natgillin/translations-raw huggingface dataset:
Increased activated partial thromboplastin time, decreased haemoglobin, decreased platelets, increased sodium, increased potassium, increased calcium, increased bilirubin, increased SGPT/ ALT, increased SGOT/ AST, increased total cholesterol, increased amylase, increased uric acid, decreased sodium, decreased potassium, decreased calcium, decreased neutrophils
Zvišan aktivirani parcialni tromboplastinski čas, znižan hemoglobin, zmanjšano število trombocitov, zvišan natrij, zvišan kalij, zvišan kalcij, zvišan bilirubin, zvišana SGPT/ ALT, zvišana SGOT/ AST, zvišan celokupni holesterol, zvišana amilaza, zvišana sečna kislina, znižan natrij, znižan kalij, znižan kalcij, zmanjšano število nevtrofilcev
35 Post marketing experience
Pomarketinške izkušnje
Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Ker je zdravilo Kaletra v
Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
37 veliki meri vezana na beljakovine, ni verjetno, da bi dializa pomembno odstranila zdravilno učinkovino.
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.
3- krat večja, kot je ugotovljena med uporabo priporočenih odmerkov lopinavirja/ ritonavirja enkrat oz. dvakrat na dan v stanju dinamičnega ravnovesja.
In the absence and presence of 50% human serum, the mean IC50 of
V odsotnosti oz. prisotnosti 50% človeškega seruma je bila povprečna IC50 lopinavirja proti HIV- 1IIIB v celicah MT4 17 nM oz.
36 lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
102 nM.
Analysis of resistance in ARV-naïve patients:
38 Analiza odpornosti pri bolnikih, naivnih za protiretrovirusna zdravila:
Of these, isolates from 96 nelfinavir-treated subject and 51 lopinavir/ ritonavir-treated subjects could be amplified for resistance testing.
Med temi je bilo mogoče za testiranje odpornosti amplificirati izolate 96 preiskovancev, zdravljenih z nelfinavirjem, in 51 preiskovancev, zdravljenih z lopinavirjem/ ritonavirjem.
37 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.
Pri izolatih s preobratom, to je z manjšo občutljivostjo za lopinavir pri bolnikih, ki so dobivali zdravilo Kaletra, so opažali tudi mutaciji I47A in L76V.
The EC50 of lopinavir against the 56 baseline viral isolates ranged from 0.6 to 96-fold higher than the EC50 against wild type HIV.
Protivirusno delovanje zdravila Kaletra pri bolnikih, pri katerih je bilo zdravljenje z zaviralci proteaz neuspešno: 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.
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.
39 transkriptaze so HIV RNA v plazmi ≤ 400 izvodov/ ml ugotovili pri 93% (25/ 27), 73% (11/ 15), in 25% (2/ 8) bolnikov z < 10- krat, 10 - do 40- krat oz. > 40- krat zmanjšano izhodiščno občutljivostjo za lopinavir.
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.
8– 10 zgoraj omenjenimi mutacijami proteaze HIV, povezan z manjšo občutljivostjo za lopinavir in vitro.
Isolates retained susceptibility to tipranavir with a median increase of IC50 in baseline and rebound isolates of 1.9- and 1.8– fold, respectively, compared to wild type virus.
Izolati so ohranili občutljivost za tipranavir s srednjim (mediana) povečanjem IC50 v izhodiščnih izolatih za 1, 9- krat in izolatih po preobratu za 1, 8- krat v primerjavi z divjim tipom virusa.
Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Za dodatne informacije o tipranavirju (vključno z genotipsko napovedjo odziva, pri zdravljenju okužbe s HIV- 1, odporne proti lopinavirju) glejte povzetek glavnih značilnosti zdravila Aptivis.
The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4 counts) have been investigated in a controlled study of Kaletra of 48 weeks duration, and in additional studies of Kaletra of 360 weeks duration.
Učinke zdravila Kaletra (v kombinaciji z drugimi protiretrovirusnimi zdravili) na biološke označevalce (koncentracijo HIV RNA in število celic CD4 v plazmi) so raziskali v kontrolirani 48- tedenski študiji zdravila Kaletra ter v dodatnih 360- tedenskih študijah zdravila Kaletra.
All patients converted to open-label Kaletra at the 400/ 100 mg twice daily
Vsi bolniki so med 48. in 72. tednom prešli na odprto uporabo zdravila Kaletra v odmerku 400/ 100 mg dvakrat na dan.
