natgillin/translations-raw huggingface dataset:
Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Vsebuje: alkohol (42 % v/v, glejte navodilo za uporabo), visokofruktozni koruzni sirup, propilenglikol, glicerol, makrogolglicerol 40 hidrogenirano ricinusovo olje , kalij (kot kalijev acesulfamat).
• inflammation of blood vessels and capillaries;
- vnetje krvnih žil in kapilar;
Abacavir, Zidovudine Abacavir, Zidovudine: Concentrations may be reduced due to increased glucuronidation by lopinavir/ritonavir.
Abakavir, zidovudin Abakavir, zidovudin: zaradi povečane glukuronidacije zaradi lopinavirja/ritonavirja se koncentracija lahko zniža.
Increased plasma concentrations of amiodarone and dronedarone.
Večja koncentracija amiodarona in dronedarona v plazmi.
Vasodilating agents Bosentan
Vazodilatacijska zdravila Bosentan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 200 mg/50 mg tablets - Blister of 8 film-coated tablets or Blister of 12 film-coated tablets
200 mg/50 mg tablete - pretisni omot z 8 filmsko obloženimi tabletami ali pretisni omot z 12 filmsko obloženimi tabletami
AUC: ↑ 2-fold Cmax: ↑ 5-fold
AUC: ↑ 2-krat Cmax: ↑ 5-krat
Ritonavir inhibits the metabolism of lopinavir, thereby increasing the plasma levels of lopinavir.
Ritonavir zavira presnovo lopinavirja in tako zvečuje koncentracijo lopinavirja v plazmi.
Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Rilpivirin (Lopinavir/ritonavir kapsula 400/100 mg dvakrat na dan)
Kaletra pharmacokinetics have not been studied in patients with renal insufficiency; however, since the renal clearance of lopinavir is negligible, a decrease in total body clearance is not expected in patients with renal insufficiency.
A ker je ledvični očistek lopinavirja zanemarljiv, pri bolnikih z ledvično insuficienco ni pričakovati zmanjšanja celotnega telesnega očistka.
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Kaletra (80 mg + 20 mg) / ml peroralna raztopina (lopinavir + ritonavir)
Concomitant use of neratinib with Kaletra is contraindicated due to serious and/or life-threatening potential reactions including hepatotoxicity (see section 4.3).
Sočasna uporaba neratiniba in zdravila Kaletra je kontraindicirana zaradi možnih resnih in/ali življenje ogrožajočih reakcij, vključno s hepatotoksičnostjo (glejte poglavje 4.3).
AUC: ↑ 13-fold
AUC: ↑ 13-krat
Virologic Response of Study Subjects at Week 48 Study 802 QD BID Difference [95% CI]
Virološki odziv preiskovancev v študiji 48. teden študije 802 Enkrat na dan
Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Večja koncentracija vardenafila v plazmi (glejte poglavji 4.4 in 4.5)
The pharmacokinetics of Kaletra oral solution 300/75 mg/m2 twice daily and 230/57.5 mg/m2 twice daily have been studied in a total of 53 paediatric patients, ranging in age from 6 months to 12 years.
Farmakokinetiko peroralne raztopine zdravila Kaletra 300/75 mg/m2 dvakrat na dan in 230/57,5 mg/m2 dvakrat na dan so raziskali pri skupaj 53 pediatričnih bolnikih, starih od 6 mesecev do 12 let.
b. Tabulated list of adverse reactions
b. Seznam neželenih učinkov v preglednici
Concomitant administration of Kaletra and astemizole and terfenadine is contraindicated as it may increase the risk of serious arrhythmias from these agents (see section 4.3).
Sočasna uporaba zdravila Kaletra z astemizolom in terfenadinom je kontraindicirana, ker lahko poveča tveganje resnih aritmij zaradi teh zdravil (glejte poglavje
• If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine because it contains propylene glycol and alcohol.
- Če ste noseči ali dojite, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo,
Glecaprevir/pibrentasvir Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
Glekaprevir/pibrentasvir Serumske koncentracije se lahko zvišajo zaradi zavrtja Pglikoproteina, BCRP in OATP1B z lopinavirjem/ritonavirjem.
• Your doctor will decide the right dose based on the child's height and weight.
- Pravi odmerek za otroka bo zdravnik določil na osnovi otrokove višine in telesne mase.
Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Dogodki z neznano pogostnostjo so bili opaženi v obdobju spremljanja zdravila po prihodu na trg.
