natgillin/translations-raw huggingface dataset:
The pharmacokinetics of Kaletra 300/75 mg/m2 twice daily with nevirapine and 230/57.5 mg/ m2 twice daily alone have been studied in 53 paediatric patients ranging in age from 6 months to 12 years.
Farmakokinetika lijeka Kaletra u dozi od 300/75 mg/m² dvaput na dan u kombinaciji s nevirapinom te u dozi od 230/57,5 mg/m² dvaput na dan bez drugih lijekova ispitivala se u ukupno 53 pedijatrijska bolesnika u dobi od 6 mjeseci do 12 godina.
Package leaflet: Information for the user Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Uputa o lijeku: Informacije za korisnika Kaletra 100 mg/25 mg filmom obložene tablete lopinavir/ritonavir
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.
Kaletra sadrži kalij u obliku acesulfamkalija, koji može biti štetan bolesnike s ograničenjem unosa kalija.
Package leaflet: Information for the user Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Uputa o lijeku: Informacije za korisnika Kaletra 200 mg/50 mg filmom obložene tablete lopinavir/ritonavir
Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after 3 weeks of therapy in each patient.
tjedna liječenja procijenjeni sigurnost, djelotvornost i farmakokinetički profil dvaju režima primjene.
− 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.
Ako uzimate lijek Kaletra jedanput na dan ̵ Ako unutar 12 sati od vremena kada ste trebali uzeti lijek primijetite da ste propustili uzeti jednu dozu, što prije uzmite propuštenu dozu, a potom nastavite uzimati lijek prema uobičajenom rasporedu kako Vam je propisao Vaš liječnik.
Glecaprevir/pibrentasvir Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
Glekaprevir/pibrentasvir Serumske koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na P-glikoprotein, BCRP i OATP1B (polipeptid za prijenos organskih aniona (engl. organic anion transporting polypeptide)).
This may cause nausea, vomiting, colic, severe purgation at high doses.
Uzeto u visokim dozama može izazvati mučninu, povraćanje, kolike (grčevi u trbuhu) i jak proljev.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 100 mg/ 25 mg tablets - Carton of 1 bottle
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 100 mg/ 25 mg tablete - Kutija s 1 bocom
Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Dihidroergotamin, ergonovin, ergotamin, metilergonovin
Open the child-proof cap by pushing down on it with your palm and twisting it counter clockwise, or in the direction of the arrow on the top of the cap. Talk to your pharmacist if you have difficulty opening the bottle.
Otvorite zatvarač siguran za djecu tako da ga pritisnete dlanom i zavrnete obrnuto od kazaljke na satu ili u smjeru strelice na vrhu zatvarača.
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).
Srednja početna vrijednost broja CD4+ T stanica je bila 259 stanica/mm3 (raspon 2 do 949 stanica/mm3) i srednja početna vrijednost HIV-1 RNK u plazmi je bila 4,9 log10 kopija/ml (raspon: 2,6 do 6,8 log10 kopija/ml).
Antiarrhythmics
Antiaritmici
Increased plasma concentrations of fusidic acid.
Povišena koncentracija fusidatne kiseline u plazmi.
AUC: ↔ Cmax: ↔ C12: ↓ 30% Lopinavir: ↔
AUC: ↔ Cmax: ↔ C12: ↓ 30%
The concomitant administration with quetiapine is contraindicated (see section 4.5).
Istodobna primjena s kvetiapinom je kontraindicirana (vidjeti dio 4.5).
Furthermore, polyoxol 40 hydrogenated castor oil and potassium present in Kaletra oral solution may cause only at high inadvertent doses gastrointestinal upset.
također prisutni u Kaletra oralnoj otopini, mogu samo pri velikim, nehotice uzetim dozama izazvati gastrointestinalne smetnje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg tablets - Carton of 1 bottle
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 200 mg/50 mg tablete - kutija s 1 bocom
Ergot alkaloids Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Ergot alkaloidi Dihidroergotamin, ergonovin, ergotamin, metilergonovin
GI motility agent Cisapride
Lijekovi koji utječu na gastrointestinalni motilitet Cisaprid
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).
Srednja početna vrijednost broja stanica CD4+ bila je 216 stanica/mm³ (raspon od 20 do 775 stanica/mm³), a srednja početna vrijednost HIV-1 RNK u plazmi bila je 5,0 log10 kopija/ml (raspon od 1,7 do 7,0 log10 kopija/ml).