Through 360 weeks of treatment, the proportion of patients with HIV RNA < 400 (< 50) copies/ ml was 61% (59%), and the corresponding mean increase in CD4 cell count was 501 cells/ mm3.
Med 360 tedni zdravljenja je bil delež bolnikov s HIV RNA < 400 (< 50) izvodov/ mi 61% (59%) in ustrezajoči povprečni porast CD4 celic
By intent-to-treat analysis where patients with missing values are considered virologic failures, the proportion of patients with HIV RNA < 400 (< 50) copies/ ml at 24 weeks was 75% (58%) and the mean increase from baseline in CD4 cell count was 174 cells/ mm3 for the 36 patients receiving the 400/ 100 mg dose of Kaletra.
Po analizi z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh, je bil pri 36 bolnikih, ki so dobivali odmerek zdravila Kaletra 400/ 100 mg, delež bolnikov s HIV RNA < 400 izvodov/ ml po 24 tednih 75% (58%) in povprečno zvečanje števila celic CD4 od izhodišča 174 celic/ mm3 za 36 bolnikov, ki so dobivali zdravilo Kaletra v odmerku 400/ 100 mg.
Median baseline CD4 cell count was 220 cells/ mm3 (range13 to 1030 cells/ mm3).
Mediano izhodiščno število celic CD4 je bilo 220 celic/ mm3 (razpon od 13 do 1030 celic/ mm3).
By intent-to-treat analysis of both dose groups combined (n=57), where patients with missing values are considered virologic failures, the proportion of patients with HIV RNA < 400 copies/ ml at 48 weeks was 65% and the mean increase from baseline CD4 cell count was 94 cells/ mm3.
Po analizi z namenom zdravljenja obeh odmernih skupin skupaj (n = 57), pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh, sta bila delež bolnikov s HIV RNA < 400 (< 50) izvodov/ ml po 48 tednih 65% in povprečno zvečanje števila celic CD4 od izhodišča 94 celic/ mm3.
Through 48 weeks of therapy, the proportion of patients with HIV RNA < 400 copies/ ml was 84% for antiretroviral naïve patients and 75% for antiretroviral experienced patients and the mean increase from baseline in CD4 cell count were 404 cells/ mm3 and 284 cells/ mm3 respectively.
Med 48 tedni zdravljenja je bil delež bolnikov s HIV RNA < 400 izvodov/ ml 84% med protiretrovirusno naivnimi bolniki in 75% med protiretrovirusno izkušenimi bolniki; povprečno zvečanje števila celic CD4 od izhodišča je bilo 404 celice/ mm3 med prvimi in 284 celic/ mm3 med drugimi.
39 Absorption: multiple dosing with 400/ 100 mg Kaletra twice daily for 3 to 4 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 9.6 ± 4.4 μ g/ ml, occurring approximately 4 hours after administration.
Večkratno odmerjanje 400/ 100 mg zdravila Kaletra dvakrat na dan 3 do 4 tedne in brez omejevanja obrokov je povzročilo povprečno največjo plazemsko koncentracijo (Cmax) ± SD lopinavirja 9, 6 ± 4, 4 μg/ ml, in sicer približno 4 ure po uporabi.
The mean steady-state trough concentration prior to the morning dose was 5.5 ± 4.0 μ g/ ml.
Povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja pred jutranjim odmerkom je bila 5, 5 ± 4, 0 μg/ ml.
Lopinavir AUC over a 12 hour dosing interval averaged 82.8 ± 44.5 μ g• h/ ml.
AUC lopinavirja med 12- urnim odmernim intervalom je bila v povprečju 82, 8 ± 44, 5 μg• h/ ml.
Distribution: at steady state, lopinavir is approximately 98 − 99% bound to serum proteins.
V stanju dinamičnega ravnovesja je lopinavir približno 98 - do 99- odstotno vezan na serumske beljakovine.
Elimination: 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.
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%.
40 Gender, Race and Age:
42 Spol, rasa in starost:
While exposure eliciting these changes were comparable to or below human clinical exposure, dosages in animals were over 6-fold the recommended clinical dose.
Čeprav je bila izpostavljenost, ki je izzvala te spremembe, primerljiva klinični izpostavljenosti pri ljudeh ali manjša od nje, so odmerki pri živalih več kot 6- krat presegali priporočeni klinični odmerek.
