natgillin/translations-raw huggingface dataset:
Through Week 48, genotypic resistance testing results were available from 75 patients in the QD group and 75 patients in the BID group who had incomplete virologic response.
V 48. tednu so bili na voljo rezultati testiranja genotipske odpornosti za 75 bolnikov v skupini, ki je prejemala zdravilo 1 x dnevno, in za 75 bolnikov v skupini, ki je prejemala zdravilo 2 x dnevno in ki je imela nepopoln virološki odgovor.
Cmax Cpredose μg /mL
Cmax Cpred odmerkom μg /ml
It should not be given when intestinal obstruction is present.
Ne sme se uporabljati v primeru obstrukcije črevesa.
Ergot alkaloids
Alkaloidi ergot
The dose of Kaletra may need adjusting.
Potrebna je lahko prilagoditev odmerka zdravila Kaletra.
You must not take Kaletra with colchicine if you have kidney and/or liver problems (see also ‘Do not take Kaletra' above);
Zdravila Kaletra ne smete jemati skupaj s kolhicinom, če imate težave z ledvicami in/ali jetri (glejte tudi ‘Ne jemljite zdravila Kaletra'
Mean increase from baseline in CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures
Srednje povečanje števila T-celic CD4 od začetka (celic/mm3) *analiza z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh
• inflammation of the first section of the small intestine just after the stomach, wound or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
- vnetje prvega dela tankega črevesa takoj za želodcem, rana ali razjeda v prebavilih, krvavitev iz prebavil ali rektuma;
− 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.
Če opazite, da ste pozabili vzeti odmerek zdravila v 12 urah od predvidenega časa jemanja, vzemite izpuščeni odmerek čim prej in nato nadaljujte z odmerjanjem kot običajno, kakor vam je predpisal zdravnik.
Analgesics Fentanyl
Analgetiki Fentanil
− If you notice you miss a dose within 6 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.
Če opazite, da ste pozabili vzeti odmerek zdravila v 6 urah od predvidenega časa jemanja, vzemite izpuščeni odmerek čim prej in nato nadaljujte z odmerjanjem kot običajno, kakor vam je predpisal zdravnik.
KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
(celic/mm3) KONCERT/PENTA 18 je prospektivna, multicentrična, randomizirana, odprta študija, ki je ocenila farmakokinetični profil, učinkovitost in varnost odmerjanja dvakrat na dan napram enkrat na dan za kombinacijo lopinavir/ritonavir 100 mg/25 mg tablete; odmerjane glede na maso kot del kombiniranega protiretrovirusnega zdravljenja (cART - combination antiretroviral therapy) pri virološko suprimiranih otrocih, okuženih s HIV-1 (n=173).
Administration of Kaletra with a high fat meal (872 kcal, 55.8% from fat) increased lopinavir AUC and Cmax by 96% and 43%, respectively, for soft capsules, and 130% and 56%, respectively, for oral solution.
Uporaba zdravila Kaletra z zelo mastnim obrokom (872 kcal, 55,8 % iz maščob) je zvečala AUC oz. Cmax mehkih kapsul za 96 % oz. 43 %, peroralne raztopine pa za 130 % oz. 56 %.
Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V in L90M.
The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Vključena populacija je bila zmerno izkušena z zaviralci proteaz: več kot polovica bolnikov ni še nikoli prej dobivalo zaviralce proteaz in približno 80
Lopinavir AUC over a 12 hour dosing interval averaged 113.2 ± 60.5 µg•h/ml.
AUC lopinavirja med 12 urnim odmernim intervalom je bila v povprečju 113,2 ± 60,5 µg•h/ml.
Amprenavir concentrations are significantly reduced.
Fosamprenavir: koncentracija amprenavirja se bistveno zniža.
Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5).
Povečano tveganje za sindrom tumorske lize pri začetnem odmerjanju in med fazo povečevanja odmerka (glejte poglavje 4.5).
PDE5 inhibitors
Zaviralci PDE5
Reduced serum thyroxin led to an increased release of TSH with resultant follicular cell hypertrophy in the thyroid glands of rats.
Znižanje tiroksina v serumu je pri podganah povzročilo zvečano sproščanje TSH in posledično hipertrofijo folikelskih celic v ščitnici.
Cushing's syndrome has 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 (see section 4.4 and 4.5).
Pri bolnikih, ki so prejemali ritonavir in inhalacijsko ali intranazalno uporabljen flutikazon propionat, so poročali o Cushingovem sindromu; ta se lahko pojavi tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo preko poti P450 3A, npr. budenozid (glejte poglavji 4.4 in 4.5).
