FrancophonIA/ELRC3.0 huggingface dataset:
English: Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Croatian: Studija M05-730 je bila randomizirano, otvoreno (''open-label''), multicentrično ispitivanje, u kojem se uspoređivalo liječenje lijekom Kaletra 800/200 mg jednom dnevno u kombinaciji s tenofovirom DF i emtricitabinom naspram lijeka Kaletra 400/100 mg dva puta dnevno plus tenofovir DF i emtricitabin u 664 bolesnika koji prethodno nisu koristili antiretrovirusnu terapiju.
English: See adult dosage recommendation *weight based dosing recommendations are based on limited data ** the volume (ml) of oral solution represents the average dose for the weight range
Croatian: Vidjeti preporuke za doziranje u odraslih *doziranje na osnovu težine je temeljeno na ograničenim podacima
English: Not known Stevens-Johnson syndrome, erythema multiforme
Croatian: Manje često Alopecija, kapilaritis, vaskulitis Nepoznato Stevens-Johnsonov sindrom, erythema multiforme
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Croatian: korištenje alkohola, jaku imunosupresiju, viši indeks tjelesne mase) zabilježeni su slučajevi osteonekroze osobito u bolesnika koji imaju uznapredovalu HIV bolest i/ili su bili dugoročno izloženi kombiniranoj antiretrovirusnoj terapiji (CART).
English: HIV RNA < 50 copies/ml
Croatian: HIV RNK < 50 kopija/ml
English: − 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.
Croatian: - Ako unutar 6 sati od vremena kada ste trebali uzeti lijek primijetite da ste propustili uzeti jednu dozu, što prije uzmite propuštenu dozu, a potom nastavite uzimati lijek prema uobičajenom rasporedu kako Vam je propisao Vaš liječnik.
English: The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen (see section 5.2).
Croatian: Podaci o učinkovitosti govore u prilog doziranju dvaput na dan kao i razlike u farmakokinetičkim parametrima koji značajno govore u prilog doziranju dvaput na dan
English: Increased plasma concentrations of amiodarone and dronedarone.
Croatian: Povišena koncentracija amiodarona i dronedarona u plazmi.
English: HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Croatian: Izdvojeni su izolati HIV-a 1 sa smanjenom osjetljivošću na lopinavir in vitro.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Oral solution - Carton containing 120 ml (2 bottles x 60 ml) oral solution
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Oralna otopina - Kutija koja sadrži 120 ml (2 boce x 60 ml) oralne otopine
English: Increased plasma concentrations of avanafil (see sections 4.4 and 4.5).
Croatian: Povišena koncentracija avanafila u plazmi (vidjeti dijelove 4.4 i 4.5).
English: Phenytoin:
Croatian: Fenitoin:
English: Colchicine
Croatian: Kolhicin
English: Concentrations may be decreased due to CYP3A induction by carbamazepine and phenobarbital.
Croatian: Koncentracije mogu biti smanjene zbog indukcijskog učinka karbamazepina i fenobarbitala na CYP3A.
English: Steady-state concentrations was moderately decreased due to CYP2C9 and CYP2C19 induction by lopinavir/ritonavir.
Croatian: Koncentracije u stanju dinamičke ravnoteže umjereno su se smanjile zbog indukcijskog učinka lopinavira/ritonavira na CYP2C9 i CYP2C19.
English: Caution should be exercised in administering afatinib with Kaletra.
Croatian: Potreban je oprez kada se afatinib primjenjuje zajedno s lijekom Kaletra.
English: The concomitant administration with lurasidone is contraindicated (see section 4.3).
Croatian: Istodobna primjena s lurasidonom je kontraindicirana (vidjeti dio 4.3).
English: Increased plasma concentrations of venetoclax.
Croatian: Povišena koncentracija venetoklaksa u plazmi.
English: • nausea;
Croatian: • mučnina;
English: Increased plasma concentrations of quetiapine which may lead to coma.
Croatian: Povišena koncentracija kvetiapina u plazmi, što može dovesti do kome.
English: Table 6
Croatian: Tablica 6
English: It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir.
Croatian: Ne preporučuje se istodobna primjena lijeka Kaletra i sofosbuvira/velpatasvira/voksilapre vira.