During in vitro studies, cloned human cardiac potassium channels (HERG) were inhibited by 30% at the highest concentrations of lopinavir/ritonavir tested, corresponding to a lopinavir exposure 7-fold total and 15-fold free peak plasma levels achieved in humans at the maximum recommended therapeutic dose.
Med študijami in vitro so največje preizkušene koncentracije lopinavirja/ritonavirja zavrle klonirane človeške srčne kanale za kalij (HERG) za 30 %; izpostavljenost ustreza izpostavljenosti lopinavirju ob
• ranolazine (used to treat chronic chest pain [angina]);
- ranolazin (uporablja se za zdravljenje kronične bolečine v prsnem košu [angina pektoris]); - cisaprid (uporablja se za lajšanje določenih težav z želodcem);
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
*Telesno površino lahko izračunamo po enačbi telesna površina (m2) = √ (višina (cm) X telesna masa (kg) / 3600)
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.
Pediatrična populacija (od 2. leta dalje) Odmerek tablet zdravila 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. Za otroke, ki tehtajo manj kot 40 kg ali imajo telesno površino med 0,5 in 1,4 m2 in zmorejo pogoltniti tablete, glejte spodnji tabeli, ki prikazujeta smernice za odmerjanje.
In adult patients, in cases where once-daily dosing is considered necessary for the management of the patient, Kaletra tablets may be administered as 800/200 mg (four 200/50 mg tablets) once daily with or without food.
pride pri odraslih bolnikih v poštev uporaba tablet zdravila Kaletra v odmerku 800/200 mg (štiri tablete 200/50 mg) enkrat na dan s hrano ali brez nje.
Concomitant administration of Kaletra with colchicine in patients with renal and/or hepatic impairment is contraindicated due to a potential increase of colchicine-related serious and/or life-threatening reactions such as neuromuscular toxicity (including rhabdomyolysis) (see sections 4.3 and 4.4).
Sočasna uporaba zdravila Kaletra s kolhicinom je kontraindicirana pri bolnikih z okvaro ledvic in/ali jeter, ker obstaja možnost povečanja resnih in/ali življenjsko ogrožajočih reakcij povezanih s kolhicinom kot je živčno-mišična toksičnost (vključno z rabdomiolizo) (glejte poglavji 4.3 in 4.4).
Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
primerov srčnega bloka druge ali tretje stopnje pa ni bilo (glejte poglavje 4.4).
Increased plasma concentrations of venetoclax.
Zvišana koncentracija venetoklaksa v plazmi.
• For children, your doctor will decide the right dose (number of tablets) based on the child's height and weight.
Uporaba pri otrocih, starih 2 leti in več - Pravi odmerek (število tablet) za otroka bo zdravnik določil na osnovi otrokove višine in telesne mase.
Effects on drug levels Geometric Mean Change (%) in AUC, Cmax, Cmin
Geometrična srednja sprememba (%) AUC,
Kaletra contains polyoxyl 40 hydrogenated castor oil.
Zdravilo Kaletra vsebuje makrogolglicerol hidroksistearat 40.
It is recommended that INR (international normalised ratio) be monitored.
(internacionalno normalizirano razmerje).
Saquinavir 1000 mg BID
Sakvinavir 1000 mg dvakrat na dan
120 ml (2 bottles x 60 ml) oral solution with two 2 ml oral dosing syringes.
120 ml (2 plastenki po 60 ml) peroralne raztopine z dvema 2 ml brizgama za peroralno dajanje
Caution should be exercised in administering Kaletra with bosentan.
Pri uporabi zdravila Kaletra z bosentanom je potrebna previdnost.
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.
povečanjem IC50 v izhodiščnih izolatih za 1,9-krat in izolatih po preobratu za 1,8-krat v primerjavi z divjim tipom virusa.
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.
Pediatrična populacija (od 2. leta dalje) Odmerek tablet zdravila 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. Za otroke, ki tehtajo manj kot 40 kg ali imajo telesno površino med 0,5 in 1,4 m2 ter zmorejo pogoltniti tablete, glejte povzetek glavnih značilnosti zdravila Kaletra 100 mg/25 mg filmsko obložene tablete.
• abnormally high level of bilirubin (a pigment produced from the breakdown of red blood cells)
- povečan apetit; - nenormalno visok nivo bilirubina (pigment, ki nastaja ob razpadu rdečih krvničk) v krvi;
Concomitant administration of glecaprevir/pibrentasvir and Kaletra is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Sočasna uporaba glekaprevirja/pibrentasvirja in zdravila Kaletra ni priporočljiva zaradi povečanega tveganja za povišanje alanin transaminaze
The lopinavir mean steadystate AUC, Cmax, and Cmin were 72.6 ± 31.1 µg•h/ml, 8.2 ± 2.9 µg/ml and 3.4 ± 2.1 µg/ml, respectively after Kaletra oral solution 230/57.5 mg/m2 twice daily without nevirapine (n=12), and were 85.8 ± 36.9 µg•h/ml, 10.0 ± 3.3 µg/ml and 3.6 ± 3.5 µg/ml, respectively after 300/75 mg/m2 twice daily with nevirapine (n=12).
