FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult patients who have previously taken other antiviral medicines can take Kaletra tablets once daily as an 800 mg/200 mg dose if their doctor decides it is appropriate.
Slovenian: Odrasli bolniki, ki so predhodno dobivali druga protiretrovirusna zdravila, lahko tablete zdravila Kaletra jemljejo enkrat na dan v odmerku 800 mg/200 mg, če njihov zdravnik presodi, da je to primerno.
English: Concomitant Therapy: Efavirenz or Nevirapine
Slovenian: Sočasna zdravila: efavirenz ali nevirapin
English: Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects.
Slovenian: Ugotovljeno je, da kombinacija lopinavir/ritonavir nekaterim zdravim odraslim osebam zmerno in asimptomatsko podaljša interval PR.
English: In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2).
Slovenian: Pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaro so opazili za približno 30% večjo izpostavljenost lopinavirju, vendar ni pričakovati, da bi to bilo klinično pomembno (glejte poglavje
English: • Diabetes as increased blood sugars has been reported in patients receiving Kaletra.
Slovenian: - sladkorno bolezen, ker so pri bolnikih, ki so jemali zdravilo Kaletra, poročali o zvišanem krvnem sladkorju.
English: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Slovenian: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, Velika Britanija AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska AbbVie Deutschland GmbH & Co.
English: Through Week 96, genotypic resistance testing results were available from 25 patients in the QD group and 26 patients in the BID group who had incomplete virologic response.
Slovenian: V 96.tednu so bili rezultati testiranja genotipske odpornosti na voljo za 25 bolnikov v skupini, ki je jemala zdravilo 1 x dnevno in 26 bolnikov v skupini, ki je jemala zdravila 2 x dnevno in ki je imela nepopoln virološki odgovor.
English: Sixty-one patients completed the study (35 patients received the recommended 400/100 mg twice daily dose throughout the study).
Slovenian: Študijo je dokončalo 61 bolnikov (35 bolnikov je ves čas študije dobivalo priporočeni odmerek 400/100 mg dvakrat na dan).
English: Patients were randomised in a 1:1 ratio to receive either Kaletra 800/200 mg once daily (n = 333) or Kaletra 400/100 mg twice daily (n = 331).
Slovenian: Bolniki so bili v razmerju 1:1 randomizirani na zdravljenje z zdravilom Kaletra 800/200 mg enkrat na dan (n = 333) ali zdravilo Kaletra 400/100 mg dvakrat na dan (n = 331).
English: Antianginal Ranolazine
Slovenian: Antianginozna zdravila Ranolazin
English: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: • If the dose is between 2 ml and 5 ml - use the 5 ml oral dosing syringe to prepare a dose.
Slovenian: - Če je odmerek med 2 ml in 5 ml, za pripravo odmerka uporabite 5 ml brizgo za peroralno dajanje.
English: Concomitant medicinal product levels increased Alpha1-adrenoreceptor antagonist
Slovenian: Zvišanje koncentracije sočasno uporabljenih zdravil Zaviralec adrenergičnih receptorjev alfa1
English: Due to P-gp and/or CYP3A4 inhibition by ritonavir.
Slovenian: Zaradi zavrtja P-gp in/ali CYP3A4 z ritonavirjem.
English: Increased risk of alanine transaminase (ALT) elevations (see section 4.5).
Slovenian: Povečano tveganje za povišanje alanin transaminaze (ALT) (glejte poglavje 4.5).
English: Administration of a single 400/100 mg dose of Kaletra tablets under fed conditions (high fat, 872 kcal, 56% from fat) compared to fasted state was associated with no significant changes in Cmax and AUCinf.
Slovenian: Uporabe posamičnega odmerka 400/100 mg tablet zdravila Kaletra na poln želodec (z mastnim obrokom, 872 kcal, 56 % iz maščob) v primerjavi z uporabo na tešče ni spremljala pomembna sprememba Cmax in AUCinf.
English: • Kaletra is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Slovenian: - Zdravilo Kaletra se uporablja pri otrocih, starih 2 leti ali več, mladostnikih in odraslih, okuženih s HIV, virusom, ki povzroča AIDS.
English: Ritonavir is a potent CYP3A inhibitor which inhibits the metabolism of lopinavir and therefore, increases plasma levels of lopinavir.
Slovenian: Ritonavir je močan zaviralec CYP3A, zavira presnovo lopinavirja in tako zvečuje koncentracijo lopinavirja v plazmi.