English: Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
Croatian: Sadrži: alkohol (42 % V/V vidjeti uputu o lijeku), kukuruzni sirup bogat fruktozom, propilenglikol, glicerol, polioksil 40 hidrogenirano ricinusovo ulje, kalij (u obliku acesulfamkalija).
English: Ethinyl Oestradiol: ↓
Croatian: Etinilestradiol: ↓
English: 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.
Croatian: Farmakokinetika Kaletra oralne otopine u dozi od 300/75 mg/m² dvaput na dan i 230/57,5 mg/m² dvaput na dan ispitana je u ukupno 53 pedijatrijska bolesnika u dobi od 6 mjeseci do 12 godina.
English: 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
Croatian: Režim liječenja Kaletra oralnom otopinom u dozi od 230/57,5 mg/m2 dvaput na dan bez nevirapina b. Režim liječenja Kaletra oralnom otopinom u dozi od 300/75 mg/m2 dvaput na dan u kombinaciji s nevirapinom c. Kaletra filmom obložene tablete u dozi od 400/100 mg dvaput na dan u stanju dinamičke ravnoteže
English: • weight gain.
Croatian: • povećanje tjelesne težine.
English: 300 ml (5 bottles x 60 ml) oral solution with five 5 ml oral dosing syringes.
Croatian: 300 ml (5 boca x 60 ml) oralne otopine i 5 štrcaljki od 5 ml za primjenu kroz usta.
English: Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Croatian: Erektilna disfunkcija, poremećaj menstrualnog ciklusa - amenoreja, menoragija
English: 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)
Croatian: 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).
English: Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of co-administration of Kaletra and digoxin.
Croatian: Pri istodobnoj primjeni lijeka Kaletra i digoksina nužan je oprez, a preporučuje se i terapijsko praćenje koncentracija digoksina, ukoliko je ono moguće.
English: Rilpivirine (Lopinavir/ritonavir capsule 400/100 mg BID)
Croatian: Rilpivirin (Lopinavir/ritonavir kapsula 400/100 mg BID)
English: Unchanged lopinavir accounted for approximately 2.2% and 19.8% of the administered dose in urine and faeces, respectively.
Croatian: U nepromijenjenu se obliku u urin izlučilo oko 2,2 %, a u feces oko 19,8 % lopinavira.
English: • HIV-1 integrase inhibitor (e.g. raltegravir);
Croatian: • HIV CCR5 antagonisti (npr. maravirok); • HIV-1 inhibitori integraza (npr. raltegravir);
English: 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.
Croatian: Visokom dozom lopinavira/ritonavira (800/200 mg dva puta dnevno) inducirana prolongacija QRS intervala sa 6 ms na 9,5 ms pridonosi QT prolongaciji.
English: Concomitant use of Kaletra with rilpivirine causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Croatian: Istodobna primjena lijeka Kaletra s rilpivirinom uzrokuje povišenje koncentracije rilpivirina u plazmi,
English: The concomitant administration with alfuzosin is contraindicated (see section 4.5).
Croatian: Istodobna primjena s alfuzosinom je kontraindicirana (vidjeti dio 4.5).
English: Pull up the plunger until the black ‘O' ring is on the correct dose ‘ml' mark on the barrel.
Croatian: „O“ prsten ne poravna s točnom oznakom za „ml“ na tijelu štrcaljke.
English: AUC: ↑ 11.86-fold Cmax: ↑ 6.31-fold
Croatian: AUC: ↑ 11,86 puta Cmax: ↑ 6,31 puta
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC).
Croatian: Preporučuje se učestalije praćenje elektrokardiograma i transaminaza (vidjeti dio 4.5 te sažetak opisa svojstava lijeka za bedakilin).
English: For patients with renal impairment (CrCL < 30 ml/min) dose reduction of clarithromycin should be considered (see section 4.4).
Croatian: Smanjenje doze klaritromicina mora se razmotriti u bolesnika s oštećenom funkcijom bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.4).
English: 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.
Croatian: 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.
English: AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold
Croatian: AUC: ↑ 2,71 puta Cmax: ↑ 1,87 puta C24: ↑ 3,58 puta
English: Uncommon Atherosclerosis such as myocardial infarction, atrioventricular block, tricuspid valve incompetence
Croatian: Manje često Ateroskleroza kao što je infarkt miokarda, atrioventrikularni blok, insuficijencija trikuspidalne valvule
English: 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.
