FrancophonIA/ELRC3.0 huggingface dataset:
English: • It is important to keep Kaletra in the bottle it came in and replace the bottle cap after each dose.
Slovenian: - Pomembno je, da zdravilo Kaletra shranjujete v originalni plastenki in zaporko namestite po vsakem odmerku.
English: Delamanid (100 mg BID)
Slovenian: Delamanid (100 mg dvakrat na dan)
English: Kaletra pharmacokinetics have not been studied in older people.
Slovenian: Spol, rasa in starost Farmakokinetika zdravila Kaletra pri starejših ljudeh ni raziskana.
English: • enlargement of the lymph nodes;
Slovenian: - povečanje limfnih vozlov;
English: Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of co-administration of Kaletra and digoxin.
Slovenian: Priporočljiva je terapevtska kontrola koncentracije digoksina, če ta možnost obstaja.
English: Encorafenib
Slovenian: Enkorafenib
English: Etravirine (Lopinavir/ritonavir tablet 400/100 mg BID)
Slovenian: Etravirin (Lopinavir/ritonavir tableta 400/100 mg dvakrat na dan)
English: Ombitasvir/paritaprevir/ritonavir with or without dasabuvir
Slovenian: Ombitasvir/paritaprevir/ritonavir z ali brez dasabuvirja
English: Lopinavir/ritonavir 400/100 mg BID
Slovenian: Lopinavir/ritonavir 400/100 mg 2x dnevno
English: Antiretroviral Agents
Slovenian: Protiretrovirusna zdravila
English: • mouth sores or ulcerations, inflammation of the stomach and intestine;
Slovenian: - bolečine ali razjede v ustih, vnetje želodca in črevesa;
English: • If the dose is up to 2 ml - use the 2 ml oral dosing syringe to prepare a dose.
Slovenian: - Če je odmerek do 2 ml, za pripravo odmerka uporabite 2 ml brizgo za peroralno dajanje.
English: For smaller volumes an alternative pack is available.
Slovenian: Za volumne večje od 2 ml. Za manjše volumne je na voljo drugo pakiranje.
English: Kaletra tablets are administered orally and must be swallowed whole and not chewed, broken or crushed.
Slovenian: Tablete zdravila Kaletra se uporabljajo peroralno in jih je treba pogoltniti cele; ne sme se jih gristi, lomiti ali drobiti.
English: AUC: ↔ Cmin: ↑ 3.5-fold Cmax: ↓
Slovenian: AUC: ↔ Cmin: ↑ 3,5-krat Cmax: ↓
English: It is important to note that cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Slovenian: Omeniti je treba, da so opisani primeri pankreatitisa pri bolnikih, ki so dobivali zdravilo Kaletra,
English: Age ≥ 6 months to < 12 years cohort (N = 53):
Slovenian: Kohorta, v kateri je bila starost ≥ 6 tednov do < 6 mesecev (N = 18): Kohorta, v kateri je bila starost ≥ 6 mesecev do < 12 tednov (N = 53):
English: No dose adjustment is needed for Kaletra.
Slovenian: Za zdravilo Kaletra odmerka ni treba prilagajati.
English: This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Slovenian: To zdravilo, uporabljeno skladno z navodili za odmerjanje, vsebuje do 0,8 g fruktoze na odmerek.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Slovenian: Pri bolnikih s hemofilijo tipa A in B, zdravljenih z zaviralci proteaz, so poročali o povečanju krvavitev, vključno s spontanimi kožnimi hematomi in hemartrozami.
English: Hepatic Insufficiency
Slovenian: Ledvična insuficienca
English: • Nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the muscles in the legs and arms as these symptoms may indicate raised lactic acid levels.
Slovenian: - Siljenje na bruhanje, bruhanje, bolečine v trebuhu, ker ti simptomi lahko nakazujejo na pankreatitis (vnetje trebušne slinavke).
