natgillin/translations-raw huggingface dataset:
Concomitant administration of Kaletra and pimozide is contraindicated as it may increase the risk of serious haematologic abnormalities or other serious adverse effects from this agent (see section 4.3)
Istodobna primjena lijeka Kaletra i pimozida je kontraindicirana jer može povećati rizik od ozbiljnih hematoloških abnormalnosti ili drugih ozbiljnih nuspojava tog lijeka (vidjeti dio 4.3).
Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of co-administration of Kaletra and digoxin.
Pri istodobnoj primjeni lijeka Kaletra i digoksina nužan je oprez, a preporučuje se i terapijsko praćenje koncentracija digoksina, ukoliko je ono moguće.
Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Rilpivirin (Lopinavir/ritonavir kapsula 400/100 mg BID)
Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
U nepromijenjenu se obliku u urin izlučilo oko 2,2 %, a u feces oko 19,8 % lopinavira.
• HIV-1 integrase inhibitor (e.g. raltegravir);
• HIV CCR5 antagonisti (npr. maravirok); • HIV-1 inhibitori integraza (npr. raltegravir);
The induced QRS interval prolongation from 6 ms to 9.5 ms with high dose lopinavir/ritonavir (800/200 mg twice daily) contributes to QT prolongation.
Visokom dozom lopinavira/ritonavira (800/200 mg dva puta dnevno) inducirana prolongacija QRS intervala sa 6 ms na 9,5 ms pridonosi QT prolongaciji.
Concomitant use of Kaletra with rilpivirine causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Istodobna primjena lijeka Kaletra s rilpivirinom uzrokuje povišenje koncentracije rilpivirina u plazmi,
The concomitant administration with alfuzosin is contraindicated (see section 4.5).
Istodobna primjena s alfuzosinom je kontraindicirana (vidjeti dio 4.5).
Pull up the plunger until the black ‘O' ring is on the correct dose ‘ml' mark on the barrel.
„O“ prsten ne poravna s točnom oznakom za „ml“ na tijelu štrcaljke.
AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold
AUC: ↑ 11,86 puta Cmax: ↑ 6,31 puta
More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC).
Preporučuje se učestalije praćenje elektrokardiograma i transaminaza (vidjeti dio 4.5 te sažetak opisa svojstava lijeka za bedakilin).
For patients with renal impairment (CrCL < 30 ml/min) dose reduction of clarithromycin should be considered (see section 4.4).
Smanjenje doze klaritromicina mora se razmotriti u bolesnika s oštećenom funkcijom bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.4).
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.
Istodobna primjena drugih lijekova: efavirenz ili nevirapin Sljedeća tablica sadrži smjernice za doziranje u djece Kaletra 100/25 mg tableta, korištenih u kombinaciji s efavirenzom ili nevirapinom, temeljeno na površini tijela.
AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold
AUC: ↑ 2,71 puta Cmax: ↑ 1,87 puta C24: ↑ 3,58 puta
Uncommon Atherosclerosis such as myocardial infarction, atrioventricular block, tricuspid valve incompetence
Manje često Ateroskleroza kao što je infarkt miokarda, atrioventrikularni blok, insuficijencija trikuspidalne valvule
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.
Pri dozama od 230/57,5 mg/m² dvaput na dan bez nevirapina i 300/75 mg/m² dvaput na dan s nevirapinom koncentracije lopinavira u plazmi bile su slične onima u odraslih bolesnika koji su primali dozu od 400/100 mg dvaput na dan bez nevirapina.
Kaletra 100 mg/25 mg tablets
Kaletra 100 mg/25 mg tablete
Replace the bottle cap after each dose.
Nakon svake doze vratite zatvarač na bocu.
Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Svakih 1 ml Kaletra oralne otopine sadrži 80 mg lopinavira u kombinaciji s 20 mg ritonavira kao farmakokinetičkog pojačivača.
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.
Utjecaj hrane na apsorpciju nakon peroralne primjene Primjena jedne 400/100 mg doze Kaletra tableta u uvjetima nakon obroka (hrana s visokim sadržajem masti, 872 kcal, 56% iz masti) u usporedbi sa stanjem natašte nije pokazala značajne promjene u Cmax i
Increased plasma concentrations of cisapride.
Povišena koncentracija cisaprida u plazmi.
• Keep this leaflet.
Sačuvajte ovu uputu.
Serum concentrations of sofosbuvir, velpatasvir and voxilaprevir may be increased due to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir.