3,4 ± 2,1 µg/ml po peroralni raztopini zdravila Kaletra 230/57,5 mg/m2 dvakrat na dan brez nevirapina (n = 12) ter 85,8 ± 36,9 µg•h/ml, 10,0 ± 3,3 µg/ml in 3,6 ± 3,5 µg/ml po 300/75 mg/m2 dvakrat na dan z nevirapinom (n = 12).
Myalgia, musculoskeletal pain including arthralgia and back pain, muscle disorders such as weakness and spasms
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mialgija, mišično-skeletne bolečine vključno z artralgijo in bolečinami v hrbtu, bolezni mišic kot je šibkost in krči občasni rabdomioliza, osteonekroza
Caution should be exercised in administering afatinib with Kaletra.
Pri uporabi afatiniba z zdravilom Kaletra je potrebna previdnost.
Increased plasma concentrations of cisapride.
Večja koncentracija cisaprida v plazmi.
The 230/57.5 mg/m2 twice daily regimen without nevirapine and the 300/75 mg/m2 twice daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice daily regimen without nevirapine.
Shemi 230/57,5 mg/m2 dvakrat na dan brez nevirapina in 300/75 mg/m2 dvakrat na dan z nevirapinom sta v plazmi zagotovili koncentracijo lopinavirja, podobno tisti pri odraslih bolnikih, ki so dobivali zdravilo po shemi 400/100 mg dvakrat na dan brez nevirapina.
Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, 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, levomenthol.
prečiščeno vodo glicerol povidon aromo Magnasweet-110 (mešanica monoamonijevega glicirizinata in glicerola) aromo vanilije (vsebuje p-hidroksibenzojsko kislino, p-hidroksibenzaldehid, vanilinsko kislino, vanilin, heliotropin, etilvanilin) makrogolglicerol 40 hidrogenirano ricinusovo olje aromo sladkorne pene (vsebuje etilmaltol, etilvanilin, acetoin, dihidrokumarin, propilenglikol) kalijev acesulfamat natrijev saharinat natrijev klorid eterično olje poprove mete natrijev citrat citronsko kislino levomentol
The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/100 mg twice daily and supratherapeutic 800/200 mg twice daily LPV/r, respectively.
Največja povprečna razlika (95 % zgornja meja zaupanja) QTcF v primerjavi s placebom je bila 3,6 (6,3) med uporabo lopinavirja/ritonavirja 400/100 mg dvakrat na dan in 13,1 (15,8) med uporabo supraterapevtskega odmerka lopinavirja/ritonavirja 800/200 mg dvakrat na dan. K podaljšanju intervala QT pripomore podaljšanje intervala QRS s 6 ms na 9,5 ms, ki ga povzročijo veliki odmerki lopinavirja/ritonavirja (800/200 mg dvakrat na dan).
However, dialysis can remove both alcohol and propylene glycol in the case of overdose with Kaletra oral solution.
Vendar pa lahko v primeru prevelikega odmerjanja zdravila Kaletra peroralna raztopina dializa odstrani tako alkohol kot propilenglikol.
(see Other medicines and Kaletra section);
(glejte poglavje Druga zdravila in zdravilo
Cmax: ↑ 4.7-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Cmax: ↑ 4,7-krat zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Fosamprenavir/ ritonavir (700/100 mg
Fosamprenavir/ ritonavir (700/100 mg dvakrat na dan)
Caution should be exercised and reduced doses should be considered when Kaletra is co-administered with rosuvastatin (see section 4.4).
Potrebna je previdnost in med sočasno uporabo zdravila Kaletra in rosuvastatina pride v poštev uporaba manjših odmerkov (glejte poglavje 4.4).
Co-administration of Kaletra with rifampicin is not recommended.
Sočasna uporaba zdravila Kaletra in rifampicina ni priporočljiva.
Take care when dosing children.
Odmerjanje pri otrocih zahteva previdnost.
Concomitant Therapy: Efavirenz or nevirapine The following table contains dosing guidelines for Kaletra tablets based on BSA when used in combination with efavirenz or nevirapine in children.