English: Outcomes at Week 48: Study M98-940* Antiretroviral Naïve (N=44)
Slovenian: Rezultati v 48. tednu: Študija M98-940* Bolniki, ki še niso bili zdravljeni s protiretrovirusnimi zdravili (N=44)
English: Apalutamide
Slovenian: Apalutamid
English: Patients taking the oral solution, particularly those with renal impairment or with decreased ability to metabolise propylene glycol (e.g. those of Asian origin), should be monitored for adverse reactions potentially related to propylene glycol toxicity (i.e. seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis) (see section 4.3).
Slovenian: Drugo Bolnike, ki uporabljajo peroralno raztopino, zlasti tiste z okvaro ledvic ali slabšo zmožnostjo za presnovo propilenglikola (npr. tiste azijskega porekla), je treba nadzirati glede neželenih učinkov, ki so lahko povezani s toksičnostjo propilenglikola (t.j.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz, 600 mg QD Lopinavir:
Slovenian: Nenukleozidni zaviralci reverzne transkriptaze (NNRTI) Efavirenz, 600 mg enkrat na dan
English: Kaletra is also supplied as 100 mg/25 mg film-coated tablets.
Slovenian: Zdravilo Kaletra je na voljo tudi kot 100 mg/25 mg filmsko obložene tablete.
English: Uncommon Gastrointestinal haemorrhage including gastrointestinal ulcer, duodenitis, gastritis and rectal haemorrhage, stomatitis and oral ulcers, faecal incontinence, constipation, dry mouth
Slovenian: bolečine v zgornjem in spodnjem delu trebuha, napihnjenost trebuha, dispepsija, hemoroidi, flatulenca občasni gastrointestinalna hemoragija, vključno z razjedami v prebavilih, duodenitis, gastritis in rektalna hemoragija, stomatitis in razjede v ustih, fekalna inkontinenca, zaprtje, suha usta
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Kaletra.
Slovenian: Med uporabo teh zdravil z zdravilom Kaletra je priporočljiv kliničen nadzor terapevtskih in neželenih učinkov.
English: dosage adjustment recommendations.
Slovenian: Glejte priporočila za odmerjanje pri odraslih
English: Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with Kaletra is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba sildenafila za zdravljenje pljučne arterijske hipertenzije in zdravila Kaletra je kontraindicirana (glejte poglavje 4.3).
English: Median baseline CD4 cell count was 349 cells/mm3 (range 72 to 807 cells/mm3) and median baseline plasma HIV-1 RNA was 4.0 log10 copies/ml (range 2.9 to 5.8 log10 copies/ml).
Slovenian: Mediano izhodiščno število celic CD4 je bilo 349 celic/mm3 (razpon od 72 do 807 celic/mm3) in mediana izhodiščna HIV-1 RNA v plazmi je bila 4,0 log10 kopij/ml (razpon od 2,9 do 5,8 log10 kopij/ml).
English: Kaletra oral solution is supplied in amber coloured multiple-dose polyethylene terephthalate (PET) bottles in a 60 ml size.
Slovenian: Zdravilo Kaletra peroralna raztopina je na voljo v 60 ml plastenkah za večkratno odmerjanje, jantarne barve, izdelane iz polietilentereftalata (PET).
English: Herbal products St John's wort (Hypericum perforatum)
Slovenian: Šentjanževka (Hypericum perforatum)
English: Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet. High potassium in the blood can cause stomach upset and diarrhoea.
Slovenian: Zdravilo Kaletra vsebuje kalij v obliki kalijevega acesulfamata, kar lahko škoduje ljudem na dieti z malo kalija.
English: • anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);
Slovenian: - antibiotiki (npr. rifabutin, rifampicin, klaritromicin); - zdravila proti raku (npr. abemaciklib, afatinib, apalutamid, ceritinib, enkorafenib, ibrutinib,
English: HIV RNA < 400 copies/ml
Slovenian: HIV RNA < 400 kopij/ml
English: • dizziness, anxiety, difficulty in sleeping;
Slovenian: - izpuščaj, ekcem, nabiranje lusk mastne kože; - omotica, anksioznost, težave s spanjem;
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Slovenian: Srednje povečanje števila T-celic CD4 od začetka (celic/mm3)
English: Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Slovenian: Dihidroergotamin, ergonovin, ergotamin, metilergonovin
English: The plasma levels of ritonavir are less than 7% of those obtained after the ritonavir dose of 600 mg twice daily.