Serumske koncentracije sofosbuvira, velpatasvira i voksilaprevira mogu biti povećane zbog inhibicijskog učinka lopinavira/ritoanvira na P-glikoprotein, BCRP i OATP1B1/3.
Corticosteroids Dexamethasone
Kortikosteroidi Deksametazon
If the condition persists or worsens, seek medical attention.
Ukoliko simptomi potraju ili se pogoršaju,
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Kombinacija može rezultirati u povećanom riziku od kardiovaskularnih nuspojava povezanih sa salmeterolom,
Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Povišena koncentracija lovastatina i simvastatina u plazmi; time je povišen rizik od miopatije, uključujući rabdomiolizu (vidjeti dio 4.5).
Plasma concentrations may be increased due to P-glycoprotein inhibition by lopinavir/ritonavir.
Koncentracije u plazmi mogu biti povećane zbog inhibicije Pglikoproteina lopinavirom/ritonavirom.
More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
Preporučuje se učestalije praćenje elektrokardiograma i transaminaza (vidjeti dio 4.4 te sažetak opisa svojstava lijeka za bedakilin).
The co-administration of vorapaxar with Kaletra is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Istodobna primjena vorapaksara i lijeka Kaletra se ne preporučuje (vidjeti dio 4.4 i sažetak opisa svojstava lijeka za vorapaksar).
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.
U skupini koja je primala lijek jedanput dnevno nije zabilježena rezistencija na lopinavir niti kod jednog bolesnika, dok je u skupini koja je primala lijek dva puta dnevno kod 1 bolesnika koji je na početku pokazivao značajnu rezistenciju na inhibitor proteaze zabilježena dodatna rezistencija na lopinavir u studiji.
Quetiapine
Kvetiapin
Across studies, administration of Kaletra 400/100 mg twice daily yields mean steady-state lopinavir plasma concentrations 15 to 20-fold higher than those of ritonavir in HIV-infected patients.
Ispitivanja su pokazala da se u bolesnika zaraženih HIV-om pri primjeni lijeka Kaletra u dozi od 400/100 mg dvaput na dan postižu srednje vrijednosti plazmatske koncentracije lopinavira, koje su u stanju ravnoteže 15-20 puta veće od koncentracija ritonavira.
Read the list of medicines below under ‘Other medicines and Kaletra' for information on certain other medicines which require special care.
”Drugi lijekovi i Kaletra” za informacije o posebnim upozorenjima kod uporabe s drugim lijekovima.
• enlargement of the lymph nodes;
• povećanje limfnih čvorova;
b. Tabulated list of adverse reactions
b. Tablični prikaz nuspojava
Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Kaletra 100 mg/25 mg filmom obložene tablete lopinavir/ritonavir
If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
ili u sličnim uvjetima, u kojima je osigurano pomno kliničko praćenje i primjereno medicinsko zbrinjavanje u slučaju depresije dišnog sustava i/ili produžene sedacije.
Etravirine (Lopinavir/ritonavir tablet 400/100 mg BID)
Etravirin (Lopinavir/ritonavir tableta 400/100 mg BID)
Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Povišena koncentracija vardenafila u plazmi (vidjeti dijelove 4.4 i 4.5).
Kaletra 200 mg/50 mg tablets
Kaletra 200 mg/50 mg tablete
Vorapaxar
Vorapaksar
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.
koncentracije lopinavira u plazmi bile su slične onima u odraslih bolesnika koji su primali režim liječenja dozom od 400/100 mg dvaput na dan bez nevirapina.
AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
AUC: ↑ 7,2 puta Cmax: ↑ 4,7 puta Cmin: ↑ 14,4 puta
HIV RNA < 400 copies/ml
HIV RNK < 400 kopija/ml
• swelling or inflammation of the stomach, intestines and colon;
• oticanje ili upala trbuha, tankog i debelog crijeva;
Recommended number of 100/25 mg tablets twice-daily
100/25 mg dva puta dnevno
Two pack sizes are available: - 1 bottle of 120 tablets - multipack containing 360 (3 bottles of 120) film-coated tablets
- 1 boca sa 120 tableta - Višestruko pakiranje sadrži 360 tableta (3 boce sa 120) filmom obloženih tableta
Omeprazole: ↔ Lopinavir: ↔
Dasabuvir: ↔ Lopinavir: ↔
AUC: ↑ 6.10-fold Cmax: ↑ 4.76-fold Ctrough: ↑ 12.33-fold
AUC: ↑ 6,10 puta Cmax: ↑ 4,76 puta Cnajniži: ↑ 12,33 puta
AUC: ↔ Cmin: ↑ 3.5-fold Cmax: ↓
AUC: ↔ Cmin: ↑ 3,5 puta Cmax: ↓
Nervous system disorders
Poremećaji živčanog sustava Često
Paediatric dosing guidelines with concomitant efavirenz or nevirapine
Smjernice za pedijatrijsko doziranje s istodobnom primjenom efavirenza ili nevirapina
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.