The clinical relevance of these preclinical data is unknown, however, the potential cardiac effects of this product in humans cannot be ruled out (see also sections 4.4 and 4.8).
Klinični pomen teh predkliničnih podatkov ni znan, vendar kardialnih učinkov tega zdravila pri človeku ni mogoče izključiti (glejte tudi poglavji 4. 4 in 4. 8).
41 Long-term carcinogenicity studies of lopinavir/ ritonavir in mice revealed a nongenotoxic, mitogenic induction of liver tumours, generally considered to have little relevance to human risk.
43 Dolgotrajne študije lopinavirja/ ritonavirja pri miših so pokazale negenotoksično, mitogeno indukcijo jetrnih tumorjev, za katero na splošno velja, da je malo pomembna za tveganje pri človeku.
Oral solution contains: alcohol (42% v/ v), high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotrope, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, menthol.
Peroralna raztopina vsebuje: alkohol (42% v/ v) visokofruktozni koruzni sirup propilenglikol prečiščeno vodo glicerol povidon aromo Magnasweet- 110 (mešanica monoamonijevega glicirizinata in glicerola) aromo vanilije (vsebuje p- hidroksibenzojsko kislino, p- hidroksibenzaldehid, vanilinsko kislino, vanilin, heliotrop, etilvanilin) makrogolglicerol hidroksistearat 40 aromo sladkorne pene (vsebuje etilmaltol, etilvanilin, acetoin, dihidrokumarin, propilenglikol) kalijev acesulfamat natrijev saharinat natrijev klorid eterično olje poprove mete natrijev citrat citronsko kislino mentol
Amber coloured multiple-dose polyethylene terephthalate (PET) bottles in a 60 ml size.
60 ml stekleničke za večkratno odmerjanje, jantarne barve, izdelane iz polietilentereftalata (PET).
Each pack contains 5 bottles of 60 ml (300 ml).
Vsako pakiranje vsebuje 5 stekleničk po 60 ml (300 ml).
The pack also contains 5 x 5 ml syringes with 0.1 ml graduations from 0 to 5 ml (400/ 100 mg).
Pakiranje vsebuje tudi pet 5- ml brizg z 0, 1- ml oznakami od 0 do 5 ml (400/ 100 mg).
6.6 Special precautions for disposal
44 6. 6 Posebni varnostni ukrepi za odstranjevanje
Kaletra 200 mg/ 50 mg film-coated tablets
Kaletra 200 mg/ 50 mg filmsko obložene tablete
Yellow embossed with [Abbott logo] and “ KA”.
Rumena, z vtisnjenima oznakama [Abbottov logo] in "KA".
Kaletra tablets should be swallowed whole and not chewed, broken or crushed
Tablete Kaletra mora bolnik zaužiti cele in jih ne sme žvečiti, lomiti ali drobiti.
Adult and adolescent use: the recommended dosage of Kaletra tablets is two 200/ 50 mg tablets twice daily taken with or without food..
Priporočeni odmerek tablet Kaletra je dve 200/ 50 mg tableti dvakrat na dan, zaužite s hrano ali brez nje.
Paediatric use (2 years of age and above): the adult dose of Kaletra tablets (400/ 100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Odmerek tablet Kaletra za odrasle (400/ 100 mg dvakrat na dan) lahko uporabite pri otrocih, ki tehtajo 40 kg ali več ali imajo telesno površino * večjo od 1, 4 m2.
For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/ 25 mg tablets Summary of Product Characteristics.
Za otroke, ki tehtajo manj kot 40 kg ali imajo telesno površino med 0, 5 in 1, 4 m2 ter zmorejo pogotniti tablete, glejte povzetek glavnih značilnosti zdravila Kaletra 100 mg/ 25 mg filmsko obložene tablete.
For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics.
Za otroke, ki tablet ne morejo zaužiti, glejte povzetek glavnih značilnosti zdravila za peroralno raztopino Kaletra.
* Body surface area can be calculated with the following equation:
46 * Telesno površino lahko izračunate po naslednji enačbi:
Children less than 2 years of age:
Otroci do 2. leta starosti:
Kaletra is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy (see section 5.1).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Kaletra pri otrocih pod 2 leti ni priporočljiva (glejte poglavje 5. 1).