Slovenian: Koncentracija ritonavirja v plazmi je bila manj kot 7 % tiste, ki je dosežena po odmerjanju ritonavirja 600 mg dvakrat na dan. Protivirusna EC50 lopinavirja in vitro je približno 10-krat manjša kot ritonavirja.
English: Film-coated tablet Pale yellow debossed with [Abbott logo] and “KC”.
Slovenian: filmsko obložena tableta Bledo rumena, z vtisnjenima oznakama [Abbottov logo] in "KC".
English: Kaletra oral solution contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Slovenian: Peroralna raztopina zdravila Kaletra, uporabljana skladno z navodili za odmerjanje, vsebuje do 0,8 g fruktoze na odmerek.
English: Lower respiratory tract infection, skin infections including cellulitis, folliculitis and furuncle
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužbe zgornjih dihal pogosti okužbe spodnjih dihal, kožne okužbe vključno s celulitisom, folikulitisom in furunkli
English: Medicinal products within class
Slovenian: Zdravilo znotraj skupine
English: Mean baseline CD4+ T-cell count was 838 cells/mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ml.
Slovenian: Povprečno izhodiščno število T-celic CD4 je bilo 838 celic/mm3, povprečna izhodiščna HIV-1 RNA v plazmi pa 4,7 log10 kopij/ml.
English: The dose of maraviroc should be decreased to 150 mg twice daily during co-administration with Kaletra 400/100 mg twice daily.
Slovenian: Kaletra 400/100 mg dvakrat na dan je potrebno odmerek maraviroka zmanjšati na 150 mg dvakrat na dan.
English: The treatment regimen was zidovudine plus lamivudine plus 300 mg lopinavir/75 mg ritonavir per m2 twice daily until 6 months of age, then 230 mg lopinavir/57.5 mg ritonavir per m2 twice daily.
Slovenian: Shema zdravljenja je vključevala zidovudin, lamivudin in 300 mg lopinavirja/75 mg ritonavirja na m2 dvakrat na dan do 6. meseca starosti, nato 230 mg lopinavirja/57,5 mg ritonavirja na m2 na dan. O dogodkih neuspeha zaradi toksičnosti, ki omejuje zdravljenje, niso poročali.
English: The use of vardenafil with Kaletra is contraindicated (see section 4.3).
Slovenian: Uporaba vardenafila z zdravilom Kaletra je kontraindicirana (glejte poglavje 4.3).
English: Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Slovenian: Ena tableta zdravila Kaletra vsebuje 100 mg lopinavirja in 25 mg ritonavirja.
English: Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Slovenian: Ena tableta zdravila Kaletra vsebuje 200 mg lopinavirja in 50 mg ritonavirja.
English: Hypertension Uncommon Deep vein thrombosis
Slovenian: Žilne bolezni pogosti hipertenzija občasni globoka venska tromboza
English: Serum cholesterol was elevated in rodents but not dogs, while triglycerides were elevated only in mice.
Slovenian: Pri podganah so opažali Coombs-negativno anizocitozo in poikilocitozo, pri miših in psih pa ne. Zvečanje vranice in histiocitozo so zabeležili pri podganah, pri drugih vrstah pa ne. Holesterol v serumu se je zvišal pri glodalcih, ne pa pri psih, medtem ko so se trigliceridi zvišali samo pri miših.
English: triamcinolone);
Slovenian: Kaletra);
English: 500/125 mg
Slovenian: 400/100 mg 500/125 mg
English: Mean baseline CD4+ T-cell count was 259 cells/mm3 (range: 2 to 949 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.9 log10 copies/ml (range: 2.6 to 6.8 log10 copies/ml).