Brez sočasnega zdravljenja z efavirenzom ali nevirapinom Naslednji tabeli vsebujeta smernice za odmerjanje zdravila Kaletra peroralna raztopina na osnovi telesne mase in indeksa telesne mase (ITM).
The pharmacokinetics of Kaletra 100/25 mg tablet twice-daily weight-band dosing without nevirapine have been studied in a total of 53 paediatric patients.
100/25 mg tablete dvakrat na dan z odmerjanjem glede na telesno maso brez nevirapina so raziskali pri skupaj 53 pediatričnih bolnikih.
Clinical monitoring of antiviral efficacy is recommended when these medicines are concomitantly administered with Kaletra.
Med uporabo teh zdravil z zdravilom Kaletra je priporočljiv kliničen nadzor protivirusne učinkovitosti.
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
Ob vključitvi je bila mediana (razpon) HIV-1 RNA 6,0 (4,7-7,2) log10 kopij/ml in mediana odstotka (razpon) T-celic CD4 41 (16-59).
Due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
Zaradi zavrtja CYP3A in P-gp z lopinavirjem/ritonavirjem.
Total amounts of alcohol and propylene glycol from all medicines that are to be given to infants should be taken into account in order to avoid toxicity from these excipients.
Da bi se izognili toksičnosti pomožnih snovi alkohola in propilenglikola, je treba upoštevati celotno količino alkohola in propilenglikola v vseh zdravilih, danih dojenčku.
Rivaroxaban (Ritonavir 600 mg twice daily)
Rivaroksaban (Ritonavir 600 mg dvakrat na dan)
Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section
Sočasna uporaba elbasvirja/grazoprevirja in zdravila Kaletra je kontraindicirana (glejte poglavje
At the recommended adult dose(s) of this medicine, the estimated blood alcohol concentration in your body is about 0.002 - 0.01 g/dL.
Pri priporočenih odmerkih tega zdravila za odrasle je ocenjena koncentracija alkohola v krvi približno
The twice-daily weight-band dosing without nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice-daily regimen without nevirapine.
Dvakrat dnevno odmerjenje glede na telesno maso brez nevirapina je v plazmi zagotovilo koncentracijo lopinavirja, podobno tisti pri odraslih bolnikih, ki so dobivali zdravilo po shemi 400/100 mg dvakrat na dan brez nevirapina.
Blood glucose disorders including diabetes mellitus, hypertriglyceridaemia, hypercholesterolemia, weight decreased, decreased appetite
Presnovne in prehranske motnje pogosti motnje glukoze v krvi vključno s sladkorno boleznijo, hipertrigliceridemija, hiperholesterolemija, znižanje telesne mase, zmanjšan apetit občasni zvišanje telesne mase, zvečan apetit
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.
Bolnike so randomizirali bodisi na 230 mg lopinavirja/57,5 mg ritonavirja na m2 ali 300 mg lopinavirja/75 mg ritonavirja na m2.
Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Zaradi pričakovane povečane izpostavljenosti rifabutinu je upravičen povečan nadzor z rifabutinom povezanih neželenih učinkov, vključno z nevtropenijo in uveitisom.
Co-administration of encorafenib with Kaletra may increase encorafenib exposure which may increase the risk of toxicity, including the risk of serious adverse events such as QT interval prolongation.
Sočasna uporaba enkorafeniba z zdravilom Kaletra lahko poveča izpostavljenost enkorafenibu, kar lahko poveča tveganje za toksičnost, vključno s tveganjem pojava resnih neželenih učinkov,
Recommended lopinavir/ritonavir dosing (mg) twice daily.
Priporočeni odmerki lopinavirja/ritonavirja (mg) dvakrat na dan.
Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia.
Pri bolnikih, ki so dobivali zdravilo Kaletra (vključno s tistimi, pri katerih se je razvila hipertrigliceridemija), so bili opisani primeri pankreatitisa.
Sustained virological response to Kaletra (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Dolgotrajni virološki odziv na zdravilo Kaletra (v kombinaciji z nukleozidnimi/nukleotidnimi zaviralci reverzne transkriptaze) so ugotovili tudi v majhni študiji II.
For children 2 weeks or older and weighing up to 15 kg
Za otroke, starejše od 2 tednov, ki tehtajo do15 kg.
Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from this agent (see section 4.5).
Zaradi tega večje tveganje za resne hematološke nepravilnosti ali druge resne neželene učinke tega zdravila (glejte poglavje 4.5).
The concomitant administration with alfuzosin is contraindicated (see section 4.5).
Sočasna uporaba z alfuzosinom je kontraindicirana (glejte poglavje 4.5).