The following table contains dosing guidelines for Kaletra tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Sočasna zdravila: efavirenz ali nevirapin Naslednja tabela prikazuje smernice za odmerjanje tablet Kaletra glede na telesno površino, če so tablete pri otrocih uporabljene v kombinaciji z efavirenzem ali nevirapinom.
Recommended lopinavir/ ritonavir dosing (mg) twice daily.
Odmerjanje pri otrocih ob sočasni uporabi efavirenza ali nevirapina Priporočeni odmerki lopinavirja/ ritonavirja Telesna površina (m2) (mg) dvakrat na dan.
The adequate dosing may be achieved with the two available strengths of Kaletra tablets:
Zadostne odmerke se lahko doseže z dvema dosegljivima jakostima Kaletra tablet:
100/ 25 mg and 200/ 50 mg. *
100/ 25 mg in 200/ 50 mg. *
≥ 0.5 to < 0.8 ≥ 0.8 to < 1.2
≥ 0, 5 do < 0, 8 ≥ 0, 8 do < 1, 2
≥ 1.2 to < 1.4 ≥ 1.4
≥ 1, 2 do < 1, 4 ≥ 1, 4
* Kaletra tablets must not be chewed, broken or crushed.
* Tablet Kaletra se ne sme žvečiti, lomiti ali drobiti.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolnike s kroničnim hepatitisom B ali C, ki dobivajo kombinirano protiretrovirusno
45 Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pri bolnikih z obstoječo disfunkcijo jeter, vključno s kroničnim hepatitisom, se med kombiniranim protiretrovirusnim zdravljenjem pogosteje pojavljajo nepravilnosti v delovanju jeter, zato jih je treba nadzirati v skladu s standardno prakso.
Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Številni bolniki so imeli dodatne bolezni in nekatere so zahtevale zdravljenje z zdravili, ki so povezana s pojavom diabetesa mellitusa ali hiperglikemije.
Fat redistribution and metabolic disorders
Prerazporeditev maščevja in presnovne motnje
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Večje tveganje za
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
48 lipodistrofijo je povezano z individualnimi dejavniki, npr. večjo starostjo, in dejavniki, povezanimi z zdravili, npr. z dolgotrajnejšim protiretrovirusnim zdravljenjem in spremljajočimi presnovnimi motnjami.
Clinical examination should include evaluation for physical signs of fat
Klinični pregled mora obsegati tudi iskanje telesnih znakov prerazporeditve maščevja.
Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
Zadostno izpostavljenost kombinaciji
Adequate exposure to lopinavir/ ritonavir may be achieved when a higher dose of Kaletra is used but this is associated with a higher risk of liver and gastrointestinal toxicity.
49 lopinavir/ ritonavir se lahko doseže z uporabo višjega odmerka zdravila Kaletra, vendar je to povezano z večjim tveganjem za jetrno in gastrointestinalno toksičnost.
47 Other
Drugo
It does not reduce the risk of passing HIV to others through sexual contact or blood contamination.
Prav tako ne zmanjša tveganja za prenos HIV na druge s spolnim stikom ali kontaminacijo s krvjo.
Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing’ s syndrome and adrenal suppression (see section 4.5).
Sočasne uporabe zdravila Kaletra in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ni priporočljiva, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4. 5).
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.
Razen v primerih, kjer je navedeno drugače, so bile vse študije medsebojnega delovanja zdravil izvedene s kapsulami Kaletra, pri katerih je izpostavljenost lopinavirju približno 20% nižja kot pri tabletah jakosti 200/ 50 mg.
Didanosine: it is recommended that didanosine be administered on an empty stomach; therefore, didanosine may be co-administered with Kaletra tablets without food.
Didanozin: priporočljivo je, da bolnik didanozin vzame na prazen želodec, zato ga lahko uporabi hkrati s tabletami Kaletra brez hrane.
Kaletra induces glucuronidation; therefore Kaletra has the potential to reduce zidovudine and abacavir plasma concentrations.
Zdravilo Kaletra inducira glukuronidacijo, zato lahko zmanjša plazemsko koncentracijo zidovudina in abakavirja.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs):
50 Nenukleozidni zaviralci reverzne transkriptaze (NNRTI - Non- nucleoside reverse transcriptase inhibitors):
In a study performed in healthy volunteers to explore the interaction between Kaletra tablets (400/ 100 mg twice daily) and efavirenz (600 mg once daily), efavirenz has been shown to decrease the lopinavir concentrations by 30 - 40%.