Increased plasma concentrations of ranolazine which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Povišena koncentracija ranolazina u plazmi, što može povećati mogućnost nastupa ozbiljnih i/ili po život opasnih reakcija (vidjeti dio 4.5).
Medicinal products within class
Skupina lijekova Lijek unutar skupine
• If the ‘ml' mark on the collar is more than the prescribed dose, push the plunger to the prescribed dose.
• Ako je broj „ml“ u ravnini obruča veći od propisane doze, potiskujte klip dok se obruč ne poravna s oznakom za propisanu dozu.
Kaletra 200 mg/50 mg film-coated tablets:
Kaletra 200 mg/50 mg filmom obložene tablete:
Increased plasma concentrations of lurasidone which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Povišena koncentracija lurasidona u plazmi, što može povećati mogućnost nastupa ozbiljnih i/ili po život opasnih reakcija (vidjeti dio 4.5).
Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Srednja vrijednost porasta od početne vrijednosti u broju CD4+ T-stanica (stanica/mm3)
• Kaletra is not a cure for HIV infection or AIDS.
• Kaletra neće izliječiti HIV infekciju ni sindrom stečene imunodeficijencije (AIDS; engl.
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.
Sljedeća tablica sadrži smjernice za doziranje Kaletra tableta, korištenih u djece u kombinaciji s efavirenzom ili nevirapinom, temeljeno na površini tijela.
Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
U bolesnika liječenih lijekom Kaletra, uključujući i one koji su oboljeli od hipertrigliceridemije, zabilježena je pojava pankreatitisa.
Refer to the afatinib SmPC for
Vidjeti sažetak opisa svojstava lijeka za afatinib za
HIV RNA < 400 copies/ml Mean increase from baseline in CD4+ T-cell count (cells/mm3)
HIV RNK < 400 kopija/ml Srednja vrijednost porasta od početne vrijednosti u broju CD4+ T-stanica (stanica/mm3)
Cmax: ↑ 5-fold
Cmax: ↑ 5 puta
Cmax: ↑ 6-fold
Cmax: ↑ 6 puta
• non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI; engl. non-nucleoside reverse transcriptase inhibitor)
All patients were non-nucleoside reverse transcriptase inhibitor naïve.
Nijedan bolesnik nije prethodno primao nenukleozidne inhibitore reverzne transkriptaze.
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. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, refer to the dosing guideline tables below.
Doza Kaletra tableta za odrasle (400/100 mg dvaput na dan) može se koristiti kod djece s 40 kg ili više ili s površinom tijela (PT)* većom od 1,4 m2.
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).
Na početku je ispitivanja medijan broja CD4 stanica u plazmi iznosio 349 stanica/mm³ (raspon 72 do 807 stanica/mm³), a medijan HIV-1 RNK u plazmi 4,0 log10 kopija/ml (raspon od 2,9 do 5,8 log10 kopija/ml).
Patients with prior antiretroviral therapy
Bolesnici koji su već ranije primali antiretrovirusnu terapiju
Read the package leaflet before use.
Pažljivo pročitajte cijelu uputu prije nego
Patients were randomised to either 230 mg lopinavir/57.5 mg ritonavir per m2 or 300 mg lopinavir/75 mg ritonavir per m2. Naïve patients also received nucleoside reverse transcriptase inhibitors.
Bolesnici su randomizirani u dvije skupine, od kojih je jedna primala 230 mg lopinavira/57,5 mg ritonavira po m², a druga 300 mg lopinavira/75 mg ritonavira po m².
Consequently, concomitant administration of Kaletra and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
osim ako očekivana korist od liječenja ne nadmašuje rizik od sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
At entry, median (range) HIV-1 RNA was 6.0 (4.7-7.2) log10 copies/ml and median (range) CD4+T-cell percentage was
Medijan (raspon) vrijednosti HIV-1 RNK pri uključivanju u ispitivanje iznosio je 6,0 (4,7-7,2) log10 kopija/ml, dok je medijan (raspon) postotka CD4+ T-stanica iznosio 41 (16-59).
A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Cmax: ↔ Mogući je izraženiji učinak na izloženost bedakilinu u plazmi tijekom produljene istodobne primjene s lopinavirom/ritonavirom.
Kaletra is also supplied as 200 mg/50 mg film-coated tablets.
