natgillin/translations-raw huggingface dataset:
Lopinavir/ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes. 
Mutagenost lopinavirja/ritonavirja so preizkusili s skupino preskusov in vitro in in vivo, med drugim z Amesovim preskusom bakterijske reverzne mutacije, mišjim limfomskim preskusom, mikronukleusnim testom pri miših in preskusi kromosomskih aberacij v človeških limfocitih; nobeden ni pokazal, da bi bila kombinacija mutagena ali klastogena.
The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5). 
Sočasna uporaba fusidne kisline je kontraindicirana pri dermatoloških okužbah (glejte poglavje 4.5).
− If you notice you miss a dose by more than 12 hours after your normal dosing time, do not take the missed dose. 
Če opazite, da ste pozabili vzeti odmerek zdravila več kot 12 ur po predvidenem času jemanja, ne vzemite izpuščenega odmerka.
Co-administration of Kaletra with tadalafil is not recommended. 
Kaletra s tadalafilom ni priporočljiva.
The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/abnormal stool. 
Med neželenimi kliničnimi znaki pri psih so bili slinjenje, emeza in driska oz. nenormalno blato.
Lipid-modifying agents HMG Co-A Reductase Inhibitors 
Zaviralci reduktaze HMG Co-A
Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ritonavir. 
Med zdravljenjem z lopinavirjem/ritonavirjem so redko poročali o atrioventrikularnem bloku 2. ali 3. stopnje pri bolnikih, ki so imeli osnovno organsko bolezen in že obstoječe nepravilnosti prevodnega sistema, in bolnikih, zdravljenih z zdravili, ki podaljšajo interval PR (npr. verapamil ali atazanavir).
Includes: alcohol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium). 
Vsebuje: alkohol, visokofruktozni koruzni sirup, propilenglikol, glicerol, makrogolglicerol 40 hidrogenirano ricinusovo olje, kalij (kot kalijev acesulfamat).
Hypromellose, titanium dioxide, macrogols type 400 (polyethylene glycol 400), hydroxypropyl cellulose, talc, colloidal anhydrous silica, macrogols type 3350 (polyethylene glycol 3350), yellow ferric oxide E172, polysorbate 80. 
Hipromeloza, titanov dioksid, makrogol 400 (polietilenglikol 400), hidroksipropilceluloza, smukec, brezvodni koloidni silicijev dioksid, makrogol 3350 (polietilenglikol 3350), rumeni železov oksid E172, polisorbat 80.
− If you notice you miss a dose by more than 6 hours after your normal dosing time, do not take the missed dose. 
Če opazite, da ste pozabili vzeti odmerek zdravila več kot 6 ur po predvidenem času jemanja, ne vzemite izpuščenega odmerka.
More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC). 
Priporočeno je pogostejše spremljanje z elektrokardiogrami in spremljanje koncentracij transaminaz (glejte poglavje 4.5 in se obrnite na informacije v povzetku glavnih značilnosti zdravila za bedakilin).
Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended. 
Glede na trenutne terapevtske smernice dvotirno zdravljenje z zaviralci proteaz praviloma ni priporočljivo.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Bedaquiline: AUC: ↑ 22% 
Bedakilin: AUC: ↑ 22 %
If the benefit outweighs the risk, co-administration of bedaquiline with Kaletra must be done with caution. 
Če je korist večja od tveganja, je pri sočasni uporabi bedakilina z zdravilom Kaletra potrebna previdnost.
Finger grip 
Držalo za prste
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC). 
Priporočeno je pogostejše spremljanje z elektrokardiogrami in spremljanje koncentracij transaminaz (glejte poglavje 4.4 in se obrnite na informacije v povzetku glavnih značilnosti zdravila za bedakilin).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease. 
Nekateri od številnih dejavnikov tveganja za pojav te bolezni so lahko trajanje kombiniranega protiretrovirusnega zdravljenja, uporaba kortikosteroidov, uživanje alkohola, huda imunosupresija (zmanjšanje aktivnosti imunskega odziva) in višji indeks telesne mase.
Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment. 
Ledvični očistek lopinavirja in ritonavirja je zanemarljiv, zato pri bolnikih z okvaro ledvic ni pričakovati zvišane koncentracije v plazmi.
Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4, such as budesonide and triamcinolone, 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). 
CYP3A4, kot sta budezonid in triamcinolon, se ne priporoča, razen če možna korist zdravljenja preseže tveganje za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4.5).
