natgillin/translations-raw huggingface dataset:
Outcomes at Week 360: Study M97-720
Rezultati v 360.tednu: Študija M97-720 Kaletra (N=100)
Co-administration of abemaciclib and Kaletra should be avoided.
Sočasni uporabi abemacikliba in zdravila Kaletra se je potrebno izogniti.
Antianginal
Antiaritmiki
Kaletra is also supplied as 200 mg/50 mg film-coated tablets.
Zdravilo Kaletra je na voljo tudi kot 200/50 mg filmsko obložene tablete.
• upper respiratory tract infection.
- driska; - slabost; - okužbe zgornjih dihal.
• Thirst, frequent urination, blurred vision or weight loss as this may indicate raised sugar levels in the blood.
- Žejo, pogosto uriniranje, zamegljen vid ali izgubo telesne mase.
Increased plasma concentrations of colchicine.
Večja koncentracija kolhicina v plazmi.
• If the ‘ml' mark on the collar is more than the prescribed dose, push the plunger to the prescribed dose.
• Če oznaka z ‘ml' na obroču kaže več kot predpisani odmerek, pritisnite na bat do predpisanega odmerka.
Acid reducing agents Omeprazole (40 mg QD)
Zdravila za uravnavanje izločanja želodčne kisline Omeprazol (40 mg enkrat na dan)
Kaletra tablets must be swallowed whole and not chewed, broken or crushed.
Tablete zdravila Kaletra mora bolnik zaužiti cele in jih ne sme žvečiti, lomiti ali drobiti.
Patients who exhibit these signs or symptoms should be evaluated and Kaletra therapy should be suspended if a diagnosis of pancreatitis is made (see section 4.8).
Če se diagnoza pankreatitisa potrdi, je treba zdravljenje z zdravilom Kaletra prekiniti (glejte poglavje 4.8).
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.
Zdravilo Kaletra je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starih14 dni in več, okuženih z virusom (HIV-1), ki povzroča imunsko pomanjkljivost.
Serum concentrations may be increased due to CYP3A inhibition by ritonavir.
Serumske koncentracije se lahko povečajo zaradi zavrtja CYP3A z ritonavirjem.
Co-administration of increased doses of fosamprenavir (1400 mg BID) with Kaletra (533/133 mg BID) to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ritonavir.
Bolnikom, ki so že dobivali zaviralce proteaz, je sočasna uporaba večjih odmerkov fosamprenavirja (1400 mg dvakrat na dan) z zdravilom Kaletra 533/133 mg dvakrat na dan povečala incidenco neželenih učinkov na prebavila in zvišanja trigliceridov s kombinirano shemo.
Uncommon Atherosclerosis such as myocardial infarction, atrioventricular block, tricuspid valve incompetence
Srčne bolezni občasni ateroskleroza kot je miokardni infarkt, atrioventrikularni blok, motnje delovanja trikuspidalne zaklopke
− If you get any effects, talk to your doctor or pharmacist.
- Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Phenytoin levels should be monitored when co-administering with Kaletra.
Kaletra je treba kontrolirati koncentracijo fenitoina.
Increased plasma concentrations of ranolazine which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Večja koncentracija ranolazina v plazmi, ki lahko poveča možnost za resne in/ali življenje ogrožajoče reakcije (glejte poglavje 4.5).
Kaletra must not be administered once daily in combination with amprenavir.
Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji z amprenavirjem.
Colloidal anhydrous silica Macrogols type 3350 (Polyethylene glycol 3350) Yellow ferric oxide E172
Filmska obloga: polivinilalkohol titanov dioksid smukec makrogol 3350 (polietilenglikol 3350) rumeni železov oksid E172
Always take this medicine exactly as your doctor has told you.
- Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
For children 14 days and older and weighing up to 15 kg
Koliko zdravila Kaletra naj uporabim in kdaj Za otroke, stare 14 dni in več, ki tehtajo do 15 kg
Hypersensitivity to the active substances or to any of the excipients.
Preobčutljivost na učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
Patients were administered either the tablet or the soft capsule formulation for 8 weeks, after which all patients were administered the tablet formulation once daily or twice daily for the remainder of the study.