Kaletra je također dostupna u obliku 200 mg/50 mg filmom obloženih tableta.
Film-coated tablet Yellow debossed with [Abbott logo] and “KA”.
Filmom obložena tableta Žuta, s utisnutim [logotipom Abbotta] i oznakom “KA”.
The use of avanafil with Kaletra is contraindicated (see section 4.3).
Primjena avanafila s lijekom Kaletra je kontraindicirana (vidjeti dio 4.3).
Kaletra 100 mg/25 mg film-coated tablets
Kaletra 100 mg/25 mg filmom obložene tablete
Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Značajno povećane koncentracije u plazmi zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Kaletra must not be administered once daily in combination with amprenavir.
U kombinaciji s amprenavirom Kaletra se ne smije davati jednom dnevno.
Please refer to the Kaletra 100 mg/25 mg film-coated tablets Summary of Product Characteristics.
Molimo pogledajte sažetak opisa svojstava lijeka za Kaletra 100 mg/25 mg filmom obložene tablete.
Due to CYP3A4 inhibition by lopinavir/ritonavir.
Zbog inhibicije CYP3A4 lopinavirom/ritonavirom.
It is important to note that cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Važno je napomenuti da je u bolesnika koji su uzimali lijek Kaletra bilo i prijava pankreatitisa,
Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.
Svaka filmom obložena tableta sadrži 100 mg lopinavira u kombinaciji s 25 mg ritonavira kao farmakokinetičkog pojačivača.
Kaletra film-coated tablets are pale yellow debossed with [Abbott logo] and “KC”.
Kaletra filmom obložene tablete su svijetlo žute boje s utisnutim [logotipom Abbotta] i oznakom “KC”.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of alfuzosin are expected to increase.
Zbog inhibicije CYP3A lopinavirom/ritonavirom, očekuje se povećanje koncentracije alfuzosina.
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Svaka filmom obložena tableta sadrži 200 mg lopinavira u kombinaciji s 50 mg ritonavira kao farmakokinetičkog pojačivača.
Thereby, increasing the risk of serious arrhythmias from this agent (see section 4.5).
Time je povišen rizik od ozbiljnih aritmija uzrokovanih ovom tvari (vidjeti dio 4.5).
Co-administration of abemaciclib and Kaletra should be avoided.
Potrebno je izbjegavati istodobnu primjenu abemacikliba i lijeka Kaletra.
• anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);
ibrutinib, venetoklaks, većina inhibitora tirozin kinaze kao što su dasatinib i nilotinib, ali i vinkristin i vinblastin);
Increased plasma concentrations of colchicine.
Povišena koncentracija kolhicina u plazmi.
Kaletra tablets must be swallowed whole and not chewed, broken or crushed.
Kaletra tablete moraju se progutati cijele, ne smiju se žvakati, lomiti ili drobiti.
Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions.
Provjerite sažetak opisa svojstava lijeka Kaletra oralne otopine za upute o doziranju oralne otopine.
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).
Srednja početna vrijednost CD4+ T-stanica je bila 254 stanica/mm³ (raspon: 4 do 952 stanica/mm³) i srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,3 log10 kopija/ml (raspon: 1,7 do 6,6 log10 kopija/ml).
Kaletra (80 mg + 20 mg) / ml oral solution
Kaletra (80 mg + 20 mg) / ml oralna otopina
Hepatic Insufficiency
Insuficijencija jetre
Antidepressants and Anxiolytics Trazodone single dose
Antidepresivi i anksiolitici Trazodon u jednokratnoj dozi (Ritonavir, 200 mg BID)
Clinical monitoring of antiviral efficacy is recommended when these medicines are concomitantly administered with Kaletra.
Kada se ti lijekovi daju istodobno s lijekom Kaletra preporučuje se kliničko praćenje protuvirusne djelotvornosti.
Furthermore, rare increases in PR interval have been reported during Kaletra therapy (see section 4.4).
PR-intervala pri uzimanju lijeka Kaletra (vidjeti dio 4.4).
Monitor for ADRs related to ceritinib.
Nadzirati bolesnike zbog mogućih nuspojava povezanih s ceritinibom.
Coombs-negative anisocytosis and poikilocytosis were observed in rats, but not in mice or dogs.
U štakora, no ne i u miševa i pasa, uočene su anizocitoza i poikilocitoza negativne na Coombsov test.