Slovenian: Povprečno izhodiščno število T-celic CD4 je bilo 259 celic/mm3 (razpon: od 2 do 949 celic/mm3), povprečna izhodiščna HIV-1 RNA v plazmi pa je bila 4,9 log10 kopij/ml (razpon: od 2,6 do 6,8 log10 kopij/ml).
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir.
Slovenian: Pri bolnikih, ki so jih zdravili s kolhicinom in močnimi zaviralci CYP3A, kot je ritonavir, so poročali o življenjsko ogrožajočem in smrtnem medsebojnem delovanju.
English: HIV RNA < 400 copies/ml*
Slovenian: HIV RNA < 400 kopij/ml *
English: Lipid-modifying agents Lomitapide
Slovenian: Zdravila za spreminjanje ravni serumskih lipidov Lomitapid
English: Anti-gout agents: Colchicine single dose
Slovenian: Zdravila za zdravljenje protina Kolhicin - enkraten odmerek
English: Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Slovenian: Zdravilo Kaletra vsebuje lopinavir in ritonavir, ki zavirata izoobliko CYP3A P450.
English: Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Slovenian: Kaletra 200 mg/50 mg filmsko obložene tablete lopinavir/ritonavir
English: Steady-state concentrations was moderately decreased due to CYP2C9 and CYP2C19 induction by lopinavir/ritonavir.
Slovenian: Fenitoin: zaradi indukcije CYP2C9 in CYP2C19 z lopinavirjem/ritonavirjem je bila koncentracija v stanju dinamičnega ravnovesja zmerno znižana.
English: Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Slovenian: En ml peroralne raztopine zdravila Kaletra vsebuje 80 mg lopinavirja, koformuliranega z 20 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
English: HIV, respectively.
Slovenian: HIV.
English: Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Slovenian: Kaletra 100 mg/25 mg filmsko obložene tablete lopinavir/ritonavir
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
English: Skin and subcutaneous tissue disorders
Slovenian: palpitacijami in sinusno tahikardijo.
English: Mean baseline CD4+ T-cell count was 254 cells/mm3 (range: 4 to 952 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.3 log10 copies/ml (range: 1.7 to 6.6 log10 copies/ml).
Slovenian: Povprečno izhodiščno število T-celic CD4 je bilo 254 celic/mm3 (razpon: od 4 do 952 celic/mm3) in povprečna izhodiščna HIV-1 RNA v plazmi je bila 4,3 log10 kopij/ml (razpon: od 1,7 do 6,6 log10 kopij/ml).
English: As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Slovenian: V splošnem se priporoča, da doječe matere, okužene z virusom HIV,
English: In addition, co-administration of apalutamide and Kaletra may lead to serious adverse events including seizure due to higher apalutamide levels.
Slovenian: Poleg tega sočasna uporaba apalutamida in zdravila Kaletra zaradi povečanih ravni apalutamida lahko vodi k pojavu resnih neželenih učinkov,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Oral solution - Carton containing 120 ml (2 bottles x 60 ml) oral solution
Slovenian: PODATKI NA ZUNANJI OVOJNINI Peroralna raztopina - škatla, ki vsebuje 120 ml (2 plastenki po 60 ml) peroralne raztopine
English: Thirty-nine patients (39%) discontinued the study, including 16 (16%) discontinuations due to adverse events, one of which was associated with a death.
Slovenian: %) prenehanji zaradi neželenih dogodkov, eden izmed teh je bil povezan s smrtjo.
English: Ergot alkaloids Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Slovenian: Ergot alkaloidi Dihidroergotamin, ergonovin, ergotamin, metilergonovin
English: Kaletra must not be administered once daily in combination with efavirenz.
Slovenian: Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji z efavirenzem.
English: HCV direct acting antivirals Elbasvir/grazoprevir (50/200 mg QD)
Slovenian: Elbasvir/grazoprevir (50/200 mg enkrat na dan)
English: When given with Kaletra the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-WednesdayFriday).