Serija in vitro i in vivo ispitivanja, uključujući i Amesov bakterijski test reverzne mutacije, test mišjeg limfoma, test mišjih mikronukleusa i test kromosomskih aberacija ljudskih limfocita, nije pokazala mutagenost niti klastogenost lopinavira/ritonavira.
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Kaletra sadrži lopinavir i ritonavir, a oba su inhibitori P450 izoforme CYP3A.
An oral solution is available to patients who have difficulty swallowing.
Bolesnicima s otežanim gutanjem dostupna je oralna otopina.
Refer to the ceritinib SmPC for dosage adjustment recommendations.
Vidjeti sažetak opisa svojstava lijeka za ceritinib za preporuke vezane uz prilagodbu doze.
Carbamazepine and phenobarbital levels should be monitored when co-administering with Kaletra.
Koncentracije karbamazepina i fenobarbitala se moraju pratiti pri njihovoj istodobnoj primjeni s lijekom Kaletra.
One hundred patients were originally treated with Kaletra in the study (including 51 patients receiving 400/100 mg twice daily and 49 patients at either 200/100 mg twice daily or 400/200 mg twice daily).
bolesnik primao je 400/100 mg dva puta dnevno, a 49 bolesnika primalo je 200/100 mg dva puta dnevno ili 400/200 mg dva puta dnevno).
Multiple dosing with 400/100 mg Kaletra twice daily for 2 weeks and without meal restriction produced a mean ± SD lopinavir peak plasma concentration (Cmax) of 12.3 ± 5.4 µg/ml, occurring approximately 4 hours after administration.
Pri uzimanju lijeka Kaletra u dozi od 400/100 mg dvaput na dan tijekom 2 tjedna, bez ograničenja uzimanja hrane, vršna je koncentracija lopinavira u plazmi (Cmax) postignuta oko 4 sata nakon uzimanja, a iznosila je 12,3 ± 5,4 μg/ml (srednja vrijednost ± SD).
Encorafenib
Enkorafenib
Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Svaka tableta lijeka Kaletra sadrži 200 mg lopinavira i 50 mg ritonavira
Concomitant administration of glecaprevir/pibrentasvir and Kaletra is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Kaletra se ne preporučuje zbog povećanog rizika od porasta razine ALT-a koji je povezan s povećanom izloženošću glekapreviru.
Analysis of resistance in ARV-naïve patients
Analiza rezistencije u bolesnika liječenih inhibitorima proteaze
• If the dose is up to 2 ml - use the 2 ml oral dosing syringe to prepare a dose.
• Ako doza iznosi do 2 ml, odmjerite je štrcaljkom od 2 ml za primjenu kroz usta.
HIV RNA < 400 copies/ml*
HIV RNK < 400 kopija/ml*
Analgesics Fentanyl
Analgetici Fentanil
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
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija višestrukog pakiranja od 120 (3 kutije s po 40 filmom obloženih tableta od 200 mg/50 mg) - s plavim okvirom
Co-administration of Kaletra with rifampicin is not recommended.
Ne preporučuje se istovremeno davanje lijeka Kaletra s rifampicinom.
Kaletra 200 mg film-coated tablets and Kaletra 100 mg/25 mg film-coated tablets: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Kaletra 200 mg/50 mg filmom obložene tablete i Kaletra 100 mg/25 mg filmom obložene tablete: AbbVie Deutschland GmbH & Co.
Postmarketing life-threatening cases of cardiac toxicity (including complete atrioventricular (AV) block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution (see sections 4.3 and 4.9).
Tijekom praćenja lijeka nakon stavljanja u promet zabilježeni su po život opasni slučajevi srčane toksičnosti (uključujući potpuni atrioventrikularni (AV) blok, bradikardiju i kardiomiopatiju), laktičke acidoze, akutnog zatajenja bubrega, depresije središnjeg živčanog sustava i komplikacija dišnog sustava sa smrtnim ishodom,
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).
Istodobna primjena lijeka Kaletra s astemizolom i terfenadinom je kontraindicirana jer može povećati rizik od ozbiljnih aritmija uzrokovanih tim lijekovima (vidjeti dio 4.3).