The most common adverse reactions related to Kaletra therapy during clinical trials were diarrhoea, nausea, vomiting, hypertriglyceridaemia and hypercholesterolemia.
Najpogostejši neželeni učinki, povezani z zdravljenjem z zdravilom Kaletra, v kliničnih študijah, so bili driska, slabost, bruhanje, hipertrigliceridemija in hiperholesterolemija.
Patients with prior antiretroviral therapy
Bolniki s predhodnim protiretrovirusnim zdravljenjem
Herbal preparations containing St John's wort must not be combined with lopinavir and ritonavir.
Zeliščnih pripravkov s šentjanževko se ne sme kombinirati z lopinavirjem in ritonavirjem.
Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely.
Ne vozite in ne upravljajte s stroji, če se vam pojavi katerikoli neželeni učinek (npr.
Children less than 2 years of age
Otroci, mlajši od 14 dni in nedonošenčki
− Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
- zdravniku povejte, če vam je slabo, bruhate ali vas boli trebuh, ker bi to lahko kazalo na pankreatitis (vnetje trebušne slinavke);
Multipack: 120 (3 packs of 40) film-coated tablets 120 film-coated tablets
Multipakiranje: 120 (3 pakiranja s 40) filmsko obloženih tablet 120 filmsko obloženih tablet
These increases of plasma concentrations of co-administered medicinal products could increase or prolong their therapeutic effect and adverse events (see sections 4.3 and
Zvečana koncentracija sočasno uporabljenih zdravil v plazmi lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke (glejte poglavji 4.3 in 4.5).
After 48 weeks of treatment with Kaletra, efavirenz and nucleoside reverse transcriptase inhibitors, plasma HIV RNA ≤ 400 copies/ml was observed in 93% (25/27), 73% (11/15), and 25% (2/8) of patients with < 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
Po 48 tednih zdravljenja z zdravilom Kaletra, efavirenzem in nukleozidnimi zaviralci reverzne transkriptaze so HIV RNA v plazmi ≤ 400 kopij/ml ugotovili pri 93 % (25/27), 73% (11/15), in 25 % (2/8) bolnikov z < 10
For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions).
Za bolnike, ki so zaključili fazo povečevanja odmerka in prejemajo stalen dnevni odmerek venetoklaksa, zmanjšajte odmerek venetoklaksa za najmanj 75 %,
Concomitant use of Kaletra with lomitapide is contraindicated (see prescribing information for lomitapide) (see section 4.3).
Sočasna uporaba zdravila Kaletra z lomitapidom je kontraindicirana (glejte informacije o predpisovanju za lomitapid) (glejte poglavje 4.3).
Lopinavir is extensively metabolised by the hepatic cytochrome P450 system, almost exclusively by isozyme CYP3A.
Lopinavir se izdatno presnavlja s sistemom jetrnega citokroma P450, skoraj izključno z izoencimom CYP3A.
A more pronounced effect on DM-6705 exposure may be observed during prolonged coadministration with lopinavir/ritonavir.
AUC: ↑ 30 % Bolj izrazit učinek na izpostavljenost DM-6705 se lahko opazi med podaljšano sočasno uporabo z lopinavirjem/ritonavirjem.
• Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
- Zdravnik vam je predpisal zdravilo Kaletra za obvladovanje okužbe z virusom humane imunopomanjkljivosti (HIV).
If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring.
Če je uporaba atorvastatina res potrebna, je treba uporabiti najmanjši možni odmerek atorvastatina in potrebno je natančno varnostno spremljanje
At entry, median age was 0.7 years, median CD4 T-cell count was 1147 cells/mm3, median CD4 T-cell was 19%, and median HIV-1 RNA was > 750,000 copies/ml.
Ob vključitvi je bila mediana starosti 0,7 leta, mediana števila T-celic CD4 1147 celic/mm3, mediana deleža T-celic CD4 19 % in mediana HIV-1 RNA > 750,000 kopij/ml.
The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 µg/ml.
Povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja pred jutranjim odmerkom je bila 8,1 ± 5,7 µg/ml.
Read the list of medicines below under ‘Other medicines and Kaletra' for information on certain other medicines which require special care.
Za informacije o drugih zdravilih, ki zahtevajo posebno pozornost, preberite seznam zdravil spodaj v poglavju “Druga zdravila in zdravilo Kaletra”.
Adult patients who have previously taken other antiviral medicines can take Kaletra tablets once daily as an 800 mg/200 mg dose if their doctor decides it is appropriate.
