian: - Če ugotovite, da ste vzeli več zdravila Kaletra, kot bi bilo treba, se takoj posvetujte s svojim zdravnikom.
English: Therefore, it is reasonable to expect that cardiac lopinavir levels would not be significantly higher than plasma levels.
Slovenian: Zato je smiselno pričakovati, da koncentracija lopinavirja v srcu ni pomembno večja od koncentracije v plazmi.
English: However, only the increase in voxilaprevir exposure is considered clinically relevant.
Slovenian: Vseeno pa je klinično pomembno le povečanje izpostavljenosti voksilaprevirju.
English: Treatment emergent adverse events led to premature study discontinuation for 7% of subjects from Phase II-IV studies.
Slovenian: Hudi neželeni učinki, ki so se pojavili med zdravljenjem, so vodili do predčasne prekinitve terapije pri 7% bolnikov v študijah II.-IV. faze.
English: Mean age of patients enrolled was 39 years (range: 19 to 71); 75% were Caucasian, and 78% were male.
Slovenian: Povprečna starost vključenih bolnikov je bila 39 let (razpon:od 19 do 71); 75 % je bilo belcev in 78 % je bilo moških.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
English: Each bottle contains 120 tablets.
Slovenian: Ena plastenka vsebuje 120 tablet.
English: HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Slovenian: Izolati HIV-1 z zmanjšano občutljivostjo za lopinavir so bili izbrani in vitro.
English: Hazard Ratio for Death or Failure of First-line Therapy Relative to ART Deferred Treatment: CHER Study 40 week arm (N=13)
Slovenian: Razmerje tveganja za smrt ali neuspeh zdravljenja prve izbire v primerjavi z odloženim protiretrovirusnim zdravljenjem: Študija CHER Skupina s 40-tedenskim zdravljenjem (N=13)
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Slovenian: Zaviralci CYP3A4 povečajo izpostavljenost lomitapida, v primeru močnih zaviralcev se izpostavljenost poveča za približno 27-krat.
English: Therefore, combination of bedaquiline with lopinavir/ritonavir should be avoided.
Slovenian: Zato se je treba izogibati kombinaciji bedakilina z lopinavirjem/ritonavirjem.
English: Postpartum n = 17**
Slovenian: Poporodno obdobje n = 17**
English: M98-940 was an open-label study of a liquid formulation of Kaletra in 100 antiretroviral naïve (44%) and experienced (56%) paediatric patients.
Slovenian: M98-940 je odprta študija tekočega pripravka zdravila Kaletra pri 100 protiretrovirusno naivnih (44%) in izkušenih (56 %) pediatričnih bolnikih.
English: Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions.
Slovenian: Močni zaviralci CYP3A4 kot so zaviralci proteaz lahko povečajo izpostavljenost bedakilinu, kar bi potencialno lahko povečalo tveganje za neželene učinke povezane z bedakilinom.
English: 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.
Slovenian: 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.
English: ≥ 15 to 40 kg
Slovenian: ≥ 15 do 40 kg
English: Hepatitis C virus direct acting antivirals
Slovenian: Zdravila z direktnim delovanjem proti virusu hepatitisa C
English: 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.
Slovenian: Alkohol in propilenglikol lahko škodujeta bolnikom z boleznijo jeter, boleznijo ledvic, alkoholizmom, epilepsijo, okvaro ali boleznijo možganov ter nosečnicam in otrokom.
English: Subsequently, all patients were continued on the 300/75 mg per m2 dose.
Slovenian: Potem so vsi bolniki nadaljevali z odmerkom 300/75 mg na m2.
English: Increased plasma concentrations of quetiapine which may lead to coma.
Slovenian: Zvišana plazemska koncentracija kvetiapina, ki lahko vodi v komo.
English: Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope).
Slovenian: Zaradi tega večja možnost neželenih učinkov, povezanih s sildenafilom (med takšnimi sta hipotenzija in sinkopa).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Slovenian: Kar zadeva učinkovitost in varnost, primerni odmerki te kombinacije niso ugotovljeni.
English: Antipsychotics Lurasidone
Slovenian: Antipsihotiki Lurasidon
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: Antimycobacterials Bedaquiline (single dose)
Slovenian: Protimikobakterijska zdravila Bedakilin (enkratni odmerek)
English: Omeprazole: ↔ Lopinavir: ↔
Slovenian: Omeprazol: ↔ Lopinavir: ↔
English: • Do not use Kaletra after the expiry date which is stated on the bottle.