Bolniki so 8 tednov dobivali bodisi tablete bodisi mehke kapsule; po tem obdobju so vsi bolniki med preostalim obdobjem študije dobivali tablete enkrat na dan ali dvakrat na dan. Bolniki so dobivali emtricitabin 200 mg enkrat na dan in tenofovir DF 300 mg enkrat na dan (ekvivalentno 245 mg dizoproksiltenofovirata).
Increased plasma concentrations of sildenafil.
Večja koncentracija sildenafila v plazmi.
Kaletra must not be administered once daily in combination with phenytoin.
Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji s fenitoinom.
HIV RNA < 50 copies/ml (ITT)*
HIV RNA < 400 kopij/ml (ITT)* HIV RNA < 50 kopij/ml (ITT)*
Kaletra 200 mg/50 mg film-coated tablets
Kaletra 200 mg/50 mg filmsko obložene tablete
Medicinal product class
FARMAKOLOŠKE LASTNOSTI
Kaletra film-coated tablets are yellow debossed with [Abbott logo] and “KA”.
Filmsko obložene tablete zdravila Kaletra so rumene in imajo vtisnjeni oznaki [Abbottov logo] in "KA".
Thereby, increasing the risk of serious arrhythmias from this agent (see section 4.5).
Zaradi tega večje tveganje resnih motenj srčnega ritma, povezanih s tem zdravilom (glejte poglavje 4.5).
Pregnant or breast-feeding mothers should not take Kaletra oral solution unless specifically directed by the doctor.
Nosečnice ali doječe matere ne smejo jemati zdravila
Each ml contains: lopinavir 80 mg and ritonavir 20 mg.
1 ml vsebuje: 80 mg lopinavirja in 20 mg ritonavirja.
When co-administered with phenytoin, an increase of Kaletra dosage may be envisaged.
Med sočasno uporabo s fenitoinom je treba predvideti povečanje odmerka zdravila
Anticancer agents Abemaciclib
Zdravila proti raku Abemaciklib
The use of avanafil with Kaletra is contraindicated (see section 4.3).
Uporaba avanafila z zdravilom Kaletra je kontraindicirana (glejte poglavje 4.3).
Concentrations may be decreased due to CYP3A induction by carbamazepine and phenobarbital.
Lopinavir: zaradi indukcije CYP3A s karbamazepinom oz. fenobarbitalom se koncentracija lahko zniža.
Particular caution should be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels.
kajti pričakovati je treba, da akutno zavrtje Pgp z ritonavirjem bistveno zviša koncentracijo digoksina.
BID)
Kaletra).
Pancreatitis1, vomiting, gastrooesophageal reflux disease, gastroenteritis and colitis, abdominal pain (upper and lower), abdominal distension, dyspepsia, haemorrhoids, flatulence
Bolezni prebavil zelo pogosti driska, slabost pogosti pankreatitis1, bruhanje, gastroezofagealna refluksna bolezen, gastroenteritis in kolitis, 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
AUC: ↑ 2.17-fold Cmax: ↑ 2.04-fold Ctrough: ↑ 2.36-fold (inhibition of CYP3A/efflux transporters)
AUC: ↑ 2,17-krat Cmax: ↑ 2,04-krat Ctrough: ↑ 2,36-krat
See adult dosage recommendation *weight based dosing recommendations are based on limited data ** the volume (ml) of oral solution represents the average dose for the weight range
*smernice za odmerjanje na osnovi telesne mase temeljijo na omejenih podatkih
Careful monitoring of adverse effects (notably respiratory depression but also sedation) is recommended when fentanyl is concomitantly administered with Kaletra.
V primeru istočasnega jemanja fentanila in zdravila Kaletra se priporoča skrbno spremljanje neželenih učinkov (predvsem dihalne stiske, pa tudi sedacije).
GI motility agent Cisapride
Zdravilo za zdravljenje motenj motilitete prebavil Cisaprid
The increased digoxin level may lessen over time as P-gp induction develops.
Zvišana koncentracija digoksina se sčasoma lahko zniža,
Use the 5 ml oral dosing syringe to prepare a dose.
Za pripravo odmerka uporavite 5-ml brizgo za peroralno dajanje.
