FrancophonIA/ELRC3.0 huggingface dataset:
English: The following table contains dosing guidelines for Kaletra 100/25 mg tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Slovenian: Naslednja tabela prikazuje smernice za odmerjanje tablet zdravila Kaletra 100/25 mg glede na telesno površino, če so tablete pri otrocih uporabljene v kombinaciji z efavirenzem ali nevirapinom.
English: Antiretroviral Experienced (N=56)
Slovenian: Bolniki, ki so že bili zdravljeni s protiretrovirusnimi zdravili (N=56)
English: * intent to treat analysis where patients with missing values are considered virologic failures Paediatric Use
Slovenian: *analiza z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh † p < 0,001
English: For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics.
Slovenian: Za otroke, ki ne morejo pogoltniti tablet, prosimo, glejte povzetek glavnih značilnosti zdravila za peroralno raztopino zdravila Kaletra.
English: Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by lopinavir/ritonavir.
Slovenian: Zaradi BCRP (proteina odpornosti proti raku dojke/ABCG2) in akutnega zavrtja P-gp z lopinavirjem/ritonavirjem.
English: If you or your child stop taking Kaletra
Slovenian: Če ste vi ali vaš otrok prenehali jemati zdravilo Kaletra
English: fluvastatin or pravastatin is recommended.
Slovenian: sta priporočljiva pravastatin ali fluvastatin.
English: The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
Slovenian: Mediana EC50 lopinavirja proti izolatom z 0-3, 4-5, 6-7 oz. 8-10 mutacijami na omenjenih aminokislinskih položajih je bila 0,8-, 2,7-, 13,5- oz. 44,0-krat večja kot EC50 proti divjemu tipu HIV.
English: • People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS.
Slovenian: - Osebe, ki jemljejo zdravilo Kaletra, lahko še vedno zbolijo za okužbami ali drugimi boleznimi, povezanimi z boleznijo HIV in AIDS-om.
English: − If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Methadone
Slovenian: Metadon
English: Concomitant administration of Kaletra and alfuzosin is contraindicated (see section 4.3) as alfuzosin-related toxicity, including hypotension, may be increased.
Slovenian: Sočasna uporaba zdravila Kaletra in alfuzosina je kontraindicirana (glejte poglavje 4.3), ker se lahko poveča z alfuzosinom povezana toksičnost, vključno s hipotenzijo.
English: Modest decreases in amprenavir activity were noted with a median increase of IC50 from 3.7- to 8-fold in the baseline and rebound isolates, respectively.
Slovenian: Ugotovili so zmerno zmanjšano aktivnost amprenavirja s srednjim (mediana) povečanjem IC50 od 3,7-krat izhodiščno do 8krat z izolati po preobratu.
English: Concomitant use of avanafil or vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba avanafila ali vardenafila in lopinavirja/ritonavirja je kontraindicirana (glejte poglavje 4.3).
English: Co-administration of ibrutinib and Kaletra may increase ibrutinib exposure which may increase the risk of toxicity including risk of tumor lysis syndrome.
Slovenian: Sočasna uporaba ibrutiniba in zdravila Kaletra lahko poveča izpostavljenost ibrutinibu, kar lahko poveča tveganje za toksičnost, vključno s tveganjem za pojav sindroma tumorske lize.
English: • pain-relieving medicines (e.g. fentanyl);
Slovenian: - zdravila za lajšanje bolečine (npr. fentanil);
English: Place the tip of the syringe into the liquid.
Slovenian: Konico brizge potopite v tekočino.
English: ≥ 1.2 to < 1.4
Slovenian: ≥ 1,2 do < 1,4
English: Kaletra tablets have also shown less pharmacokinetic variability under all meal conditions compared to Kaletra soft capsules.
Slovenian: Prav tako je bila farmakokinetična variabilnost med uporabo tablet zdravila Kaletra ne glede na vrsto obroka hrane manjša kot med uporabo mehkih kapsul zdravila Kaletra.