Croatian: 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.
English: Kaletra 100 mg/25 mg tablets
Croatian: Kaletra 100 mg/25 mg tablete
English: Replace the bottle cap after each dose.
Croatian: Nakon svake doze vratite zatvarač na bocu.
English: Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.
Croatian: Svakih 1 ml Kaletra oralne otopine sadrži 80 mg lopinavira u kombinaciji s 20 mg ritonavira kao farmakokinetičkog pojačivača.
English: 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.
Croatian: 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
English: Increased plasma concentrations of cisapride.
Croatian: Povišena koncentracija cisaprida u plazmi.
English: • Keep this leaflet.
Croatian: Sačuvajte ovu uputu.
English: Serum concentrations of sofosbuvir, velpatasvir and voxilaprevir may be increased due to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir.
Croatian: Serumske koncentracije sofosbuvira, velpatasvira i voksilaprevira mogu biti povećane zbog inhibicijskog učinka lopinavira/ritoanvira na P-glikoprotein, BCRP i OATP1B1/3.
English: Corticosteroids Dexamethasone
Croatian: Kortikosteroidi Deksametazon
English: If the condition persists or worsens, seek medical attention.
Croatian: Ukoliko simptomi potraju ili se pogoršaju,
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Croatian: Kombinacija može rezultirati u povećanom riziku od kardiovaskularnih nuspojava povezanih sa salmeterolom,
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Croatian: Povišena koncentracija lovastatina i simvastatina u plazmi; time je povišen rizik od miopatije, uključujući rabdomiolizu (vidjeti dio 4.5).
English: Plasma concentrations may be increased due to P-glycoprotein inhibition by lopinavir/ritonavir.
Croatian: Koncentracije u plazmi mogu biti povećane zbog inhibicije Pglikoproteina lopinavirom/ritonavirom.
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
Croatian: Preporučuje se učestalije praćenje elektrokardiograma i transaminaza (vidjeti dio 4.4 te sažetak opisa svojstava lijeka za bedakilin).
English: The co-administration of vorapaxar with Kaletra is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Croatian: Istodobna primjena vorapaksara i lijeka Kaletra se ne preporučuje (vidjeti dio 4.4 i sažetak opisa svojstava lijeka za vorapaksar).
English: 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.
Croatian: 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.
English: Quetiapine
Croatian: Kvetiapin
English: 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.
Croatian: 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.
English: Read the list of medicines below under ‘Other medicines and Kaletra' for information on certain other medicines which require special care.
Croatian: ”Drugi lijekovi i Kaletra” za informacije o posebnim upozorenjima kod uporabe s drugim lijekovima.
English: • enlargement of the lymph nodes;
Croatian: • povećanje limfnih čvorova;
English: or
Croatian: ili
English: b. Tabulated list of adverse reactions
Croatian: b. Tablični prikaz nuspojava
English: Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Croatian: Kaletra 100 mg/25 mg filmom obložene tablete lopinavir/ritonavir
English: 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.
Croatian: ili u sličnim uvjetima, u kojima je osigurano pomno kliničko praćenje i primjereno medicinsko zbrinjavanje u slučaju depresije dišnog sustava i/ili produžene sedacije.
English: Etravirine (Lopinavir/ritonavir tablet 400/100 mg BID)
Croatian: Etravirin (Lopinavir/ritonavir tableta 400/100 mg BID)
English: Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Croatian: Povišena koncentracija vardenafila u plazmi (vidjeti dijelove 4.4 i 4.5).
English: Kaletra 200 mg/50 mg tablets
Croatian: Kaletra 200 mg/50 mg tablete
English: Vorapaxar
Croatian: Vorapaksar
English: 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.
Croatian: 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.