• Kaletra tablets can be taken with or without food.
• Kaletra tablete mogu se uzimati neovisno o uzimanju hrane.
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU 100 mg/25 mg tablete - naljepnica na boci
Kaletra film-coated tablets are yellow debossed with [Abbott logo] and “KA”.
Kaletra filmom obložene tablete su žute boje s utisnutim [logotipom Abbotta] i oznakom “KA”.
Kaletra must not be administered once daily in combination with efavirenz.
U kombinaciji s efavirenzom Kaletra se ne smije davati jednom dnevno.
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.
Kaletra je indicirana za liječenje odraslih, adolescenata i djece starije od 2 godine inficiranih virusom humane imunodeficijencije (HIV-1), u kombinaciji s ostalim antiretrovirusnim lijekovima.
Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5).
Povišena koncentracija neratiniba u plazmi, što može povećati mogućnost nastupa ozbiljnih i/ili po život opasnih reakcija (vidjeti dio 4.5).
• inflammation of the pancreas;
• zatajenje bubrega;
Caution should be exercised and reduced doses should be considered when Kaletra is co-administered with rosuvastatin (see section 4.4).
Kada se Kaletra daje istodobno s rosuvastatinom nužan je oprez i mora se razmotriti smanjenje doza (vidjeti dio 4.4).
Each ml contains: lopinavir 80 mg and ritonavir 20 mg.
Svaki ml sadrži: 80 mg lopinavira i 20 mg ritonavira.
AUC: ↑ 13-fold
AUC: ↑ 13 puta
Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5).
Time je povišen rizik od ozbiljnih aritmija uzrokovanih ovim tvarima (vidjeti dio 4.5).
All patients converted to open-label Kaletra at the 400/100 mg twice daily dose between week 48 and week 72.
Između 48. i 72. tjedna svi bolesnici prešli su na otvorenu primjenu lijeka Kaletra 400/100 mg dva puta dnevno.
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.
A i B liječenih inhibitorima proteaze zabilježeno je pojačano krvarenje, uključujući spontano stvaranje kožnih hematoma i hemartroze.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase.
Zbog inhibicije CYP3A lopinavirom/ritonavirom, očekuje se povećanje koncentracija lomitapida.
Collar
Obruč
Each ml of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir.
Svaki ml Kaletra oralne otopine sadrži 80 mg lopinavira i 20 mg ritonavira.
Co-administration of Kaletra with tadalafil is not recommended.
Istodobna primjena lijeka Kaletra i tadalafila nije preporučena.
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
− 3, 4 − 5, 6 − 7 i 8 − 10 mutacija na mjestima gore navedenih aminokiselina bio je, redom, 0,8; 2,7;
Kaletra 200 mg/50 mg film-coated tablets
Kaletra 200 mg/50 mg filmom obložene tablete
M97-765 is a randomised, double-blind trial evaluating Kaletra at two dose levels (400/100 mg and 400/200 mg, both twice daily) plus nevirapine (200 mg twice daily) and two nucleoside reverse transcriptase inhibitors in 70 single protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.
400/200 mg dvaput na dan u oba slučaja) plus nevirapin (200 mg dvaput na dan) te dvaju nukleozidnih inhibitora reverzne transkriptaze u 70 bolesnika koji su prethodno primali jedan inhibitor proteaze, ali ne i nenukleozidne inhibitore reverzne transkriptaze.
CYP3A4 inhibition likely due to lopinavir/ritonavir.
Moguća je inhibicija CYP3A4 zbog učinka lopinavira/ritonavira.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase.
Zbog inhibicije CYP3A lopinavirom/ritonavirom mogu se očekivati povećane koncentracije kvetiapina.
Kaletra must not be administered once daily in combination with nevirapine.
U kombinaciji s nevirapinom Kaletra se ne smije davati jednom dnevno.
The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Farmakokinetički pokazatelji lopinavira u stanju dinamičke ravnoteže, u ispitivanju pri višekratnim dozama lopinavira/ritonavira od 400/100 mg dvaput na dan u bolesnika zaraženih HIV-om, s blagim do umjerenim oštećenjem funkcije jetre uspoređeni su s onima u bolesnika zaraženih HIV-om u kojih je funkcija jetre bila uredna.
AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
AUC: ↑ 13 puta Zbog inhibicije CYP3A lopinavirom/ritonavirom.