Slovenian: - Zdravila Kaletra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenički.
English: An increase of the dose of Kaletra to 300/75 mg/m2 is needed in these patients.
Slovenian: Pri teh bolnikih je treba povečati odmerek zdravila Kaletra na 300/75 mg/m2.
English: • 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.
Slovenian: - 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.
English: • abnormal closure of one of the valves (tricuspid valve in your heart);
Slovenian: - tresavica; - nenormalno zapiranje ene od zaklopk (trikuspidalna valva v vašem srcu); - vrtoglavica (vertigo);
English: 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.
Slovenian: 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.
English: • It is important that all doses of Kaletra oral solution are taken with food.
Slovenian: - Pomembno je, da vse odmerke zdravila Kaletra peroralna raztopina vzamete s hrano.
English: Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Slovenian: Večja koncentracija tenofovirja bi lahko povečala z njim povezane neželene učinke, vključno z ledvičnimi motnjami.
English: Ritonavir has been shown to induce metabolic enzymes, resulting in the induction of its own metabolism, and likely the induction of lopinavir metabolism.
Slovenian: Ritonavir dokazano inducira presnovne encime; posledica je indukcija njegove lastne presnove, verjetno pa tudi indukcija presnove lopinavirja.
English: The Kaletra dose should be titrated upward only after rifampicin has been initiated (see section 4.4).
Slovenian: Odmerek zdravila Kaletra je treba povečati šele po uvedbi rifampicina (glejte poglavje 4.4).
English: Pravastatin is not metabolised by CYP450.
Slovenian: Presnova pravastatina ne poteka s CYP450.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Slovenian: Indukcijski učinek lahko traja še vsaj 2 tedna po prenehanju zdravljenja s šentjanževko (glejte poglavje 4.3).
English: • you are allergic to lopinavir, ritonavir or any of the other ingredients of Kaletra (see section 6); • you have severe liver problems.
Slovenian: - ste alergični na lopinavir, ritonavir ali katerokoli sestavino tega zdravila (navedeno v poglavju 6); - imate hude težave z jetri.
English: Kaletra should be used with caution in such patients (see section 5.1).
Slovenian: Zdravilo Kaletra morate pri takšnih bolnikih uporabljati previdno (glejte poglavje 5.1).
English: Overdoses with Kaletra oral solution have been reported (including fatal outcome).
Slovenian: Opisani so bili primeri prevelikega odmerjanja zdravila Kaletra peroralna raztopina (vključno s smrtnim izidom).
English: If the benefit is considered to outweigh the risk and Kaletra must be used, patients should be carefully monitored for safety.
Slovenian: Če korist odtehta tveganje, je treba zdravilo Kaletra uporabiti in bolnika pozorno spremljati glede varnosti.
English: For volumes up to 2 ml.
Slovenian: Za volumne do 2 ml.
English: Particular caution should be used when prescribing sildenafil or tadalafil for the treatment of erectile dysfunction in patients receiving Kaletra.
Slovenian: Posebna previdnost je potrebna pri predpisovanju sildenafila ali tadalafila za zdravljenje erektilne disfunkcije bolnikom, ki dobivajo zdravilo Kaletra.
English: Clinical results
Slovenian: KLINIČNI PODATKI
English: QD BID Difference [95% CI]
Slovenian: Razlika [95 % IZ]
English: Antipsychotics/ Neuroleptics
Slovenian: Antipsihotiki/nevroleptiki Lurasidon
English: Anxiety Uncommon Abnormal dreams, libido decreased
Slovenian: Psihiatrične motnje pogosti anksioznost občasni nenormalne sanje, zmanjšan libido
English: Do not take Kaletra with any of the following medicines:
Slovenian: Ne jemljite zdravila Kaletra, če trenutno jemljete katero od naslednjih zdravil:
English: Plasma concentrations of lopinavir were measured over four 12-hour periods during second trimester (20-24 weeks gestation), third trimester before dose increase (30 weeks gestation), third trimester after dose increase (32 weeks gestation), and at 8 weeks post-partum.