Odrasli bolniki, ki so predhodno dobivali druga protiretrovirusna zdravila, lahko tablete zdravila Kaletra jemljejo enkrat na dan v odmerku 800 mg/200 mg, če njihov zdravnik presodi, da je to primerno.
Concomitant Therapy: Efavirenz or Nevirapine
Sočasna zdravila: efavirenz ali nevirapin
Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects.
Ugotovljeno je, da kombinacija lopinavir/ritonavir nekaterim zdravim odraslim osebam zmerno in asimptomatsko podaljša interval PR.
In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2).
Pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaro so opazili za približno 30% večjo izpostavljenost lopinavirju, vendar ni pričakovati, da bi to bilo klinično pomembno (glejte poglavje
• Diabetes as increased blood sugars has been reported in patients receiving Kaletra.
- sladkorno bolezen, ker so pri bolnikih, ki so jemali zdravilo Kaletra, poročali o zvišanem krvnem sladkorju.
Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, Velika Britanija AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska AbbVie Deutschland GmbH & Co.
Through Week 96, genotypic resistance testing results were available from 25 patients in the QD group and 26 patients in the BID group who had incomplete virologic response.
V 96.tednu so bili rezultati testiranja genotipske odpornosti na voljo za 25 bolnikov v skupini, ki je jemala zdravilo 1 x dnevno in 26 bolnikov v skupini, ki je jemala zdravila 2 x dnevno in ki je imela nepopoln virološki odgovor.
Sixty-one patients completed the study (35 patients received the recommended 400/100 mg twice daily dose throughout the study).
Študijo je dokončalo 61 bolnikov (35 bolnikov je ves čas študije dobivalo priporočeni odmerek 400/100 mg dvakrat na dan).
Patients were randomised in a 1:1 ratio to receive either Kaletra 800/200 mg once daily (n = 333) or Kaletra 400/100 mg twice daily (n = 331).
Bolniki so bili v razmerju 1:1 randomizirani na zdravljenje z zdravilom Kaletra 800/200 mg enkrat na dan (n = 333) ali zdravilo Kaletra 400/100 mg dvakrat na dan (n = 331).
Antianginal Ranolazine
Antianginozna zdravila Ranolazin
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
• If the dose is between 2 ml and 5 ml - use the 5 ml oral dosing syringe to prepare a dose.
- Če je odmerek med 2 ml in 5 ml, za pripravo odmerka uporabite 5 ml brizgo za peroralno dajanje.
Concomitant medicinal product levels increased Alpha1-adrenoreceptor antagonist
Zvišanje koncentracije sočasno uporabljenih zdravil Zaviralec adrenergičnih receptorjev alfa1
Due to P-gp and/or CYP3A4 inhibition by ritonavir.
Zaradi zavrtja P-gp in/ali CYP3A4 z ritonavirjem.
Increased risk of alanine transaminase (ALT) elevations (see section 4.5).
Povečano tveganje za povišanje alanin transaminaze (ALT) (glejte poglavje 4.5).
Administration of a single 400/100 mg dose of Kaletra tablets under fed conditions (high fat, 872 kcal, 56% from fat) compared to fasted state was associated with no significant changes in Cmax and AUCinf.
Uporabe posamičnega odmerka 400/100 mg tablet zdravila Kaletra na poln želodec (z mastnim obrokom, 872 kcal, 56 % iz maščob) v primerjavi z uporabo na tešče ni spremljala pomembna sprememba Cmax in AUCinf.
• Kaletra is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
- Zdravilo Kaletra se uporablja pri otrocih, starih 2 leti ali več, mladostnikih in odraslih, okuženih s HIV, virusom, ki povzroča AIDS.
Ritonavir is a potent CYP3A inhibitor which inhibits the metabolism of lopinavir and therefore, increases plasma levels of lopinavir.
Ritonavir je močan zaviralec CYP3A, zavira presnovo lopinavirja in tako zvečuje koncentracijo lopinavirja v plazmi.
In the QD group, no patient demonstrated lopinavir resistance, and in the BID group, 1 patient who had significant protease inhibitor resistance at baseline demonstrated additional lopinavir resistance on study.
V skupini, ki je jemala zdravilo 1 x dnevno, ni noben bolnik pokazal odpornosti proti lopinavirju, v skupini, ki je jemala zdravilo 2 x dnevno, pa je 1 bolnik, ki je imel v začetku pomembno odpornost proti zaviralcem proteaze, pokazal dodatno odpornost proti lopinavirju med študijo.