No dose adjustment necessary 
Prilagoditev odmerka ni potrebna
Adultc a. Kaletra oral solution 230/57.5 mg/m2 twice daily regimen without nevirapine b. Kaletra oral solution 300/75 mg/m2 twice daily regimen with nevirapine c. Kaletra film-coated tablets 400/100 mg twice daily at steady state 
Odraslic a. Zdravilo Kaletra peroralna raztopina 230/57,5 mg/m2 shema dvakrat na dan brez nevirapina b. Zdravilo Kaletra peroralna raztopina 300/75 mg/m2 shema dvakrat na dan z nevirapinom c. Zdravilo Kaletra filmsko obložene tablete 400/100 mg dvakrat na dan v stanju dinamičnega ravnovesja
• allergic reactions including hives and inflammation in the mouth; 
- vnetje jeter vključno s povišanimi jetrnimi encimi; - alergijske reakcije vključno s koprivnico in vnetjem v ustih;
How much Kaletra should be taken and when? 
Koliko zdravila Kaletra naj uporabim in kdaj Uporaba pri odraslih
Talk to your doctor or pharmacist before taking Kaletra. 
Pred začetkom jemanja zdravila Kaletra se posvetujte z zdravnikom ali farmacevtom.
Kaletra is contraindicated in patients with severe liver impairment (see section 4.3). 
Zdravilo Kaletra je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
After each dose of Kaletra separate the plunger and the syringe. 
Po vsakem odmerjanju zdravila Kaletra potegnite bat iz brizge.
M98-957 is a randomised, open-label study evaluating Kaletra treatment at two dose levels (400/100 mg and 533/133 mg, both twice daily) plus efavirenz (600 mg once daily) and nucleoside reverse transcriptase inhibitors in 57 multiple protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients. 
M98-957 je randomizirana, odprta študija za oceno zdravljenja z zdravilom Kaletra v dveh različnih odmerkih (400/100 mg in 533/133 mg, oboje dvakrat na dan) hkrati z efavirenzem (600 mg enkrat na dan) ter nukleozidnimi zaviralci reverzne transkriptaze pri 57 bolnikih, izkušenih z več zaviralci proteaz in naivnih za nenukleozidne zaviralce reverznih transkriptaz.
Concomitant administration of Kaletra with fusidic acid is contraindicated in dermatological indications due to the increased risk of adverse events related to fusidic acid, notably rhabdomyolysis (see section 4.3). 
Sočasna uporaba zdravila Kaletra s fusidno kislino je kontraindicirana pri dermatoloških indikacijah, ker obstaja večje tveganje za neželene učinke, povezane s fusidno kislino, zlasti za rabdomiolizo (glejte poglavje 4.3).
Kaletra 100 mg/25 mg film-coated tablets are supplied in plastic bottles containing 60 tablets. 
Filmsko obložene tablete zdravila Kaletra z jakostjo 100mg/20mg so na voljo v plastenkah, ki vsebujejo 60 tablet.
PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg film-coated tablets) - without blue box 
Vmesna škatla v multipakiranju s 120 (3 pakiranja s 40) 200mg/50mg filmsko obloženimi tabletami - brez modrega okenca
• You must not take Kaletra with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also Do not take Kaletra section above). 
- Zdravila Kaletra ne smete jemati s sildenafilom, ki se uporablja za zdravljenje pljučne arterijske hipertenzije (visok krvni tlak v pljučni arteriji) (glejte poglavje zgoraj Ne jemljite zdravila
Lopinavir/ritonavir was administered twice daily at 16/4 mg/kg for subjects 2 months to < 6 months, 12/3 mg/kg for subjects ≥ 6 months and < 15 kg, 10/2.5 mg/kg for subjects ≥ 6 months and ≥ 15 kg to < 40 kg, or 400/100 mg for subjects ≥ 40 kg. 
Preiskovanci so prejemali kombinacijo lopinavir/ritonavir dvakrat na dan v odmerkih 16/4 mg/kg pri starosti od 2 mesecev do < 6 mesecev, 12/3 mg/kg pri starosti ≥ 6 mesecev in < 15 kg, 10/2,5 mg/kg pri starosti ≥ 6 mesecev in ≥ 15 kg do < 40 kg ali 400/100 mg pri preiskovancih ≥ 40 kg. Shema z nevirapinom je vključevala 160-200 mg/m2 enkrat na dan 14 dni, nato 160-200 mg/m2 vsakih 12 ur.