• HIV-1 integrase inhibitor (e.g. raltegravir);
- zdravila, ki zavirajo HIV CCR5 (npr. maravirok); - zdravila, ki zavirajo HIV-1 integrazo (npr. raltegravir);
AUC: ↑ 5-fold
AUC: ↑ 5-krat
Film-coated tablet Yellow debossed with [Abbott logo] and “KA”.
filmsko obložena tableta Rumena, z vtisnjenima oznakama [Abbottov logo] in "KA".
Tablet coating
Zeliščna zdravila
• Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition.
Veliko zvečanje količine trigliceridov (vrste maščob v krvi) velja za dejavnik tveganja za to bolezen.
Interaction table
Preglednica medsebojnih delovanj
• kidney failure;
- odpoved ledvic;
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
1 ml zdravila Kaletra vsebuje 80 mg lopinavirja in 20 mg ritonavirja.
• Risk Management Plan (RMP)
• Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe,
• elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
zgoraj); - zdravila za zdravljenje tuberkuloze (bedakilin, delamanid); - protivirusna zdravila za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih
Use the 2 ml oral dosing syringe to prepare a dose.
Za pripravo odmerka uporabite 2 ml brizgo za peroralno dajanje.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lurasidone are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij lurasidona.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of pimozide are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij pimozida.
Hepatitis including AST, ALT and GGT increases
Bolezni jeter, žolčnika in žolčevodov pogosti hepatitis, vključno s povišanjem AST, ALT in
Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir, resulting in increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.3 and refer to the venetoclax SmPC).
posledično se poveča tveganje za pojav sindroma tumorske lize pri začetnem odmerjanju in med fazo povečevanja odmerka (glejte poglavje 4.3 in povzetek glavnih značilnosti zdravila za venetoklaks).
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,
The active substances are lopinavir and ritonavir.
Zdravilni učinkovini sta lopinavir in ritonavir.
Each ml contains lopinavir 80 mg and ritonavir 20 mg.
En ml vsebuje 80 mg lopinavirja in 20 mg ritonavirja.
• If the ‘ml' mark on the black ‘O' ring is more than the prescribed dose, push the plunger to the prescribed dose.
• Če je črni obroč na oznaki z ‘ml', ki je večja od predpisanega odmerka, pritisnite na bat do predpisanega odmerka.
AUC: ↑ 5.7-fold Cmax: ↑ 3.5-fold
AUC: ↑ 5,7-krat Cmax: ↑ 3,5-krat
AUC: ↑ 153%
AUC: ↑ 153 % Cmax: ↑ 55 %
Film-coating:
Filmska obloga
Uncommon Creatinine clearance decreased, nephritis, haematuria
Bolezni sečil občasni zmanjšan očistek kreatinina, nefritis,
Due to CYP3A inhibition by lopinavir/ritonavir.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Adverse events of nausea, dizziness, hypotension and syncope were observed following co-administration of trazodone and ritonavir.
Po sočasni uporabi trazodona in ritonavirja so kot neželene učinke zabeležili navzeo, omotico, hipotenzijo in sinkopo.
The concomitant administration with lurasidone is contraindicated (see section 4.3).
Sočasna uporaba z lurasidonom je kontraindicirana (glejte poglavje
Kaletra (80 mg + 20 mg) / ml oral solution
Kaletra (80 mg + 20 mg) / ml peroralna raztopina
Refer to the ceritinib SmPC for dosage adjustment recommendations.
Za priporočila glede prilagoditve odmerjanja glejte povzetek glavnih značilnosti zdravila za ceritinib.
Therefore, concomitant administration of Kaletra with salmeterol is not recommended (see section 4.4).
Kaletra s salmeterolom ni priporočljiva (glejte poglavje
It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir.
Sočasna uporaba zdravila Kaletra in sofosbuvirja/velpatasvirja/
Kaletra oral solution:
Kaletra peroralna raztopina:
Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions.
Za navodila o odmerjanju glejte povzetek glavnih značilnosti zdravila Kaletra peroralna raztopina.
GI motility agent
Zdravilo za motiliteto prebavil
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of alfuzosin are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem je treba pričakovati zvišanje koncentracije alfuzosina.
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - nenormalne sanje;
Digoxin:
Trazodon:
Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5).
saj lahko poveča tveganje resnih aritmij zaradi tega zdravila (glejte poglavje 4.3).
Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5).
Zvišana koncentracija neratiniba v plazmi, ki lahko poveča tveganje za resne in/ali življenje ogrožajoče reakcije (glejte poglavje 4.5).
For larger volumes an alternative pack is available.
Za volumne do 2 ml. Za večje volumne je na voljo drugo pakiranje.
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of ranolazine are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij ranolazina.
All patients converted to open-label Kaletra at the 400/100 mg twice-daily dose between week 48 and week 72.
Vsi bolniki so med 48. in 72. tednom prešli na odprto uporabo zdravila Kaletra v odmerku
• If the ‘ml' mark on the collar is less than the prescribed dose, draw up more solution to the prescribed dose.
• Če je črni obroč na oznaki z ‘ml', ki je manjša od predpisanega odmerka, v brizgo potegnite dodatno raztopino, da dobite predpisani odmerek.
Concentrations may be reduced due to increased glucuronidation by lopinavir/ritonavir.
Zmanjšana izpostavljenost zdravilu Kaletra lahko vodi v v zmanjšanje izpostavljenosti lopinavirju/ritonavirju.
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label
PODATKI NA PRIMARNI OVOJNINI 100 mg/25 mg tablete - nalepka na plastenki
AUC: ↓ 35% Cmin: ↓ 45% Cmax: ↓ 30%
AUC: ↓ 35 % Cmin: ↓ 45 % Cmax: ↓ 30 % Lopinavir :
Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Koncentracije se lahko zvišajo zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3).
povzročijo miopatijo, vključno z rabdomiolizo, je uporaba teh zdravil hkrati z zdravilom Kaletra kontraindicirana (glejte poglavje
− Keep this leaflet.
Glejte poglavje
Sorbitan laurate Colloidal anhydrous silica Sodium stearyl fumarate
Vsebina tablete: kopovidon sorbitan lavrat koloidni brezvodni silicijev dioksid natrijev stearilfumarat
Due to the risk of QTc prolongation associated with DM-6705, if co-administration of delamanid with Kaletra is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid SmPC).
6705 priporočljivo zelo pogosto spremljanje EKG-ja skozi celotno obdobje zdravljenja (glejte poglavje 4.4 in glejte povzetek glavnih značilnosti zdravila za delamanid).
AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
AUC: ↑ 11-krat zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Trazodone: AUC: ↑ 2.4-fold
AUC: ↑ 2,4-krat
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 200 mg/50 mg tablets - Bottle label
PODATKI NA PRIMARNI OVOJNINI 200 mg/50 mg tablete - nalepka na plastenki
Each ml of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir.
1 ml zdravila Kaletra peroralna raztopina vsebuje 80 mg lopinavirja in 20 mg ritonavirja.
There were no reported events of failure attributed to therapy limiting toxicity.
* Neuspeh je definiran kot klinično, imunološko napredovanje bolezni, virološki neuspeh ali toksičnost protiretrovirusnega zdravljenja, ki omejuje shemo zdravljenja.
HIV RNA < 50 copies/ml*†
HIV RNA < 400 kopij/ml* HIV RNA < 50 kopij/ml*†
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij lomitapida.
Caution should be exercised in administering phenytoin with Kaletra.
Pri uporabi fenitoina z zdravilom Kaletra je potrebna previdnost.
The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
18 izolatih v primerjavi z divjim tipom virusa je bil izhodiščno 6,9-krat in po preobratu 63-krat.
Nervous system disorders
- poškodbe perifenih živcev;
AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
AUC: ↑ 7,2-krat Cmax: ↑ 4,7-krat
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Čas nastopa bolezni, o katerem so poročali, je precej spremenljiv in je lahko več mesecev po začetku zdravljenja.
Patients should be monitored closely for a decreased VPA effect when Kaletra and valproic acid or valproate are given concomitantly.
Pri bolnikih z okvarjenim delovanjem jeter ali ledvic je treba klaritromicin hkrati z zdravilom Kaletra uporabljati previdno.