Antiarrhythmics Amiodarone, Dronedarone
Antiaritmici Amiodaron, dronedaron Amiodaron, dronedaron:
Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section 4.3).
Istodobna primjena elbasvira/grazoprevira i lijeka Kaletra je kontraindicirana (vidjeti dio 4.3).
What you need to know before you or your child takes Kaletra Do not take Kaletra if:
Vi ili Vaše dijete počnete uzimati lijek Kaletra Nemojte uzimati lijek Kaletra:
In patients starting or stopping Kaletra while currently taking maintenance dose of lamotrigine: lamotrigine dose may need to be increased if Kaletra is added, or decreased if Kaletra is discontinued; therefore plasma lamotrigine monitoring should be conducted, particularly before and during 2 weeks after starting or stopping Kaletra, in order to see if lamotrigine dose adjustment is needed.
Dozu lamotrigina će možda trebati povećati ako se dodaje Kaletra, ili smanjiti ako se Kaletra prestaje uzimati; stoga treba provesti praćenje lamotrigina u plazmi,
Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor's supervision (see Other medicines and Kaletra section);
Sildenafil koji se koristi za liječenje erektilne disfunkcije može se koristiti samo pod liječničkim nadzorom (pogledajte dio Drugi lijekovi i Kaletra); • pripravke koji sadrže gospinu travu (Hypericum perforatum).
Oral contraceptives Ethinyl Oestradiol
Oralni kontraceptivi Etinilestradiol
• steroids (e.g. budesonide, dexamethasone, fluticasone propionate, ethinyl oestradiol,
• steroidi (npr. budezonid, deksametazon, flutikazonpropionat, etinilestradiol, triamcinolon).
Apalutamide
Apalutamid
Nucleoside/Nucleotide reverse transcriptase inhibitors (NRTIs) Stavudine, Lamivudine Lopinavir: ↔
Nukleozidni/nukleotidni inhibitori reverzne transkriptaze (NRTI; engl. nucleoside/nucleotide reverse transcriptase inhibitor)
Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Studija M98-863 bilo je randomizirano, dvostruko slijepo ispitivanje lijeka Kaletra (400/100 mg dvaput na dan) u usporedbi s nelfinavirom (750 mg triput na dan) plus stavudin i lamivudin u 653 bolesnika bez prethodne antiretrovirusne terapije.
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
Važno je da Kaletra tablete progutate cijele, nemojte ih žvakati, lomiti ili drobiti.
• If the ‘ml' mark on the black ‘O' ring is less than the prescribed dose, draw up more solution to the prescribed dose.
• Ako je broj „ml“ u ravnini s crnim „O“ prstenom manji od propisane doze, uvucite još otopine kako biste dobili propisanu dozu.
Caution should be exercised in administering ceritinib with Kaletra.
Potreban je oprez kada se ceritinib primjenjuje zajedno s lijekom Kaletra.
Kaletra tablets are administered orally and must be swallowed whole and not chewed, broken or crushed.
Kaletra tablete se primjenjuju peroralno i moraju se progutati cijele, ne smiju se žvakati, lomiti ili drobiti.
Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Svaka tableta lijeka Kaletra sadrži 100 mg lopinavira i 25 mg ritonavira
Uncommon Creatinine clearance decreased, nephritis, haematuria
Manje često Smanjenje klirensa kreatinina, nefritis, hematurija
Kaletra is also supplied as 100 mg/25 mg film-coated tablets.
Kaletra je također dostupna u obliku 100 mg/25 mg filmom obloženih tableta.
Due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
Zbog inhibicije CYP3A i Pgp-a lopinavirom/ritonavirom.
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).
Istodobna primjena lijeka Kaletra i kolhicina je kontraindicirana kod bolesnika s oštećenjem funkcije bubrega i/ili jetre jer može doći do povećanja ozbiljnih i/ili po život opasnih reakcija povezanih s kolhicinom poput neuromuskularne toksičnosti (uključujući rabdomiolizu) (vidjeti dijelove 4.3 i 4.4).
Body weight (kg) Twice daily oral solution dose (dose in mg/kg)
Doziranje oralne otopine dvaput na dan (doza u mg)
Large decreases in lopinavir concentrations may be observed due to CYP3A induction by rifampicin.
Moguće su jako smanjene koncentracije lopinavira zbog indukcijskog učinka rifampicina na CYP3A.
The concomitant administration of Kaletra and ranolazine is contraindicated (see section 4.3).