Caution should be exercised in administering carbamazepine or phenobarbital with Kaletra.
Pri uporabi karbamazepina ali fenobarbitala z zdravilom Kaletra je potrebna previdnost.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Oral Solution - Bottle label
PODATKI NA PRIMARNI OVOJNINI Peroralna raztopina - nalepka na plastenki
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Oral solution - Carton containing 300 ml (5 bottles x 60 ml) oral solution
PODATKI NA ZUNANJI OVOJNINI Peroralna raztopina - škatla, ki vsebuje 300 ml (5 plastenk po 60 ml) peroralne raztopine
No dose adjustment necessary.
Prilagoditev odmerka ni potrebna.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
je treba razmisliti o prekinitvi ali opustitvi zdravljenja.
AUC: ↑ 3-fold Cmax: ↑ 1.8-fold
AUC: ↑ 3-krat Cmax: ↑ 1,8-krat
Interactions with medicinal products
PROMET Z ZDRAVILOM
Increased plasma concentrations of avanafil (see sections 4.4 and 4.5).
Zvišane plazemske koncentracije avanafila (glejte poglavji 4.4 in 4.5).
Caution must also be exercised and reduced doses should be considered if Kaletra is used concurrently with rosuvastatin.
Previdnost je potrebna tudi pri hkratni uporabi zdravila Kaletra z rosuvastatinom; razmisliti je treba o zmanjšanju odmerkov.
This may cause nausea, vomiting, colic, severe purgation at high doses.
Ta lahko v velikih odmerkih povzroči občutek siljenja na bruhanje, bruhanje, črevesne krče in močan odvajalen učinek.
300 ml (5 bottles x 60 ml) oral solution with five 5 ml oral dosing syringes.
300 ml (5 plastenk po 60 ml) peroralne raztopine s petimi 5 ml brizgami za peroralno dajanje
• anti-gout medicines (e.g. colchicine).
- zdravila za zdravljenje protina (npr. kolhicin).
CYP3A4 inhibition likely due to lopinavir/ritonavir.
Zavrtje CYP3A4 je verjetno zaradi lopinavirja/ritonavirja.
A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Cmax: ↔ Bolj izrazit učinek na koncentracijo bedakilina v plazmi se lahko opazi med podaljšano sočasno uporabo z lopinavirjem/ritonavirjem.
Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.
Ena filmsko obložena tableta vsebuje 100 mg lopinavirja, koformuliranega s 25 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
Protocol defined non-inferiority of once-daily dosing compared with twice-daily dosing was demonstrated if the lower bound of the 95% confidence interval for the difference in proportion of subjects responding (once daily minus twice daily) excluded -12% at Week 48.
Pri 95% spodnji meji zaupanja za razliko pri deležu bolnikov, ki so se odzvali (enkrat dnevno minus dvakrat dnevno), izključujoč -12 % v 48. tednu, je bilo enkrat dnevno odmerjanje v primerjavi z dvakrat dnevnim odmerjanjem neinferiorno kot definirano po protokolu.
Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Večje koncentracije lovastatina in simvastatina v plazmi; zaradi tega večje tveganje za miopatijo, vključno z rabdomiolizo (glejte poglavje 4.5).
Increased creatine phosphokinase (CPK), myalgia, myositis, and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
Med uporabo zaviralcev proteaz so, zlasti v kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze, poročali o zvišanju kreatin fosfokinaze (CPK), mialgiji, miozitisu in, redko, rabdomiolizi.
The combination of Kaletra with atorvastatin is not recommended.
Uporaba zdravila Kaletra v kombinaciji z atorvastatinom ni priporočljiva.
Lopinavir/ritonavir medicinal product level decreased
Znižanje koncentracije zdravila z lopinavirjem/ritonavirjem
• Kaletra contains the active substances lopinavir and ritonavir.
Zdravilo Kaletra vsebuje zdravilni učinkovini lopinavir in ritonavir.
Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Koloidni brezvodni silicijev dioksid, kopovidon, natrijev stearilfumarat, sorbitan lavrat.
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Ena filmsko obložena tableta vsebuje 200 mg lopinavirja, koformuliranega s 50 mg ritonavirja kot farmakokinetičnim stopnjevalcem.
Amiodarone, Dronedarone Amiodarone, Dronedarone: Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Amiodaron, dronedaron Amiodaron, dronedaron: zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se koncentracija lahko zviša.
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro.
Zdravilo Kaletra vsebuje lopinavir in ritonavir, ki in vitro oba zavirata izoobliko CYP3A P450.
Fusidic Acid
Fusidna kislina