After a 400/100 mg 14C-lopinavir/ritonavir dose, approximately 10.4 ± 2.3% and 82.6 ± 2.5% of an administered dose of 14C-lopinavir can be accounted for in urine and faeces, respectively.
Po odmerku 400/100 mg 14C-lopinavirja/ritonavirja se v urinu izloči približno 10,4 ± 2,3 % uporabljenega odmerka 14C-lopinavirja in v blatu 82,6 ± 2,5 %.
Kaletra must not be administered once daily in combination with carbamazepine and phenobarbital.
Zdravila Kaletra se ne sme uporabljati enkrat na dan v kombinaciji s karbamazepinom in fenobarbitalom.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
• lovastatin, simvastatin (used to lower blood cholesterol);
- lovastatin, simvastatin (uporabljata se za zniževanje ravni holesterola v krvi); - lomitapid (uporablja se za zniževanje ravni holesterola v krvi);
Anti-infectives Fusidic acid
Antiinfektivi Fusidna kislina
When co-administered with carbamazepine or phenobarbital, an increase of Kaletra dosage may be envisaged.
Med sočasno uporabo s karbamazepinom ali fenobarbitalom je treba predvideti povečanje odmerka zdravila
Concomitant administration of Kaletra and ergot alkaloids are contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3).
Sočasna uporaba zdravila Kaletra in ergot alkaloidov je kontraindicirana, saj lahko vodi v akutno ergot toksičnost, vključno z vazospazmom in ishemijo (glejte poglavje 4.3).
Tenofovir disoproxil fumarate (DF), 300 mg QD
Dizoproksiltenofovirijev fumarat (DF), 300 mg enkrat na dan
Contents of the pack and other information
Shranjevanje zdravila Kaletra Vsebina pakiranja in dodatne informacije
• No dose adjustment is required for lopinavir/ritonavir during pregnancy and postpartum.
• Med nosečnostjo in po porodu ni potrebna prilagoditev odmerka lopinavirja/ritonavirja.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
KG, Knollstrasse, 67061 Ludwigshafen, Nemčija
Put the syringe back together and draw up and expel tap water a few times to rinse.
Brizgo nato spet sestavite ter vanjo oz. iz nje nekajkrat potegnite oz. iztisnite navadno vodo, da jo boste splaknili.
Weight (kg)
Telesna masa (kg)
Read the list of medicines above ‘Do not take Kaletra with any of the following medicines' for information on medicines that you must not take with Kaletra.
Za informacije o zdravilih, ki jih ne smete jemati skupaj z zdravilom Kaletra, preberite seznam zdravil zgoraj v poglavju “Ne jemljite zdravila Kaletra, če trenutno jemljete katero od naslednjih zdravil”.
• increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood, high blood pressure;
- otekanje ali vnetje želodca, črevesja in debelega črevesa; - povišan nivo holesterola v krvi, povišan nivo trigliceridov (oblika maščobe) v krvi, visok krvni tlak;
Observed data
Zabeleženi podatki
• eye disorder, abnormal vision;
- bolezni oči, nenormalen vid;
Using the 2 ml oral dosing syringe for doses up to 2 ml
Uporaba 2 ml brizge za peroralno dajanje za odmerke do 2 ml
Administration of a single 400/100 mg dose of Kaletra soft capsules with a moderate fat meal (500 - 682 kcal, 22.7 -25.1% from fat) was associated with a mean increase of 48% and 23% in lopinavir AUC and Cmax, respectively, relative to fasting.
Uporaba posameznega odmerka 400/100 mg mehkih kapsul zdravila Kaletra z zmerno mastnim obrokom (500-682 kcal, 22,7 % do 25,1 % iz maščob) je bila povezana s povprečnim zvečanjem AUC lopinavirja za 48 % in Cmax za 23 % v primerjavi z uporabo na tešče.
To date, there is limited human experience of acute overdose with Kaletra.
Izkušnje z akutnim prevelikim odmerjanjem zdravila Kaletra pri ljudeh so doslej omejene.
Let the syringe dry completely before you use that syringe for dosing.
Preden to isto brizgo znova uporabite za odmerjanje, jo morate pustiti, da se popolnoma posuši.
Blister multipacks containing 120 tablets (1 pack of 120 tablets or 3 packs each containing 40 tablets) are also available.
Na voljo so tudi multipakiranja s 120 tabletami v pretisnih omotih (1 pakiranje s 120 tabletami ali 3 pakiranja, od katerih vsako vsebuje 40 tablet).
Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Velika Britanija AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska AbbVie Deutschland GmbH & Co.