English: In the QD group, no patient demonstrated lopinavir resistance, and in the BID group, 1 patient who had significant protease inhibitor resistance at baseline demonstrated additional lopinavir resistance on study.
Slovenian: V skupini, ki je jemala zdravilo 1 x dnevno, ni noben bolnik pokazal odpornosti proti lopinavirju, v skupini, ki je jemala zdravilo 2 x dnevno, pa je 1 bolnik, ki je imel v začetku pomembno odpornost proti zaviralcem proteaze, pokazal dodatno odpornost proti lopinavirju med študijo.
English: After a 400/100 mg 14C-lopinavir/ritonavir dose, approximately 10.4 ± 2.3% and 82.6 ± 2.5% of an administered dose of 14C-lopinavir can be accounted for in urine and faeces, respectively.
Slovenian: Po odmerku 400/100 mg 14C-lopinavirja/ritonavirja se v urinu izloči približno 10,4 ± 2,3 % uporabljenega odmerka 14C-lopinavirja in v blatu 82,6 ± 2,5 %.
English: Kaletra must not be administered once daily in combination with carbamazepine and phenobarbital.
Slovenian: Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji s karbamazepinom in fenobarbitalom.
English: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: • lovastatin, simvastatin (used to lower blood cholesterol);
Slovenian: - lovastatin, simvastatin (uporabljata se za zniževanje ravni holesterola v krvi); - lomitapid (uporablja se za zniževanje ravni holesterola v krvi);
English: Anti-infectives Fusidic acid
Slovenian: Antiinfektivi Fusidna kislina
English: When co-administered with carbamazepine or phenobarbital, an increase of Kaletra dosage may be envisaged.
Slovenian: Med sočasno uporabo s karbamazepinom ali fenobarbitalom je treba predvideti povečanje odmerka zdravila
English: Concomitant administration of Kaletra and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3).
Slovenian: Sočasna uporaba zdravila Kaletra in ergot alkaloidov je kontraindicirana, saj lahko vodi v akutno ergot toksičnost, vključno z vazospazmom in ishemijo (glejte poglavje 4.3).
English: Tenofovir disoproxil fumarate (DF), 300 mg QD
Slovenian: Dizoproksiltenofovirijev fumarat (DF), 300 mg enkrat na dan
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Kaletra Vsebina pakiranja in dodatne informacije
English: • No dose adjustment is required for lopinavir/ritonavir during pregnancy and postpartum.
Slovenian: • Med nosečnostjo in po porodu ni potrebna prilagoditev odmerka lopinavirja/ritonavirja.
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Slovenian: KG, Knollstrasse, 67061 Ludwigshafen, Nemčija
English: Put the syringe back together and draw up and expel tap water a few times to rinse.
Slovenian: Brizgo nato spet sestavite ter vanjo oz. iz nje nekajkrat potegnite oz. iztisnite navadno vodo, da jo boste splaknili.
English: Weight (kg)
Slovenian: Telesna masa (kg)
English: Read the list of medicines above ‘Do not take Kaletra with any of the following medicines' for information on medicines that you must not take with Kaletra.
Slovenian: Za informacije o zdravilih, ki jih ne smete jemati skupaj z zdravilom Kaletra, preberite seznam zdravil zgoraj v poglavju “Ne jemljite zdravila Kaletra, če trenutno jemljete katero od naslednjih zdravil”.
English: • increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood, high blood pressure;
Slovenian: - otekanje ali vnetje želodca, črevesja in debelega črevesa; - povišan nivo holesterola v krvi, povišan nivo trigliceridov (oblika maščobe) v krvi, visok krvni tlak;
English: Observed data
Slovenian: Zabeleženi podatki
English: • eye disorder, abnormal vision;
Slovenian: - bolezni oči, nenormalen vid;
English: Using the 2 ml oral dosing syringe for doses up to 2 ml
Slovenian: Uporaba 2 ml brizge za peroralno dajanje za odmerke do 2 ml
English: Administration of a single 400/100 mg dose of Kaletra soft capsules with a moderate fat meal (500 - 682 kcal, 22.7 -25.1% from fat) was associated with a mean increase of 48% and 23% in lopinavir AUC and Cmax, respectively, relative to fasting.
Slovenian: Uporaba posameznega odmerka 400/100 mg mehkih kapsul zdravila Kaletra z zmerno mastnim obrokom (500-682 kcal, 22,7 % do 25,1 % iz maščob) je bila povezana s povprečnim zvečanjem AUC lopinavirja za 48 % in Cmax za 23 % v primerjavi z uporabo na tešče.