English: Table 5
Slovenian: Preglednica 5
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3.
Slovenian: Interval QTcF so ocenili v randomizirani, s placebom in zdravilno učinkovino (moksifloksacin 400 mg enkrat na dan) kontrolirani navzkrižni študiji pri 39 zdravih odraslih, ki so jim 3. dan v 12 urah naredili 10 meritev.
English: One-hundred thirteen nelfinavir-treated patients and 74 lopinavir/ritonavir-treated patients had an HIV RNA above 400 copies/ml while on treatment from Week 24 through Week 96.
Slovenian: 113 bolnikov, zdravljenih z nelfinavirjem in 74 bolnikov, zdravljenih z lopinavirjem/ritonavirjem je imelo HIV RNA nad 400 kopij/ml, medtem ko so prejemali zdravljenje od 24. tedna do 96. tedna.
English: Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse reactions.
Slovenian: Zdravilo Kaletra lahko dejansko zveča koncentracijo hkrati uporabljenih zdravil, to pa lahko zveča njihove neželene kardialne učinke.
English: Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5).
Slovenian: Možnost za resne in/ali življenjsko ogrožajoče reakcije pri bolnikih z okvaro ledvic in/ali jeter (glejte poglavji 4.4 in 4.5).
English: The lopinavir mean ± standard deviation steady-state AUC, Cmax and C12 were 112.5 ± 37.1 μg•h/ml, 12.4 ± 3.5 μg/ml and 5.71 ± 2.99 μg/ml, respectively.
Slovenian: Povprečne AUC, Cmax in C12 ± standardne deviacije v stanju dinamičnega ravnovesja lopinavirja so bile 112.5 ± 37.1 μg•h/ml, 12.4 ± 3.5 μg/ml in 5.71 ± 2.99 μg/ml.
English: The 2 bottle pack also contains two 2 ml syringes with 0.1 ml graduations.
Slovenian: Pakiranje z 2 plastenkama vsebuje dve 2 ml brizgi z 0,1 ml oznakami.
English: Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Slovenian: Ker je Kaletra v veliki meri vezana na beljakovine, ni verjetno, da bi dializa pomembno odstranila zdravilno učinkovino.
English: Paediatric dosing guidelines without concomitant efavirenz or nevirapine*
Slovenian: Smernice za pediatrično odmerjanje brez sočasnega efavirenza ali nevirapina*
English: The standard recommended dosage of Kaletra tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food.
Slovenian: Standardni priporočeni odmerek tablet zdravila Kaletra je 400/100 mg (dve 200/50 mg tableti) dvakrat na dan, zaužito s hrano ali brez nje.
English: 40 film-coated tablets.
Slovenian: 40 filmsko obloženih tablet.
English: In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
Slovenian: V odsotnosti človeškega seruma je bila povprečna IC50 lopinavirja proti petim različnim laboratorijskim sevom HIV-1 19 nM.
English: 0.7 ml (57.5/14.4 mg) 1.2 ml (96/24 mg) 1.4 ml (115/28.8 mg) 2.2 ml (172.5/43.1 mg) 2.3 ml (184/46 mg) 2.9 ml (230/57.5 mg) 3.6 ml (287.5/71.9 mg) 3.7 ml (299/74.8 mg) 4.0 ml (322/80.5 mg) 4.3 ml (345/86.3 mg) 5 ml (402.5/100.6 mg) *Body surface area can be calculated with the following equation BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Slovenian: 1,4 ml (115/28,8 mg) 2,2 ml (172,5/43,1 mg) 2,3 ml (184/46 mg) 2,9 ml (230/57,5 mg) 3,6 ml (287,5/71,9 mg) 3,7 ml (299/74,8 mg) 4,0 ml (322/80,5 mg) 4,3 ml (345/86,3 mg) 5 ml (402,5/100,6 mg)
English: The following events have been reported in association with unintended overdoses in preterm neonates: complete atrioventricular block, cardiomyopathy, lactic acidosis, and acute renal failure.