HCV protease inhibitors Simeprevir 200 mg daily (ritonavir 100 mg BID)
Zaviralci proteaze HCV Simeprevir 200 mg/dan (ritonavir 100 mg dvakrat na dan)
Kaletra is not a cure for HIV infection or AIDS.
Zdravilo Kaletra ne ozdravi okužbe s HIV ali aidsa.
Beta2-adrenoceptor agonist (long acting) Salmeterol
Agonisti adrenergičnih receptorjev beta2 (dolgodelujoči)
Increased plasma concentrations of paritaprevir; thereby, increasing the risk of alanine transaminase (ALT) elevations (see section 4.5).
Povečana koncentracija paritaprevirja v plazmi; zato je povečano tveganje za povišanja alanin transaminaze (ALT) (glejte poglavje 4.5).
Blisters packs - polyvinyl chloride (PVC) blisters with fluoropolymer foil backing Two pack sizes are available: - carton containing 120 film-coated tablets - multipack containing 120 (3 cartons of 40) film-coated tablets
Pakiranja pretisnih omotov - pretisni omoti iz polivinilklorida (PVC) s folijo iz fluoropolimera Na trgu sta dve pakiranji: - škatla, ki vsebuje 120 filmsko obloženih tablet - multipakiranje, ki vsebuje 120 (3 škatle po 40) filmsko obloženih tablet
Two pack sizes are available for Kaletra oral solution: - 120 ml (2 bottles x 60 ml) with 2 x 2 ml syringes with 0.1 ml graduations
Na voljo sta dve velikosti pakiranja zdravila Kaletra peroralna raztopina: - 120 ml (2 plastenki po 60 ml) z dvema 2 ml brizgama z 0,1 ml oznakami.
Push the plunger all of the way into the barrel.
Bat potisnite do konca cevi.
Serum concentrations of sofosbuvir, velpatasvir and voxilaprevir may be increased due to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir.
Serumske koncentracije sofosbuvirja, velpatasvirja in voksilaprevirja se lahko zvišajo zaradi zavrtja P-glikoproteina, BCRP in OATP1B1/3 z lopinavirjem/ritonavirjem.
More frequent therapeutic concentration monitoring is recommended until plasma levels of these products have been stabilised.
Dokler se koncentracija teh zdravil v plazmi ne stabilizira, je priporočljivo pogosteje kontrolirati terapevtsko koncentracijo.
Kaletra film-coated tablets are supplied in packs containing 120 tablets (1 plastic bottle of 120 tablets) and multipacks comprising 3 plastic bottles each containing 120 tablets (360 tablets).
Zdravilo Kaletra filmsko obložene tablete so na voljo v pakiranju, ki vsebuje 120 tablet (1 plastenka s 120 tabletami) in multipakiranju, ki vsebuje 3 plastenke, od katerih vsaka vsebuje 120 tablet (360 tablet).
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Kombinacija lahko poveča tveganje za srčno-žilne neželene učinke, povezane s salmeterolom, vključno s podaljšanjem QT,
• Kaletra is prescribed for use in combination with other antiviral medicines.
Zdravilo Kaletra se uporablja v kombinaciji z drugimi protivirusnimi zdravili.
(25/150/100 mg QD + 400 mg BID)
(25/150/100 mg enkrat na dan + 400 mg 2x dnevno)
− medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
zdravila za urejanje srčnega ritma (npr. bepridil, sistemski lidokain, kinidin);
Bottle containing 60 film-coated tablets.
Plastenka vsebuje 60 filmsko obloženih tablet.
Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
občasni hepatična steatoza, hepatomegalija, holangitis, hiperbilirubinemija neznana pogostnost zlatenica
Modest prolongation of the PR interval was also noted in subjects receiving lopinavir/ritonavir in the same study on Day 3.
Med preiskovanci, ki so dobivali lopinavir/ritonavir, so v isti študiji 3. dan ugotovili zmerno podaljšanje intervala PR.
Therefore, Kaletra tablets may be taken with or without food.
Tablete zdravila Kaletra lahko torej bolnik vzame s hrano ali brez nje.
• 300 ml (5 bottles x 60 ml).
- 300 ml (5 plastenk po 60 ml).
The following table contains dosing guidelines for Kaletra 100/25 mg tablets based on body weight and BSA.
Naslednja tabela prikazuje smernice za odmerjanje tablet zdravila Kaletra 100/25 mg glede na telesno maso in telesno površino.
Increased plasma concentrations of astemizole and terfenadine.
Večja koncentracija astemizola in terfenadina v plazmi.