English: To date, there is limited human experience of acute overdose with Kaletra.
Slovenian: Izkušnje z akutnim prevelikim odmerjanjem zdravila Kaletra pri ljudeh so doslej omejene.
English: Let the syringe dry completely before you use that syringe for dosing.
Slovenian: Preden to isto brizgo znova uporabite za odmerjanje, jo morate pustiti, da se popolnoma posuši.
English: Blister multipacks containing 120 tablets (1 pack of 120 tablets or 3 packs each containing 40 tablets) are also available.
Slovenian: Na voljo so tudi multipakiranja s 120 tabletami v pretisnih omotih (1 pakiranje s 120 tabletami ali 3 pakiranja, od katerih vsako vsebuje 40 tablet).
English: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Slovenian: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Velika Britanija AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska AbbVie Deutschland GmbH & Co.
English: HCV protease inhibitors Simeprevir 200 mg daily (ritonavir 100 mg BID)
Slovenian: Zaviralci proteaze HCV Simeprevir 200 mg/dan (ritonavir 100 mg dvakrat na dan)
English: Kaletra is not a cure for HIV infection or AIDS.
Slovenian: Zdravilo Kaletra ne ozdravi okužbe s HIV ali aidsa.
English: ≥ 0.5 to < 0.9
Slovenian: ≥ 0,5 do < 0,9
English: Beta2-adrenoceptor agonist (long acting) Salmeterol
Slovenian: Agonisti adrenergičnih receptorjev beta2 (dolgodelujoči)
English: Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Slovenian: Povečana koncentracija paritaprevirja v plazmi; zato je povečano tveganje za povišanja alanin transaminaze (ALT) (glejte poglavje 4.5).
English: Blisters packs - polyvinyl chloride (PVC) blisters with fluoropolymer foil backing Two pack sizes are available: - carton containing 120 film-coated tablets - multipack containing 120 (3 cartons of 40) film-coated tablets
Slovenian: Pakiranja pretisnih omotov - pretisni omoti iz polivinilklorida (PVC) s folijo iz fluoropolimera Na trgu sta dve pakiranji: - škatla, ki vsebuje 120 filmsko obloženih tablet - multipakiranje, ki vsebuje 120 (3 škatle po 40) filmsko obloženih tablet
English: Two pack sizes are available for Kaletra oral solution: - 120 ml (2 bottles x 60 ml) with 2 x 2 ml syringes with 0.1 ml graduations
Slovenian: Na voljo sta dve velikosti pakiranja zdravila Kaletra peroralna raztopina: - 120 ml (2 plastenki po 60 ml) z dvema 2 ml brizgama z 0,1 ml oznakami.
English: Push the plunger all of the way into the barrel.
Slovenian: Bat potisnite do konca cevi.
English: Serum concentrations of sofosbuvir, velpatasvir and voxilaprevir may be increased due to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir.
Slovenian: Serumske koncentracije sofosbuvirja, velpatasvirja in voksilaprevirja se lahko zvišajo zaradi zavrtja P-glikoproteina, BCRP in OATP1B1/3 z lopinavirjem/ritonavirjem.
English: More frequent therapeutic concentration monitoring is recommended until plasma levels of these products have been stabilised.
Slovenian: Dokler se koncentracija teh zdravil v plazmi ne stabilizira, je priporočljivo pogosteje kontrolirati terapevtsko koncentracijo.
English: ≥ 0.5 to < 0.8
Slovenian: ≥ 0,5 do < 0,8
English: Kaletra film-coated tablets are supplied in packs containing 120 tablets (1 plastic bottle of 120 tablets) and multipacks comprising 3 plastic bottles each containing 120 tablets (360 tablets).
Slovenian: Zdravilo Kaletra filmsko obložene tablete so na voljo v pakiranju, ki vsebuje 120 tablet (1 plastenka s 120 tabletami) in multipakiranju, ki vsebuje 3 plastenke, od katerih vsaka vsebuje 120 tablet (360 tablet).
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Slovenian: Kombinacija lahko poveča tveganje za srčno-žilne neželene učinke, povezane s salmeterolom, vključno s podaljšanjem QT,
English: • Kaletra is prescribed for use in combination with other antiviral medicines.
Slovenian: Zdravilo Kaletra se uporablja v kombinaciji z drugimi protivirusnimi zdravili.