Slovenian: Plazemske koncentracije lopinavirja so bile izmerjene v štirih 12-urih obdobjih med drugim trimesečjem (20 - 24 tednov gestacijske dobe), tretjim trimesečjem pred povečanjem odmerka (30 tednov gestacijske dobe), tretjim trimesečjem po povečanju odmerka (32 tednov gestacijske dobe) in pri 8 tednih po porodu.
English: Tell your doctor if you or your child experience
Slovenian: Povejte svojemu zdravniku, če vi ali vaš otrok doživite kaj od naslednjega
English: Kaletra is administered orally and should always be taken with food (see section 5.2).
Slovenian: Zdravilo Kaletra se jemlje peroralno in vedno s hrano (glejte poglavje 5.2).
English: Kaletra has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation.
Slovenian: In vivo je dokazano, da zdravilo Kaletra inducira svojo lastno presnovo in zvečuje biotransformacijo nekaterih zdravil, ki se presnavljajo z encimi citokroma P450 (vključno s CYP2C9 in CYP2C19) in z glukuronidacijo.
English: 7 to < 15 kg
Slovenian: 7 do < 15 kg
English: • decreased sexual desire;
Slovenian: - zmanjšana želja po spolnosti; - vnetje ledvic;
English: Felodipine, Nifedipine, Nicardipine:
Slovenian: Felodipin, nifedipin in nikardipin
English: Unsuitable in hereditary fructose intolerance.
Slovenian: To je neprimerno pri podedovani intoleranci za fruktozo.
English: 7 to 10 kg > 10 to < 15 kg
Slovenian: 7 do 10 kg > 10 do < 15 kg
English: • The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
Slovenian: - Običajni odmerek za odrasle je 400 mg/100 mg dvakrat na dan, to je vsakih 12 ur, v kombinaciji z drugimi zdravili proti HIV.
English: Fentanyl:
Slovenian: Fentanil:
English: Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor's supervision (see Other medicines and Kaletra section);
Slovenian: Fusidno kislino za zdravljenje dolgotrajnih okužb kosti in sklepov se sme uporabljati pod nadzorstvom zdravnika (glejte poglavje Druga zdravila in zdravilo Kaletra);
English: Adverse reactions from clinical trials and post-marketing experience in adult and paediatric patients: The following events have been identified as adverse reactions.
Slovenian: Neželeni učinki v kliničnih študijah in iz obdobja trženja zdravila pri odraslih in pediatričnih bolnikih: Opisani so bili naslednji neželeni dogodki.
English: • Always keep enough Kaletra on hand so you don't run out.
Slovenian: - Vedno imejte pri roki dovolj zdravila Kaletra, da vam je ne bo zmanjkalo.
English: The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4+ T-cell counts) have been investigated in controlled studies of Kaletra of 48 to 360 weeks duration.
Slovenian: Učinke zdravila Kaletra (v kombinaciji z drugimi protiretrovirusnimi zdravili) na biološke označevalce (koncentracijo HIV RNA in število T-celic CD4 v plazmi) so raziskali v kontrolirani 48tedenski študiji zdravila Kaletra ter v dodatnih 360-tedenskih študijah zdravila Kaletra.
English: While rosuvastatin is poorly metabolised by CYP3A4, an increase of its plasma concentrations was observed.
Slovenian: Ker se rosuvastatin slabo presnavlja s CYP3A4, so opažali zvišanje koncentracije v plazmi.
English: The effective (peak to trough) half-life of lopinavir over a 12 hour dosing interval averaged 5 − 6 hours, and the apparent oral clearance (CL/F) of lopinavir is 6 to 7 l/h.
Slovenian: Efektivni (od vrha do dna) razpolovni čas lopinavirja v 12-urnem odmernem intervalu je bil v povprečju od 5 do 6 ur, navidezni peroralni očistek (CL/F) lopinavirja pa je 6 do 7 l/h.
English: In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults (see Table in section b).
Slovenian: d. Pediatrična populacija Pri otrocih, starih 2 leti in več, je varnostni profil podoben kot pri odraslih (glejte preglednico v razdelku b).
English: Maraviroc:
Slovenian: Maravirok:
English: The study did not contain a control arm of patients not receiving Kaletra.
Slovenian: Študija ni obsegala kontrolnega kraka bolnikov brez zdravila Kaletra.