Slovenian: V primerih naključnega prevelikega odmerjanja pri nedonošenih novorojenčkih so bili opisani naslednji učinki: popolni atrioventrikularni blok, kardiomiopatija, laktacidoza in akutna odpoved ledvic.
English: Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
Slovenian: Nespremenjeni lopinavir predstavlja v urinu približno 2,2 %, v blatu pa približno 19,8% uporabljenega odmerka.
English: Analysis of resistance in ARV-naïve patients
Slovenian: Analiza odpornosti pri bolnikih, naivnih za protiretrovirusna zdravila
English: Lopinavir/ritonavir plasma concentrations may decrease due to CYP3A4 induction by bosentan.
Slovenian: Koncentracija lopinavirja/ritonavirja v plazmi se lahko zniža zaradi indukcije CYP3A4 z bosentanom.
English: ** n = 16 for Cpredose
Slovenian: ** n = 16 za Cpred odmerkom
English: Co-administration of Kaletra with rifampicin is not recommended as the decrease in lopinavir concentrations may in turn significantly decrease the lopinavir therapeutic effect.
Slovenian: Sočasna uporaba zdravila Kaletra in rifampicina ni priporočljiva, kajti znižanje koncentracije lopinavirja lahko bistveno zmanjša terapevtski učinek lopinavirja.
English: Side effects where frequency is not known:
Slovenian: Neželeni učinki z neznano pogostnostjo:
English: Bepridil, Systemic Lidocaine, and Quinidine
Slovenian: Bepridil, sistemski lidokain in kinidin
English: Antihistamines
Slovenian: Antihistaminiki
English: Kaletra is recommended for use in adults and children 14 days of age and older who are infected with HIV.
Slovenian: Zdravilo Kaletra je priporočeno za uporabo pri odraslih in otrocih, starih 14 dni in več, okuženih s HIV.
English: When used for osteoarticular infections, where the coadministration is unavoidable, close clinical monitoring for muscular adverse events is strongly recommended (see section 4.4).
Slovenian: V primeru uporabe za osteoartikularne okužbe, pri katerih se sočasni uporabi ni mogoče izogniti, je zelo priporočljiv natančen klinični nadzor glede neželenih učinkov na mišice (glejte poglavje 4.4).
English: 120 film-coated tablets
Slovenian: 120 filmsko obloženih tablet
English: Data from clinical trials in children below 2 years of age include the pharmacokinetics of Kaletra 300/75 mg/m2 twice daily studied in a total of 31 paediatric patients, ranging in age from 14 days to 6 months.
Slovenian: Podatki iz kliničnih preskušanj pri otrocih, mlajših od 2 let, vključujejo farmakokinetiko zdravila Kaletra 300/75 mg/m2 dvakrat na dan, ki je bila raziskana pri skupaj 31 pediatričnih bolnikih, starih od 14 dni do 6 mesecev.
English: Outcomes at Week 48: Study M98-863 Kaletra (N=326)
Slovenian: Rezultati v 48. tednu: Študija M98-863 Kaletra (N=326)
English: • sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery).
Slovenian: - sildenafil - uporablja se za zdravljenje pljučne arterijske hipertenzije (visok krvni tlak v pljučni arteriji).
English: Furthermore, polyoxol 40 hydrogenated castor oil and potassium present in Kaletra oral solution may cause only at high inadvertent doses gastrointestinal upset.
Slovenian: Poleg tega lahko makrogolglicerol hidroksistearat 40 in kalij, ki ju vsebuje peroralna raztopina zdravila Kaletra, le v velikih, nenamernih odmerkih povzročita prebavne motnje.
English: Sofosbuvir/velpatasvir/ voxilaprevir
Slovenian: Sofosbuvir/velpatasvir/ voksilaprevir
English: 60 ml oral solution
Slovenian: 60 ml peroralne raztopine
English: • Kaletra must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.