English: (25/150/100 mg QD + 400 mg BID)
Slovenian: (25/150/100 mg enkrat na dan + 400 mg 2x dnevno)
English: − medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
Slovenian: zdravila za urejanje srčnega ritma (npr. bepridil, sistemski lidokain, kinidin);
English: Bottle containing 60 film-coated tablets.
Slovenian: Plastenka vsebuje 60 filmsko obloženih tablet.
English: Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Slovenian: občasni hepatična steatoza, hepatomegalija, holangitis, hiperbilirubinemija neznana pogostnost zlatenica
English: Modest prolongation of the PR interval was also noted in subjects receiving lopinavir/ritonavir in the same study on Day 3.
Slovenian: Med preiskovanci, ki so dobivali lopinavir/ritonavir, so v isti študiji 3. dan ugotovili zmerno podaljšanje intervala PR.
English: Rilpivirine:
Slovenian: Rilpivirin:
English: Therefore, Kaletra tablets may be taken with or without food.
Slovenian: Tablete zdravila Kaletra lahko torej bolnik vzame s hrano ali brez nje.
English: • 300 ml (5 bottles x 60 ml).
Slovenian: - 300 ml (5 plastenk po 60 ml).
English: The following table contains dosing guidelines for Kaletra 100/25 mg tablets based on body weight and BSA.
Slovenian: Naslednja tabela prikazuje smernice za odmerjanje tablet zdravila Kaletra 100/25 mg glede na telesno maso in telesno površino.
English: Increased plasma concentrations of astemizole and terfenadine.
Slovenian: Večja koncentracija astemizola in terfenadina v plazmi.
English: Renal Insufficiency
Slovenian: Jetrna insuficienca
English: The recommended dosage of Kaletra is 5 ml of oral solution (400/100 mg) twice daily taken with food.
Slovenian: Priporočeni odmerek zdravila Kaletra je 5 ml peroralne raztopine (400/100 mg) dvakrat na dan, zaužite s hrano.
English: Anticancer
Slovenian: Zdravila proti raku
English: • bone death caused by poor blood supply to the area;
Slovenian: - zmanjšana želja po spolnosti; - vnetje ledvic; - odmrtje kosti zaradi slabe preskrbe s krvjo v to področje;
English: 60 film-coated tablets
Slovenian: 60 filmsko obloženih tablet
English: Fosamprenavir (1400 mg BID)
Slovenian: Fosamprenavir (1400 mg dvakrat na dan)
English: - 300 ml (5 bottles x 60 ml) with 5 x 5 ml syringes with 0.1 ml graduations
Slovenian: - 300 ml (5 plastenk po 60 ml) s petimi 5 ml brizgami z 0,1 ml oznakami.
English: Concomitant use of Kaletra with apalutamide is not recommended.
Slovenian: Sočasna uporaba zdravila Kaletra z apalutamidom ni priporočljiva.
English: Kaletra tablets can be taken with or without food.
Slovenian: - Zdravilo Kaletra tablete se lahko jemlje s hrano ali brez nje.
English: Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia (see section 4.5).
Slovenian: Večja koncentracija derivatov ergot, ki povzroči akutno ergotsko toksičnost, vključno z vazospazmom in ishemijo (glejte poglavje 4.5).
English: Antiviral activity of Kaletra in patients failing protease inhibitor therapy The clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to Kaletra therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Slovenian: Klinični pomen zmanjšane občutljivosti za lopinavir in vitro so raziskali z oceno virološkega odziva na zdravljenje z zdravilom Kaletra (upoštevaje izhodiščni virusni genotip in fenotip) pri 56 bolnikih s predhodno neuspešnim zdravljenjem z več zaviralci proteaz.
English: Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Slovenian: Študija M98-863 je randomizirano, dvojno slepo preskušanje s 653 bolniki, naivnimi za protiretrovirusno zdravljenje, ki proučuje zdravilo Kaletra (400/100 mg dvakrat na dan) v primerjavi z nelfinavirjem (750 mg trikrat na dan) v kombinaciji s stavudinom in lamivudinom.
English: • colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on
Slovenian: - kolhicin (zdravilo za zdravljenje protina) - če imate težave z ledvicami in/ali jetri (glejte poglavje
English: ≥ 0.8 to < 1.2
Slovenian: ≥ 0,8 do < 1,2
English: Co-administration of Kaletra with these medicinal products is expected to substantially increase their concentrations and may result in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see section 4.5).
