FrancophonIA/ELRC3.0 huggingface dataset:
English: For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics.
Croatian: Za djecu koja ne mogu gutati tablete koristite sažetak opisa svojstava lijeka za Kaletra oralnu otopinu.
English: How to take Kaletra
Croatian: Kako uzimati lijek Kaletra
English: 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.
Croatian: Ispitivanja in vitro pokazala su da su lopinavir/ritonavir pri najvećim koncentracijama inhibirali klonirane kalijeve kanale ljudskog srca (HERG) za 30 %, a te su koncentracije bile 7 puta veće od ukupnih koncentracija lopinavira i 15 puta veće od vršnih koncentracija lopinavira, koje se postižu u plazmi ljudi pri najvećim preporučenim terapijskim dozama.
English: Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of lopinavir/ritonavir.
Croatian: Apalutamid je umjeren do snažan induktor CYP3A4 što može dovesti do smanjene izloženosti lopinaviru/ritonaviru.
English: 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).
Croatian: Istodobna primjena lijeka Kaletra s fusidatnom kiselinom je kontraindicirana kod dermatoloških indikacija zbog povećanog rizika od štetnih događaja povezanih s fusidatnom kiselinom, osobito rabdomiolize (vidjeti dio 4.3).
English: • If the dose is between 2 ml and 5 ml - use the 5 ml oral dosing syringe to prepare a dose.
Croatian: • Ako doza iznosi između 2 ml i 5 ml, odmjerite je štrcaljkom od 5 ml za primjenu kroz usta.
English: 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
Croatian: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, Ujedinjeno Kraljevstvo AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska AbbVie Deutschland GmbH & Co.
English: Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5).
Croatian: Povišen rizik od sindroma tumorske lize pri uvođenju liječenja i tijekom razdoblja povećavanja doze (vidjeti dio 4.5).
English: Infants should be monitored closely for toxicity related to Kaletra oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, central nervous system (CNS) depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis.
Croatian: Djecu se mora pomno pratiti radi toksičnosti povezane s primjenom Kaletra oralne otopine uključujući: hiperosmolalnost, s ili bez laktičke acidoze, renalnu toksičnost, depresiju središnjeg živčanog sustava (CNS) (uključujući stupor, komu i apneju),
English: The treatment regimen was zidovudine plus lamivudine plus 300 mg lopinavir/75 mg ritonavir per m2 twice daily until 6 months of age, then 230 mg lopinavir/57.5 mg ritonavir per m2 twice daily.
Croatian: Režim liječenja obuhvaćao je zidovudin plus lamivudin plus 300 mg lopinavira/75 mg ritonavira po m2 dvaput na dan do 6. mjeseca života, nakon čega se primjenjivalo 230 mg lopinavira/57,5 mg ritonavira po m2 dvaput na dan.
English: If this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations.
Croatian: Ocijeni li se da je ta istodobna primjena neizbježna, potrebno je vidjeti sažetak opisa svojstava lijeka za abemaciklib za preporuke vezane uz prilagodbu doze.
English: Patients were administered at least two nucleoside/nucleotide reverse transcriptase inhibitors selected by the investigator.
Croatian: Prema odabiru ispitivača bolesnicima su davana najmanje dva nukleozidna/nukleotidna inhibitora reverzne transkriptaze.
English: − Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).
Croatian: Obavijestite svog liječnika ako se pojave mučnina, povraćanje ili bol u trbuhu jer to mogu biti simptomi pankreatitisa (upale gušterače).
English: 6/75 (8%) patients demonstrated new primary protease inhibitor mutations (codons 30, 32, 48, 50, 82, 84, 90), as did 12/77 (16%) patients in the BID group.
Croatian: U skupini koja je primala lijek jedanput dnevno kod 6/75 (8%) bolesnika zabilježene su nove primarne mutacije inhibitora proteaze (kodoni 30, 32, 48, 50, 82, 84, 90) kao i kod 12/77 (16%) bolesnika iz skupine koja je primala lijek dva puta dnevno.
English: Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations.
Croatian: Pri uvođenju digoksina bolesnicima koji već uzimaju lijek Kaletra, koncentracije digoksina vjerojatno će porasti manje nego što se očekuje.
English: Concomitant use of avanafil or vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3).
Croatian: Istodobna primjena avanafila ili vardenafila s lopinavirom/ritonavirom je kontraindicirana (vidjeti dio 4.3).
English: Anti-infectives Fusidic acid
Croatian: Antiinfektivi Fusidatna kiselina
English: Data from clinical trials in children below 2 years of age include the pharmacokinetics of Kaletra 300/75 mg/m2 twice daily studied in a total of 31 paediatric patients, ranging in age from 14 days to 6 months.
Croatian: Podaci iz kliničkih ispitivanja u djece mlađe od 2 godine uključuju farmakokinetiku lijeka Kaletra u dozi od 300/75 mg/m² dvaput na dan, koja se ispitivala u ukupno 31 pedijatrijskog bolesnika u dobi od 14 dana do 6 mjeseci.
English: 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).
Croatian: Bolesnici su bili podijeljeni u grupe u omjeru 1:1 na taj način da su jedni primali lijek Kaletra 800/200 mg jednom dnevno (n=333), a drugi lijek Kaletra 400/100 mg dva puta dnevno (n=331).