Slovenian: - V primeru uporabe enkrat na dan se zdravila Kaletra ne sme jemati z efavirenzem, nevirapinom, karbamazepinom, fenobarbitalom ali fenitoinom.
English: In addition, virologic response was observed in 91% (21/23), 71% (15/21) and 33% (2/6) patients with 0 − 5, 6 − 7, and 8 − 10 mutations of the above mutations in HIV protease associated with reduced in vitro susceptibility to lopinavir.
Slovenian: Poleg tega so virološki odziv opažali pri 91 % (21/23), 71 % (15/21) oz. 33 % (2/6) bolnikov z 0-5, 6-7 oz. 8-10
English: (25/150/100 mg QD)
Slovenian: (25/150/100 mg enkrat na dan)
English: Kaletra oral solution is contraindicated in children below the age of 14 days, pregnant women, patients with hepatic or renal failure and patients treated with disulfiram or metronidazole due to the potential risk of toxicity from the excipient propylene glycol (see section 4.4).
Slovenian: Kaletra kontraindicirana pri otrocih, mlajših od 14 dni, nosečnicah, bolnikih z odpovedjo jeter ali ledvic in pri bolnikih, zdravljenih z disulfiramom ali metronidazolom (glejte poglavje 4.4).
English: • vomiting, enlarged abdomen, pain in the lower and upper stomach area, passing wind, indigestion, decreased appetite, reflux from your stomach to your oesophagus which may cause pain;
Slovenian: - bruhanje, povečan trebuh, bolečine v spodnjem in zgornjem delu trebuha, vetrovi, prebavne motnje, zmanjšan apetit, refluks iz želodca v požiralnik, ki je lahko boleč;
English: Through Week 48, genotypic resistance testing results were available from 75 patients in the QD group and 75 patients in the BID group who had incomplete virologic response.
Slovenian: V 48. tednu so bili na voljo rezultati testiranja genotipske odpornosti za 75 bolnikov v skupini, ki je prejemala zdravilo 1 x dnevno, in za 75 bolnikov v skupini, ki je prejemala zdravilo 2 x dnevno in ki je imela nepopoln virološki odgovor.
English: Cmax Cpredose μg /mL
Slovenian: Cmax Cpred odmerkom μg /ml
English: It should not be given when intestinal obstruction is present.
Slovenian: Ne sme se uporabljati v primeru obstrukcije črevesa.
English: Ergot alkaloids
Slovenian: Alkaloidi ergot
English: The dose of Kaletra may need adjusting.
Slovenian: Potrebna je lahko prilagoditev odmerka zdravila Kaletra.
English: You must not take Kaletra with colchicine if you have kidney and/or liver problems (see also ‘Do not take Kaletra' above);
Slovenian: Zdravila Kaletra ne smete jemati skupaj s kolhicinom, če imate težave z ledvicami in/ali jetri (glejte tudi ‘Ne jemljite zdravila Kaletra'
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures
Slovenian: Srednje povečanje števila T-celic CD4 od začetka (celic/mm3) *analiza z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh
English: • inflammation of the first section of the small intestine just after the stomach, wound or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
Slovenian: - vnetje prvega dela tankega črevesa takoj za želodcem, rana ali razjeda v prebavilih, krvavitev iz prebavil ali rektuma;
English: − If you notice you miss a dose within 12 hours of your normal dosing time, take your missed dose as soon as possible, and then continue with your normal dose at the regular time as prescribed by your doctor.
Slovenian: Če opazite, da ste pozabili vzeti odmerek zdravila v 12 urah od predvidenega časa jemanja, vzemite izpuščeni odmerek čim prej in nato nadaljujte z odmerjanjem kot običajno, kakor vam je predpisal zdravnik.