English: AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
Croatian: AUC: ↑ 7,2 puta Cmax: ↑ 4,7 puta Cmin: ↑ 14,4 puta
English: HIV RNA < 400 copies/ml
Croatian: HIV RNK < 400 kopija/ml
English: • swelling or inflammation of the stomach, intestines and colon;
Croatian: • oticanje ili upala trbuha, tankog i debelog crijeva;
English: Recommended number of 100/25 mg tablets twice-daily
Croatian: 100/25 mg dva puta dnevno
English: Two pack sizes are available: - 1 bottle of 120 tablets - multipack containing 360 (3 bottles of 120) film-coated tablets
Croatian: - 1 boca sa 120 tableta - Višestruko pakiranje sadrži 360 tableta (3 boce sa 120) filmom obloženih tableta
English: Omeprazole: ↔ Lopinavir: ↔
Croatian: Dasabuvir: ↔ Lopinavir: ↔
English: AUC: ↑ 6.10-fold Cmax: ↑ 4.76-fold Ctrough: ↑ 12.33-fold
Croatian: AUC: ↑ 6,10 puta Cmax: ↑ 4,76 puta Cnajniži: ↑ 12,33 puta
English: AUC: ↔ Cmin: ↑ 3.5-fold Cmax: ↓
Croatian: AUC: ↔ Cmin: ↑ 3,5 puta Cmax: ↓
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava Često
English: Paediatric dosing guidelines with concomitant efavirenz or nevirapine
Croatian: Smjernice za pedijatrijsko doziranje s istodobnom primjenom efavirenza ili nevirapina
English: 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.
Croatian: 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.
English: Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A.
Croatian: Kaletra sadrži lopinavir i ritonavir, a oba su inhibitori P450 izoforme CYP3A.
English: An oral solution is available to patients who have difficulty swallowing.
Croatian: Bolesnicima s otežanim gutanjem dostupna je oralna otopina.
English: Refer to the ceritinib SmPC for dosage adjustment recommendations.
Croatian: Vidjeti sažetak opisa svojstava lijeka za ceritinib za preporuke vezane uz prilagodbu doze.
English: Carbamazepine and phenobarbital levels should be monitored when co-administering with Kaletra.
Croatian: Koncentracije karbamazepina i fenobarbitala se moraju pratiti pri njihovoj istodobnoj primjeni s lijekom Kaletra.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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).
English: Encorafenib
Croatian: Enkorafenib
English: Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Croatian: Svaka tableta lijeka Kaletra sadrži 200 mg lopinavira i 50 mg ritonavira
English: Concomitant administration of glecaprevir/pibrentasvir and Kaletra is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Croatian: Kaletra se ne preporučuje zbog povećanog rizika od porasta razine ALT-a koji je povezan s povećanom izloženošću glekapreviru.
English: Analysis of resistance in ARV-naïve patients
Croatian: Analiza rezistencije u bolesnika liječenih inhibitorima proteaze
English: • If the dose is up to 2 ml - use the 2 ml oral dosing syringe to prepare a dose.
Croatian: • Ako doza iznosi do 2 ml, odmjerite je štrcaljkom od 2 ml za primjenu kroz usta.
English: HIV RNA < 400 copies/ml*
Croatian: HIV RNK < 400 kopija/ml*
English: Analgesics Fentanyl
Croatian: Analgetici Fentanil
English: 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
Croatian: 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
English: Co-administration of Kaletra with rifampicin is not recommended.
Croatian: Ne preporučuje se istovremeno davanje lijeka Kaletra s rifampicinom.
English: Kaletra 200 mg film-coated tablets and Kaletra 100 mg/25 mg film-coated tablets: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Croatian: Kaletra 200 mg/50 mg filmom obložene tablete i Kaletra 100 mg/25 mg filmom obložene tablete: AbbVie Deutschland GmbH & Co.
English: 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).
Croatian: 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,
English: 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).
Croatian: Istodobna primjena lijeka Kaletra s astemizolom i terfenadinom je kontraindicirana jer može povećati rizik od ozbiljnih aritmija uzrokovanih tim lijekovima (vidjeti dio 4.3).
English: Antiarrhythmics Amiodarone, Dronedarone
Croatian: Antiaritmici Amiodaron, dronedaron Amiodaron, dronedaron:
English: Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated (see section 4.3).
Croatian: Istodobna primjena elbasvira/grazoprevira i lijeka Kaletra je kontraindicirana (vidjeti dio 4.3).
English: What you need to know before you or your child takes Kaletra Do not take Kaletra if:
Croatian: Vi ili Vaše dijete počnete uzimati lijek Kaletra Nemojte uzimati lijek Kaletra:
English: 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.
Croatian: Dozu lamotrigina će možda trebati povećati ako se dodaje Kaletra, ili smanjiti ako se Kaletra prestaje uzimati; stoga treba provesti praćenje lamotrigina u plazmi,