Slovenian: Pri sočasni uporabi rifabutina in zdravila Kaletra je priporočljiv odmerek rifabutina 150 mg 3-krat na teden ob določenih dnevih
English: or
Slovenian: ali
English: Thereby, increasing the risk of arrhythmias or other serious adverse reactions (see section 4.5).
Slovenian: Zaradi tega večje tveganje za motnje srčnega ritma ali druge resne neželene učinke (glejte poglavje 4.5).
English: Kaletra 200 mg/50 mg film-coated tablets:
Slovenian: Kaletra 200 mg/50 mg filmsko obložene tablete:
English: Nevirapine, 200 mg BID
Slovenian: Nevirapin, 200 mg dvakrat na dan
English: Kaletra must not be administered once daily in combination with nevirapine.
Slovenian: Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji z nevirapinom.
English: The concomitant administration with quetiapine is contraindicated (see section 4.5).
Slovenian: Sočasna uporaba s kvetiapinom je kontraindicirana (glejte poglavje 4.5).
English: Between week 24 and 48, patients randomised to a dose of 400/100 mg were converted to a dose of 533/133 mg.
Slovenian: Med 24. in 48. tednom so bolniki, randomizirani na odmerek 400/100 mg, prešli na odmerek 533/133 mg. Mediano izhodiščno število celic CD4 je bilo 220 celic/mm3 (razpon od 13 do 1030 celic/mm3).
English: How to store Kaletra
Slovenian: Shranjevanje zdravila Kaletra
English: Multiple dosing of 800/200 mg Kaletra once daily for 2 weeks without meal restriction (n=16) produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 14.8 ± 3.5 µg/ml, occurring approximately 6 hours after administration.
Slovenian: Zdravilo Kaletra 800/200 mg so uporabljali v kombinaciji z emtricitabinom 200 mg in tenofovirjem DF 300 mg kot del sheme enkrat na dan. Večkratno odmerjanje 800/200 mg zdravila Kaletra enkrat na dan 2 tedna in brez omejevanja obrokov (n = 16) je povzročilo povprečno največjo koncentracijo (Cmax) lopinavirja v plazmi ± SD 14,8 ± 3,5 µg/ml, in sicer približno 6 ur po uporabi.
English: Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section
Slovenian: Zvišana koncentracija neratiniba v plazmi, ki lahko poveča tveganje za resne in/ali življenje ogrožajoče reakcije (glejte poglavje
English: Recommended number of 100/25 mg tablets twice-daily
Slovenian: Kaletra 100/25 mg dvakrat na dan
English: Outcomes at Week 48: Study M98-940 Antiretroviral Naïve (N=44)
Slovenian: Rezultati v 48. tednu: Študija M98-940 Bolniki, ki še niso bili zdravljeni s protiretrovirusnimi zdravili (N=44)
English: Due to CYP3A4 inhibition by lopinavir/ritonavir.
Slovenian: Zaradi zavrtja CYP3A4 z lopinavirjem/ritonavirjem.
English: Lopinavir and ritonavir levels may increase on stopping St John's wort.
Slovenian: Koncentraciji lopinavirja in ritonavirja se lahko po prekinitvi jemanja šentjanževke zvišata.
English: Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness, insomnia
Slovenian: Bolezni živčevja pogosti glavobol (vključno z migreno), nevropatija (vključno s periferno nevropatijo), omotica, nespečnost občasni možgansko-žilni dogodki, konvulzije, disgevzija, agevzija, tremor
English: Adverse reactions from clinical trials and post-marketing experience in adult and paediatric patients:
Slovenian: b. Seznam neželenih učinkov v preglednici Neželeni učinki v kliničnih študijah in iz obdobja trženja zdravila pri odraslih in pediatričnih bolnikih:
English: Particular caution must be used when prescribing sildenafil or tadalafil in patients receiving Kaletra with increased monitoring for adverse events including hypotension, syncope, visual changes and prolonged erection (see section 4.4).