English: Analgesics Fentanyl
Slovenian: Analgetiki Fentanil
English: − If you notice you miss a dose within 6 hours of your normal dosing time, take your missed dose as soon as possible, and then continue with your normal dose at the regular time as prescribed by your doctor.
Slovenian: Če opazite, da ste pozabili vzeti odmerek zdravila v 6 urah od predvidenega časa jemanja, vzemite izpuščeni odmerek čim prej in nato nadaljujte z odmerjanjem kot običajno, kakor vam je predpisal zdravnik.
English: KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
Slovenian: (celic/mm3) KONCERT/PENTA 18 je prospektivna, multicentrična, randomizirana, odprta študija, ki je ocenila farmakokinetični profil, učinkovitost in varnost odmerjanja dvakrat na dan napram enkrat na dan za kombinacijo lopinavir/ritonavir 100 mg/25 mg tablete; odmerjane glede na maso kot del kombiniranega protiretrovirusnega zdravljenja (cART - combination antiretroviral therapy) pri virološko suprimiranih otrocih, okuženih s HIV-1 (n=173).
English: Etravirine:
Slovenian: Etravirin:
English: Administration of Kaletra with a high fat meal (872 kcal, 55.8% from fat) increased lopinavir AUC and Cmax by 96% and 43%, respectively, for soft capsules, and 130% and 56%, respectively, for oral solution.
Slovenian: Uporaba zdravila Kaletra z zelo mastnim obrokom (872 kcal, 55,8 % iz maščob) je zvečala AUC oz. Cmax mehkih kapsul za 96 % oz. 43 %, peroralne raztopine pa za 130 % oz. 56 %.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Slovenian: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V in L90M.
English: The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Slovenian: Vključena populacija je bila zmerno izkušena z zaviralci proteaz: več kot polovica bolnikov ni še nikoli prej dobivalo zaviralce proteaz in približno 80
English: Lopinavir AUC over a 12 hour dosing interval averaged 113.2 ± 60.5 µg•h/ml.
Slovenian: AUC lopinavirja med 12 urnim odmernim intervalom je bila v povprečju 113,2 ± 60,5 µg•h/ml.
English: Amprenavir concentrations are significantly reduced.
Slovenian: Fosamprenavir: koncentracija amprenavirja se bistveno zniža.
English: Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5).
Slovenian: Povečano tveganje za sindrom tumorske lize pri začetnem odmerjanju in med fazo povečevanja odmerka (glejte poglavje 4.5).
English: PDE5 inhibitors
Slovenian: Zaviralci PDE5
English: Colchicine:
Slovenian: Kolhicin:
English: Reduced serum thyroxin led to an increased release of TSH with resultant follicular cell hypertrophy in the thyroid glands of rats.
Slovenian: Znižanje tiroksina v serumu je pri podganah povzročilo zvečano sproščanje TSH in posledično hipertrofijo folikelskih celic v ščitnici.
English: Cushing's syndrome has been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide (see section 4.4 and 4.5).
Slovenian: Pri bolnikih, ki so prejemali ritonavir in inhalacijsko ali intranazalno uporabljen flutikazon propionat, so poročali o Cushingovem sindromu; ta se lahko pojavi tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo preko poti P450 3A, npr. budenozid (glejte poglavji 4.4 in 4.5).
English: The most common adverse reactions related to Kaletra therapy during clinical trials were diarrhoea, nausea, vomiting, hypertriglyceridaemia and hypercholesterolemia.
Slovenian: Najpogostejši neželeni učinki, povezani z zdravljenjem z zdravilom Kaletra, v kliničnih študijah, so bili driska, slabost, bruhanje, hipertrigliceridemija in hiperholesterolemija.
English: Patients with prior antiretroviral therapy
Slovenian: Bolniki s predhodnim protiretrovirusnim zdravljenjem
English: Herbal preparations containing St John's wort must not be combined with lopinavir and ritonavir.
Slovenian: Zeliščnih pripravkov s šentjanževko se ne sme kombinirati z lopinavirjem in ritonavirjem.