Istodobna primjena lijeka Kaletra i ranolazina je kontraindicirana (vidjeti dio 4.3).
Concomitant administration of Kaletra and cisapride is contraindicated as it may increase the risk of serious arrhythmias from this agent (see section 4.3).
Istodobna primjena lijeka Kaletra i cisaprida je kontraindicirana jer može povećati rizik od ozbiljnih aritmija uzrokovanih tim lijekom (vidjeti dio 4.3).
It belongs to a group of medicines called protease inhibitors.
Kaletra je antiretrovirusni lijek i spada u skupinu lijekova koje nazivamo inhibitorima proteaze.
Median baseline CD4 cell count was 220 cells/mm3 (range13 to 1030 cells/mm3).
Na početku je ispitivanja medijan broja CD4 stanica iznosio 220 stanica/mm³ (raspon 13 do 1030 stanica/mm³).
Concentrations may be increased due to CYP3A4 inhibition by lopinavir/ritonavir.
Koncentracije mogu biti povećane zbog inhibicije CYP3A4 lopinavirom/ritonavirom.
Concentrations may be affected when co-administered with lopinavir/ritonavir due to CYP2C9 induction.
Pri istodobnoj primjeni s lopinavirom/ritonavirom moguć je utjecaj na koncentracije varfarina zbog indukcije CYP2C9.
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro.
Kaletra sadrži lopinavir i ritonavir, koji su oba inhibitori P450 izoforme CYP3A in vitro.
• 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.
• Mučninu, povraćanje, bol u trbuhu jer to može upućivati na pankreatitis (upalu gušterače) za koji povećana koncentracija triglicerida (masnoće u krvi) predstavlja rizičan faktor.
Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Kaletra 200 mg/50 mg filmom obložene tablete lopinavir/ritonavir
LIST OF EXCIPIENTS
Opis izabranih nuspojava
Increased risk of side-effects (respiratory depression, sedation) due to higher plasma concentrations because of CYP3A4 inhibition by lopinavir/ritonavir.
(depresija disanja, sedacija) uslijed viših koncentracija u plazmi, nastalih zbog inhibicije CYP3A4 lopinavirom/ritonavirom.
Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir.
U bolesnika liječenih kolhicinom i snažnim inhibitorima CYP3A poput ritonavira zabilježene su po život opasne i fatalne interakcije lijekova.
Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from this agent (see section 4.5).
Time je povišen rizik od ozbiljnih hematoloških poremećaja i ostalih ozbiljnih nuspojava uzrokovanih ovom tvari (vidjeti dio 4.5).
Contents of the pack and other information
Kako čuvati lijek Kaletra Sadržaj pakiranja i druge informacije
One-hundred thirteen nelfinavir-treated patients and 74 lopinavir/ritonavir-treated patients had an HIV RNA above 400 copies/ml while on treatment from Week 24 through Week 96.
RNK iznad 400 kopija/ml tijekom liječenja od 24 do 96 tjedna.
Copovidone, sorbitan laurate, colloidal anhydrous silica, sodium stearyl fumarate.
Kopovidon, sorbitanlaurat, bezvodni, koloidni silicijev dioksid, natrijev stearilfumarat.
HIV RNA < 400 copies/ml* Median change from baseline in CD4+ T-cell count (cells/mm3)
HIV RNK < 400 kopija/ml* Medijan promjene od početnog broja CD4+ T-stanica (stanica/mm3)
• antifungals (e.g. ketoconazole, itraconazole, voriconazole);
• lijekovi za liječenje gljivičnih infekcija (npr. ketokonazol, itrakonazol, vorikonazol);
• If the ‘ml' mark on the black ‘O' ring is more than the prescribed dose, push the plunger to the prescribed dose.
• Ako je broj „ml“ u ravnini s crnim „O“ prstenom veći od propisane doze, potiskujte klip dok se prsten ne poravna s oznakom za propisanu dozu.
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 bolesnici koji su prethodno uzimali druge antivirusne lijekove mogu uzimati Kaletra tablete jednom dnevno u dozi od 800 mg/200
(increase is indicated as “↑”, decrease as “↓”, no change as “↔”,once daily as “QD”, twice daily as
U tablici su navedene interakcije između lijeka Kaletra i istodobno primijenjenih lijekova (povišenje je označeno strelicom „↑“, sniženje strelicom „↓“, bez promjene strelicom „↔“, doziranje jedanput na dan oznakom „QD“, dvaput na dan oznakom „BID“, a triput na dan oznakom „TID“).