Slovenian: Kaletra in teh zdravil bistveno zviša njihovo koncentracijo in lahko povzroči spremljajoče neželene učinke, npr. hipotenzijo, sinkopo, motnje vida in dolgotrajno erekcijo (glejte poglavje 4.5).
English: Rivaroxaban:
Slovenian: Rivaroksaban:
English: The adverse reactions are displayed by system organ class.
Slovenian: Neželeni učinki so navedeni po organskih sistemih.
English: Monitor for ADRs related to abemaciclib.
Slovenian: Spremljajte neželene učinke, ki so povezani z abemaciklibom.
English: Rationale
Slovenian: Razlog
English: Kaletra oral solution contains approximately 42% v/v alcohol.
Slovenian: Peroralna raztopina zdravila Kaletra vsebuje približno 42 % v/v alkohola.
English: • A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.
Slovenian: Bolniki, ki so kdaj imeli bolezni jeter, vključno s kroničnim hepatitisom B ali C, imajo višje tveganje za hude ali potencialno usodne neželene učinke na jetrih.
English: Thyroid hormone replacement therapy Levothyroxine
Slovenian: Nadomestno zdravljenje s ščitničnimi hormoni
English: Lovastatin and Simvastatin Lovastatin, Simvastatin: Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Slovenian: Lovastatin, simvastatin: izrazito zvišanje koncentracij v plazmi zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
English: Refer to colchicine prescribing information.
Slovenian: Glejte navodila za predpisovanje kolhicina.
English: In the absence of human serum, the mean IC50 of lopinavir was 6.5 nM against several HIV-1 clinical isolates.
Slovenian: V odsotnosti človeškega seruma je bila povprečna IC50 lopinavirja proti več kliničnim izolatom HIV-1 6,5 nM.
English: Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam.
Slovenian: Peroralni midazolam, triazolam Večja koncentracija peroralnega midazolama in triazolama v plazmi.
English: Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Slovenian: Študija M05-730 je bila randomizirano, odprto multicentrično preskušanje, ki je zdravljenje z zdravilom Kaletra 800/200 mg enkrat na dan v kombinaciji s tenofovirjem DF in emtricitabinom primerjalo z zdravilom Kaletra 400/100 mg dvakrat na dan v kombinaciji s tenofovirjem DF in emtricitabinom pri 664 bolnikih, ki še niso bili deležni protiretrovirusnega zdravljenja.
English: Co-administered drug by therapeutic area
Slovenian: Sočasno uporabljena zdravila po terapevtskih področjih
English: Fusidic acid:
Slovenian: Fusidna kislina:
English: 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.
Slovenian: 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.
English: The two regimens resulted in exposures on Day 3 which were approximately 1.5 and 3-fold higher than those observed with recommended once daily or twice daily LPV/r doses at steady state.
Slovenian: Med tema režimoma uporabe je bila izpostavljenost 3. dan 1,5- oz. 3-krat večja, kot je ugotovljena med uporabo priporočenih odmerkov lopinavirja/ritonavirja enkrat oz. dvakrat na dan v stanju dinamičnega ravnovesja.
English: Multiple dosing with 400/100 mg Kaletra twice daily for 2 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 12.3 ± 5.4 µg/ml, occurring approximately 4 hours after administration.
Slovenian: Večkratno odmerjanje 400/100 mg zdravila Kaletra dvakrat na dan 2 tedna in brez omejevanja obrokov je povzročilo povprečno največjo plazemsko koncentracijo (Cmax) ± SD lopinavirja 12,3 ± 5,4 µg/ml, in sicer približno 4 ure po uporabi.
English: Lopinavir/ritonavir 800/200 mg QD was administered with ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Slovenian: Lopinavir/ritonavir 800/200 mg enkrat na dan je bil uporabljen z ombitasvirjem/paritaprevirjem/rit onavirjem z ali brez dasabuvirja.
English: d. Paediatric populations
Slovenian: Pediatrični bolniki
English: Concomitant administration with colchicine is contraindicated in patients with renal and/or hepatic impairment (see sections 4.3 and 4.5).
Slovenian: Sočasna uporaba kolhicina je kontraindicirana pri bolnikih z okvaro ledvic in/ali jeter (glejte poglavji 4.3 in 4.5).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and can occur many months after initiation of treatment (see section 4.4).
Slovenian: Čas nastopa bolezni, o katerem so poročali, je precej spremenljiv in je lahko več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures † p < 0.001
Slovenian: (celic/mm3) *analiza z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh † p < 0,001