English: Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely.
Slovenian: Ne vozite in ne upravljajte s stroji, če se vam pojavi katerikoli neželeni učinek (npr.
English: Children less than 2 years of age
Slovenian: Otroci, mlajši od 14 dni in nedonošenčki
English: − Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
Slovenian: - zdravniku povejte, če vam je slabo, bruhate ali vas boli trebuh, ker bi to lahko kazalo na pankreatitis (vnetje trebušne slinavke);
English: Multipack: 120 (3 packs of 40) film-coated tablets 120 film-coated tablets
Slovenian: Multipakiranje: 120 (3 pakiranja s 40) filmsko obloženih tablet 120 filmsko obloženih tablet
English: These increases of plasma concentrations of co-administered medicinal products could increase or prolong their therapeutic effect and adverse events (see sections 4.3 and
Slovenian: Zvečana koncentracija sočasno uporabljenih zdravil v plazmi lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke (glejte poglavji 4.3 in 4.5).
English: After 48 weeks of treatment with Kaletra, efavirenz and nucleoside reverse transcriptase inhibitors, plasma HIV RNA ≤ 400 copies/ml was observed in 93% (25/27), 73% (11/15), and 25% (2/8) of patients with < 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
Slovenian: Po 48 tednih zdravljenja z zdravilom Kaletra, efavirenzem in nukleozidnimi zaviralci reverzne transkriptaze so HIV RNA v plazmi ≤ 400 kopij/ml ugotovili pri 93 % (25/27), 73% (11/15), in 25 % (2/8) bolnikov z < 10
English: For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions).
Slovenian: Za bolnike, ki so zaključili fazo povečevanja odmerka in prejemajo stalen dnevni odmerek venetoklaksa, zmanjšajte odmerek venetoklaksa za najmanj 75 %,
English: Concomitant use of Kaletra with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Slovenian: Sočasna uporaba zdravila Kaletra z lomitapidom je kontraindicirana (glejte informacije o predpisovanju za lomitapid) (glejte poglavje 4.3).
English: Lopinavir is extensively metabolised by the hepatic cytochrome P450 system, almost exclusively by isozyme CYP3A.
Slovenian: Lopinavir se izdatno presnavlja s sistemom jetrnega citokroma P450, skoraj izključno z izoencimom CYP3A.
English: A more pronounced effect on DM-6705 exposure may be observed during prolonged coadministration with lopinavir/ritonavir.
Slovenian: AUC: ↑ 30 % Bolj izrazit učinek na izpostavljenost DM-6705 se lahko opazi med podaljšano sočasno uporabo z lopinavirjem/ritonavirjem.
English: • Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
Slovenian: - Zdravnik vam je predpisal zdravilo Kaletra za obvladovanje okužbe z virusom humane imunopomanjkljivosti (HIV).
English: If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring.
Slovenian: Če je uporaba atorvastatina res potrebna, je treba uporabiti najmanjši možni odmerek atorvastatina in potrebno je natančno varnostno spremljanje
English: At entry, median age was 0.7 years, median CD4 T-cell count was 1147 cells/mm3, median CD4 T-cell was 19%, and median HIV-1 RNA was > 750,000 copies/ml.
Slovenian: Ob vključitvi je bila mediana starosti 0,7 leta, mediana števila T-celic CD4 1147 celic/mm3, mediana deleža T-celic CD4 19 % in mediana HIV-1 RNA > 750,000 kopij/ml.
English: The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 µg/ml.
Slovenian: Povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja pred jutranjim odmerkom je bila 8,1 ± 5,7 µg/ml.
English: Read the list of medicines below under ‘Other medicines and Kaletra' for information on certain other medicines which require special care.
Slovenian: Za informacije o drugih zdravilih, ki zahtevajo posebno pozornost, preberite seznam zdravil spodaj v poglavju “Druga zdravila in zdravilo Kaletra”.