Antidepressants and Anxiolytics Trazodone single dose
Antidepresivi in anksiolitiki Trazodon, enkraten odmerek (Ritonavir, 200 mg dvakrat na dan)
Clinical recommendation concerning co-administration with Kaletra
Klinično priporočilo glede sočasne uporabe z zdravilom
• deep vein inflammation related to a blood clot;
- nekontrolirano tresenje telesa; - zaprtje; - globoka venska tromboza, povezana s krvnimi strdki; - suha usta;
Hepatic impairment
Neželen učinek
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 do 10 bolnikov - vnetje trebušne slinavke;
Haemophilia
hematurija
Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Serumske koncentracije se lahko povečajo zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Anaemia, leucopenia, neutropenia, lymphadenopathy
Bolezni krvi in limfatičnega sistema pogosti anemija, levkopenija, nevtropenija in limfadenopatija
Clarithromycin:
AUC klaritromicina.
Co-administration of encorafenib and Kaletra should be avoided.
Sočasni uporabi enkorafeniba in zdravila Kaletra se je potrebno izogniti.
Posology
Obroč
Package leaflet: Information for the user Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Navodilo za uporabo Kaletra 100 mg/25 mg filmsko obložene tablete lopinavir/ritonavir
Anti-gout
GGT
• antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir);
- elbasvir/grazoprevir (uporablja se za zdravljenje kronične okužbe z virusom hepatitisa C [HCV]); - ombitasvir/paritaprevir/ritonavir z ali brez dasabuvirja (uporablja se za zdravljenje kronične okužbe z virusom hepatitisa C [HCV]); - neratinib (uporablja se za zdravljenje raka dojk); - avanafil ali vardenafil (uporablja se za zdravljenje erektilne disfunkcije);
The pharmacokinetic data from HIV-1 infected pregnant women receiving lopinavir/ritonavir tablets 400/100 mg twice daily are presented in Table 6 (see section 4.2).
400/100 mg tablete dvakrat dnevno, so prikazani v Preglednici 6 (glejte poglavje 4.2).
Increased plasma concentrations of fusidic acid.
Večja koncentracija fusidne kisline v plazmi.
Tip
Bat
Hypersensitivity including urticaria and angioedema
Bolezni imunskega sistema pogosti preobčutljivost vključno z urtikarijo in angioedemom občasni vnetni sindrom imunske rekonstitucije
The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Analiza odpornosti pri bolnikih, izkušenih z zaviralci proteaz Selekcijo odpornosti proti lopinavirju pri bolnikih, pri katerih je bilo predhodno zdravljenje z zaviralcem proteaz neuspešno, so opredelili z analizo longitudinalnih izolatov 19 bolnikov, izkušenih z zaviralci proteaz, in sicer v dveh študijah II.
Outcomes at Week 24: Study M97-765
Rezultati v 24. tednu: Študija M97-765 Kaletra 400/100 mg (N=36)
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase.
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem je pričakovati povišane koncentracije kvetiapina.
Barrel Tip
Cev Konica
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone.
Pri bolnikih, ki so dobivali ritonavir in inhalirani ali intranazalni flutikazonpropionat, so opisani sistemski učinki kortikosteroidov, vključno s Cushingovim sindromom in adrenalno supresijo.
Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Bolezni kože in podkožja pogosti izpuščaj vključno z makropapularnim izpuščajem, dermatitis/izpuščaj vključno z ekcemom in seboroičnim dermatitisom, nočno potenje, pruritus občasni alopecija, kapilaritis, vaskulitis neznana pogostnost
Herbal products
Zdravila rastlinskega izvora
Package leaflet: Information for the user Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Navodilo za uporabo Kaletra 200 mg/50 mg filmsko obložene tablete lopinavir/ritonavir
Kaletra must not be co-administered with oral midazolam (see section 4.3), whereas caution should be used with co-administration of Kaletra and parenteral midazolam.
4.3), v primeru sočasne uporabe zdravila Kaletra in parenteralnega midazolama pa je potrebna previdnost.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipacks of 120 (3 cartons of 40 film-coated 200 mg/50 mg film-coated tablets) - including the blue box
Škatla z multipakiranji po 120 tablet (3 škatle s 40 filmsko obloženimi tabletami) - vključno z modrim okencem
− calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine);
zaviralci kalcijevih kanalčkov (npr. felodipin, nifedipin, nikardipin); zdravila za urejanje srčnega ritma (npr. bepridil, sistemski lidokain, kinidin);