Lipid lowering agents Lovastatin and Simvastatin 
Zdravila za zniževanje lipidov Lovastatin in simvastatin
Co-administration of ibrutinib and Kaletra should be avoided. 
Sočasni uporabi ibrutiniba in zdravila Kaletra se je treba izogniti.
In an open-label pharmacokinetic study, 12 HIV-infected pregnant women who were less than 20 weeks of gestation and on combination antiretroviral therapy initially received lopinavir/ritonavir 400 mg/100 mg (two 200/50 mg tablets) twice daily up to a gestational age of 30 weeks. 
V odprti farmakokinetični študiji je 12 nosečnic, okuženih s HIV, z gestacijsko dobo manj kot 20 tednov in na kombinirani protivirusni terapiji, na začetku dobivalo lopinavir/ritonavir 400 mg/100 mg
Severe hepatic insufficiency. 
Huda insuficienca jeter.
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. 
Študija M97-765 je randomizirano, dvojno slepo preskušanje za oceno zdravila Kaletra v dveh različnih odmerkih (400/100 mg in 400/200 mg, oboje dvakrat na dan) hkrati z nevirapinom (200 mg dvakrat na dan) ter dvema nukleozidnima zaviralcema reverzne transkriptaze pri 70 bolnikih, izkušenih z enim zaviralcem proteaz in naivnih za nenukleozidne zaviralce reverznih transkriptaz.
Cmax: ↑ 6-fold 
Cmax: ↑ 6-krat
Buprenorphine, 16 mg QD 
Buprenorfin, 16 mg enkrat na dan
AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold 
AUC: ↑ 11,86-krat Cmax: ↑ 6,31-krat
If this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. 
Če se sočasni uporabi ni možno izogniti, za priporočila glede prilagoditve odmerka glejte povzetek glavnih značilnosti zdravila za abemaciklib.
Increased plasma concentrations of lomitapide (see section 4.5). 
Povečane koncentracije lomitapida v plazmi (glejte poglavje 4.5).
(Ritonavir 200 mg twice daily) 
(Ritonavir 200 mg dvakrat na dan)
Increased plasma concentrations of pimozide. 
Večja koncentracija pimozida v plazmi.
Dosage recommendation for paediatric patients older than 6 months to less than 18 years Without Concomitant Efavirenz or Nevirapine 
Priporočila za odmerjanje pri pediatričnih bolnikih, starejših od 6 mesecev in mlajših od 18 let
Uncommon Visual impairment 
Očesne bolezni občasni motnje vida
Monitor for ADRs related to ceritinib. 
Spremljajte neželene učinke, ki so povezani s ceritinibom.
AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold 
AUC: ↑ 2,71-krat Cmax: ↑ 1,87-krat C24: ↑ 3,58-krat
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg Tablets - Carton of multipack containing 360 (3 bottles of 120) film-coated tablets - including blue box 
200 mg/50 mg tablete - škatla multipakiranja, ki vsebuje 360 ( 3 plastenke po 120) filmsko obloženih tablet - vključno z modrim okencem
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. 
Odprite za otroke varno zaporko tako, da jo z dlanjo pritisnete navzdol in zavrtite v smeri, nasprotni urinemu kazalcu oz. v smeri puščice, ki je na vrhu zaporke.
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Kaletra is required. 
Pri bolnikih z normalnim delovanjem ledvic ali jeter, ki potrebujejo zdravljenje z zdravilom Kaletra, je priporočljivo zmanjšati odmerek kolhicina ali prekiniti zdravljenje s kolhicinom.
(relative to indinavir 800 mg TID alone) 
(v primerjavi z 800 mg samega indinavirja trikrat na dan)
AUC: ↑ 6.10-fold Cmax: ↑ 4.76-fold Ctrough: ↑ 12.33-fold 
AUC: ↑ 6,10-krat Cmax: ↑ 4,76-krat Ctrough: ↑ 12,33-krat
Tipranavir/ritonavir (500/100 mg BID) 
Tipranavir/ritonavir (500/100 mg dvakrat na dan)
Alpha1 adrenoreceptor antagonist Alfuzosin 
Zaviralec adrenergičnih receptorjev alfa1
Immune Reconstitution Inflammatory Syndrome 
Vnetni sindrom imunske rekonstitucije
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