Slovenian: Pričakovati je treba, da sočasna uporaba zdravila 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: • fatty deposits in the liver, enlarged liver;
Slovenian: - rdeče krvničke v urinu; - maščobni depoziti v jetrih, povečana jetra;
English: Mean baseline CD4+ T-cell count was 216 cells/mm3 (range: 20 to 775 cells/mm3) and mean baseline plasma HIV-1 RNA was 5.0 log10 copies/ml (range: 1.7 to 7.0 log10 copies/ml).
Slovenian: 216 celic/mm3 (razpon: od 20 do 775 celic/mm3) in povprečna izhodiščna HIV-1 RNA v plazmi je bila 5,0 log10 kopij/ml (razpon: od 1,7 do 7,0 log10 kopij/ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg tablets - Carton of 1 bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI 200 mg/50 mg tablete - škatla z 1 plastenko
English: The concomitant administration with quetiapine is contraindicated (see section
Slovenian: Sočasna uporaba s kvetiapinom je kontraindicirana (glejte poglavje
English: The effect on DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg BID was administered (see section 4.3).
Slovenian: Učinek na zdravila z direktnim delovanjem na viruse in lopinavir je bil podoben kot pri uporabi lopinavirja/ritonavirja 400/100 mg 2x dnevno (glejte poglavje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 100 mg/ 25 mg tablets - Carton of 1 bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI 100 mg/25 mg tablete - škatla z 1 plastenko
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected children above the age of 2 years, adolescents and adults.
Slovenian: Zdravilo Kaletra je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje otrok, starejših od 2 let, mladostnikov in odraslih, okuženih z virusom (HIV-1), ki povzroča imunsko pomanjkljivost.
English: Increased plasma concentrations of lurasidone which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Slovenian: Večja koncentracija lurasidona v plazmi, ki lahko poveča možnost za resne in/ali življenje ogrožajoče reakcije (glejte poglavje 4.5).
English: Kaletra 100 mg/25 mg film-coated tablets
Slovenian: Kaletra 100 mg/25 mg filmsko obložene tablete
English: All interaction studies, when otherwise not stated, were performed using Kaletra capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Slovenian: kar pomeni za približno 20 % nižjo izpostavljenost lopinavirju kot pri 200/50 mg tabletah.
English: Kaletra film-coated tablets are pale yellow debossed with [Abbott logo] and “KC”.
Slovenian: Filmsko obložene tablete zdravila Kaletra so bledo rumene in imajo vtisnjeni oznaki [Abbottov logo] in "KC".
English: (Lopinavir/ritonavir 400/100 mg BID)
Slovenian: (Lopinavir/ritonavir 400/100 mg dvakrat na dan)
English: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
Slovenian: Zdravilo Kaletra je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starejših od 2 let, okuženih z virusom (HIV-1), ki povzroča imunsko pomanjkljivost.
English: • haemorrhoids;
Slovenian: - vnetje žolčnih vodov;
English: The following tables contain dosing guidelines for Kaletra oral solution based on body weight and BSA.
Slovenian: Naslednja tabela prikazuje smernice za odmerjanje tablet zdravila Kaletra glede na telesno površino,
English: Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided.
Slovenian: Kombinaciji bedakilina z zdravilom Kaletra se je treba zaradi tveganja za neželene učinke povezane z bedakilinom izogibati.
English: The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section
Slovenian: Sočasna uporaba fusidne kisline je kontraindicirana pri dermatoloških okužbah.
English: Outcomes at Week 360: Study M97-720
Slovenian: Rezultati v 360.tednu: Študija M97-720 Kaletra (N=100)
English: Co-administration of abemaciclib and Kaletra should be avoided.
Slovenian: Sočasni uporabi abemacikliba in zdravila Kaletra se je potrebno izogniti.
English: Antianginal
Slovenian: Antiaritmiki
English: Kaletra is also supplied as 200 mg/50 mg film-coated tablets.
Slovenian: Zdravilo Kaletra je na voljo tudi kot 200/50 mg filmsko obložene tablete.