Ombitasvir/paritaprevir/ritonavir with or without dasabuvir
Ombitasvir/paritaprevir/ritonavir u kombinaciji s dasabuvirom ili bez njega
Due to CYP3A inhibition by lopinavir/ritonavir.
Zbog inhibicije CYP3A lopinavirom/ritonavirom.
Cmax Cpredose μg /mL
Cprije početka liječenja μg /mL
It is not recommended to co-administer Kaletra and simeprevir.
Ne preporučuje se istodobna primjena lijeka Kaletra i simeprevira.
Film-coated tablet Pale yellow debossed with [Abbott logo] and “KC”.
Filmom obložena tableta Blijedožute boje, s utisnutim [logotipom Abbotta] i oznakom “KC”.
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.
Kaletra je indicirana za liječenje odraslih, adolescenata i djece u dobi od 14 dana i starije inficiranih virusom humane imunodeficijencije (HIV-1), u kombinaciji s ostalim antiretrovirusnim lijekovima.
Moderate increases in clarithromycin AUC are expected due to CYP3A inhibition by lopinavir/ritonavir.
Očekuje se umjereno povećanje AUC zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Concentrations are expected to increase due to CYP3A inhibition by lopinavir/ritonavir.
Očekuje se povećanje koncentracija zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Mean baseline CD4+ T-cell count was 838 cells/mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ml.
Srednja početna vrijednost broja CD4+ T-stanica iznosila je na početku terapije 838 stanica/ mm3, a srednja početna vrijednost broja kopija HIV-1 RNK iznosila je 4,7 log10 kopija/ml.
Each ml contains lopinavir 80 mg and ritonavir 20 mg.
Svaki ml sadrži 80 mg lopinavira i 20 mg ritonavira.
Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Kaletra.
Pri primjeni ovih lijekova istodobno s lijekom Kaletra preporučuje se kliničko praćenje liječenja i nuspojava.
Serum concentrations of apalutamide may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Serumske koncentracije apalutamida mogu biti povišene zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Concentrations may be reduced due to induction of CYP3A by the herbal preparation St John's wort.
Koncentracije mogu biti smanjene zbog indukcijskog učinka gospine trave na CYP3A.
Medicinal product class
FARMACEUTSKI PODACI
The adverse reactions are displayed by system organ class.
Nuspojave su navedene prema organskim sustavima.
Increased plasma concentrations of sildenafil.
Povišena koncentracija sildenafila u plazmi.
Amiodarone, Dronedarone Amiodarone, Dronedarone: Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Felodipin, nifedipin, nikardipin: Koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
Kaletra must not be administered once daily in combination with phenytoin.
U kombinaciji s fenitoinom Kaletra se ne smije davati jednom dnevno.
• tremor;
• nevoljno drhtanje;
BID)
beklometazon).
• antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir );
(npr. glekaprevir/pibrentasvir, simeprevir i sofosbuvir/velpatasvir/voksilaprevir);
Cmax: ↓ 47%
Cmin: ↓ 70% Cmax: ↓ 47%
Analysis of resistance in PI-experienced patients
Analiza rezistencije u bolesnika koji nisu primali antitretrovirusne lijekove
− digoxin;
• proljev;
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. 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 djecu lakšu od 40 kg i površine tijela od 0,5 do 1,4 m² koja mogu progutati tabletu, koristite sažetak opisa svojstava lijeka za Kaletra tablete 100 mg/25 mg.
• diarrhoea;
• hemoroidi;
Use the 5 ml oral dosing syringe to prepare a dose.
Za odmjeravanje doze upotrijebite štrcaljku od 5 ml za primjenu kroz usta.
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Svaki mililitar lijeka Kaletra sadrži 80 mg lopinavira i 20 mg ritonavira.
The use of vardenafil with Kaletra is contraindicated (see section 4.3).
Istodobna primjena vardenafila i lijeka Kaletra je kontraindicirana (vidjeti dio 4.3).
Concentrations may be decreased due to CYP3A induction by dexamethasone.
Koncentracije mogu biti smanjene zbog indukcijskog učinka deksametazona na
Opioids
Hemofilija
Caution should be exercised in administering carbamazepine or phenobarbital with Kaletra.
Pri primjeni karbamazepina ili fenobarbitala istodobno s lijekom Kaletra nužan je oprez.