Študija, ki so jo opravili pri zdravih prostovoljcih za proučitev medsebojnega delovanja tablet Kaletra (400/ 100 mg dvakrat na dan) in efavirenza (600 mg štirikrat na dan), je pokazala, da efavirenz zmanjša koncentracijo lopinavirja za 30– 40%.
When Kaletra tablet dosages were increased to 500/ 125 mg twice daily during co-administration of efavirenz 600 mg once daily in healthy volunteers, lopinavir pharmacokinetic parameters were similar to those obtained with Kaletra tablets 400/ 100 mg twice daily administered alone.
Če so pri zdravih prostovoljcih odmerjanje tablet Kaletra med sočasno uporabo s 600 mg efavirenza enkrat na dan povečali na 500/ 125 mg dvakrat na dan, so bili farmakokinetični parametri lopinavirja podobni kot med uporabo samih tablet Kaletra 400/ 100 mg dvakrat na dan.
Therefore, the Kaletra tablets dosage should be increased to 500/ 125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Zato morate med sočasno uporabo s 600 mg efavirenza enkrat na dan odmerjanje tablet Kaletra povečati na 500/ 125 mg dvakrat na dan.
48 Similar pharmacokinetic interactions are expected for the co-administration of Kaletra tablets with the NNRTI nevirapine and with the protease inhibitors nelfinavir and amprenavir.
Podobne farmakokinetične interakcije je mogoče pričakovati med sočasno uporabo tablet Kaletra z NNRTI nevirapinom in zaviralcema proteaz nelfinavirjem in amprenavirjem.
The same recommendations for monitoring apply in these cases of co-administration.
Tudi v primerih sočasne uporabe teh zdravil veljajo enaka priporočila za spremljanje.
Amprenavir: see recommendations described for Kaletra tablets co-administration with efavirenz.
Amprenavir: glejte priporočila, opisana za sočasno uporabo tablet Kaletra z efavirenzom.
Nelfinavir: see recommendations described for Kaletra tablets co-administration with efavirenz.
Nelfinavir: glejte priporočila, opisana za sočasno uporabo tablet Kaletra z efavirenzom.
Ritonavir:
51 Ritonavir:
Anticonvulsants (phenobarbital, phenytoin, carbamazepine): will induce CYP3A4 and may decrease lopinavir concentrations.
(fenobarbital, fenitoin, karbamazepin): inducirajo CYP3A4 in lahko zmanjšajo koncentracijo lopinavirja.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Kaletra is not recommended.
Zvečana koncentracija zaviralcev reduktaze HMG- CoA lahko povzroči miopatijo, vključno z rabdomiolizo, zato njihovo kombiniranje z
The metabolism of pravastatin and fluvastatin is not
Rezultati interakcijske raziskave z zdravilom Kaletra in pravastatinom ne kažejo klinično pomembnega medsebojnega delovanja.
50 dependent on CYP3A4, and interactions are not expected with Kaletra.
Presnova pravastatina in fluvastatina ni odvisna od CYP3A4 in medsebojnega delovanja z zdravilom Kaletra ni pričakovati.
Rifampicin: co-administration of Kaletra with rifampicin is not recommended.
53 Rifampicin: sočasna uporaba zdravila Kaletra in rifampicina ni priporočljiva.
51 St John’ s wort: serum levels of lopinavir and ritonavir can be reduced by concomitant use of the herbal preparation St John’ s wort (Hypericum perforatum).
Šentjanževka: sočasna uporaba zeliščnih pripravkov šentjanževke (Hypericum perforatum) lahko zmanjša koncentracijo lopinavirja in ritonavirja v serumu.
Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules twice daily were co − administered with 50 μ g intranasal fluticasone propionate (4 times daily) for seven days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82 − 89%).
Flutikazonpropionat (interakcija z ritonavirjem): pri zdravih osebah, ki so med klinično študijo 7 dni sočasno prejemale ritonavir v obliki 100 mg kapsul dvakrat dnevno in flutikazonpropionat v odmerku 50 μg intranazalno (4- krat dnevno), so ugotovili, da so se vrednosti flutikazonpropionata v plazmi znatno povečale, intrinzične vrednosti kortizola pa zmanjšale za približno 86% (90% interval zaupanja; 82 – 89%).