English: Co-administration of ibrutinib and Kaletra should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu ibrutiniba i lijeka Kaletre.
English: Antianginal
Croatian: Antianginici
English: Concomitant use of Kaletra with apalutamide is not recommended.
Croatian: Istodobna primjena lijeka Kaletra s apalutamidom se ne preporučuje.
English: Lipid lowering agents Lovastatin and Simvastatin
Croatian: Lijekovi za snižavanje lipida Lovastatin i simvastatin
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Croatian: Zabilježeni su slučajevi osteonekroze, posebno kod bolesnika s opće poznatim faktorima rizika, uznapredovalom HIV bolesti ili kod dugotrajnog uzimanja kombinirane antiretroviralne terapije
English: ≥ 0.5 to < 0.9
Croatian: ≥ 0,5 do < 0,9
English: Lopinavir/ritonavir plasma concentrations may decrease due to CYP3A4 induction by bosentan.
Croatian: Mogu se smanjiti plazmatske koncentracije lopinavira/ritonavira zbog indukcije CYP3A4 bosentanom.
English: A dose adjustment of Kaletra 400 mg/400 mg (i.e.
Croatian: Prilagođavanjem doze lijeka Kaletra na 400 mg/400 mg (tj.
English: Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Croatian: Prema postojećim smjernicama za liječenje, dvojno liječenje inhibitorima proteaza općenito se ne preporučuje.
English: Outcomes at Week 360: Study M97-720
Croatian: Rezultati u 360. tjednu: studija M97-720
English: Afatinib (Ritonavir 200 mg twice daily)
Croatian: Afatinib (Ritonavir 200 mg dvaput na dan)
English: M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of once-daily and twice-daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Croatian: M06-802 je bilo randomizirano, otvoreno ispitivanje koje je uspoređivalo sigurnost, podnošljivost i antivirusnu aktivnost kod doziranja lopinavir/ritonavir tableta jednom dnevno i doziranja dva puta dnevno kod 599 ispitanika s mjerljivom količinom virusa za vrijeme primanja njihove antivirusne terapije.
English: In contrast, similar concentrations of lopinavir/ritonavir demonstrated no repolarisation delay in the canine cardiac Purkinje fibres.
Croatian: Nasuprot tome, lopinavir/ritonavir u tim sličnim koncentracijama nisu odgodili repolarizaciju Purkinjeovih vlakana iz psećeg srca.
English: The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section
Croatian: Istodobna primjena s fusidatnom kiselinom je kontraindicirana kod dermatoloških infekcija (vidjeti dio
English: (Ritonavir 200 mg twice daily)
Croatian: (Ritonavir 200 mg dvaput dnevno)
English: 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.
Croatian: U odraslih bolesnika, u kojih se doziranje jednom dnevno smatra nužnim za liječenje bolesnika, Kaletra tablete se mogu primijeniti u dozi od 800/200 mg (odnosno četiri tablete od 200/50 mg) jednom dnevno s ili bez hrane.
English: Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse reactions.
Croatian: Štoviše, Kaletra može povisiti koncentracije tih istodobno primijenjenih lijekova, zbog čega se može povećati i učestalost srčanih nuspojava povezanih s tim lijekovima.
English: The mean steady-state trough concentration prior to the morning dose was 8.1 ± 5.7 µg/ml.
Croatian: Srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže, prije jutarnje doze, iznosila je 8,1 ± 5,7 μg/ml.
English: − calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine);
Croatian: − digoksin; − antagoniste kalcijevih kanala (npr. felodipin, nifedipin, nikardipin);
English: The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/100 mg twice daily and supratherapeutic 800/200 mg twice daily LPV/r, respectively.
Croatian: Najveće srednje vrijednosti razlika QTcF-a (gornja granica intervala pouzdanosti od 95%) u odnosu na placebo bile su 3,6 (6,3) u bolesnika koji su uzimali 400/100 mg lopinavira/ritonavira dva puta dnevno i 13,1 (15,8) u bolesnika koji su uzimali supraterapijsku dozu od 800/200 mg lopinavira/ritonavira dva puta dnevno.
English: The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing.
Croatian: Jednodnevni režim doziranja mora biti ograničen na one odrasle bolesnike koji imaju vrlo malo mutacija povezanih s inhibitorom proteaze (IP) (t.j. manje od 3 mutacije IP u skladu s rezultatima kliničkog ispitivanja, vidjeti dio 5.1 za potpuni opis populacije) te se mora voditi računa o riziku smanjene održivosti supresije virusa (vidjeti dio 5.1)
English: ≥ 0.5 to < 0.8
Croatian: ≥ 0,5 do < 0,8
English: HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during Kaletra therapy.
Croatian: HIV-1 inkubiran je in vitro s lopinavirom samim te s lopinavirom i ritonavirom u omjerima koncentracija koje su oponašale omjere koncentracija u plazmi izmjerene pri uzimanju lijeka Kaletra.
English: 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.
Croatian: Neki od brojnih čimbenika rizika za razvoj ove bolesti mogu biti i duljina kombinirane antiretrovirusne terapije, uporaba kortikosteroida, konzumacija alkohola, teška imunosupresija (smanjenje aktivnosti imunološkog sustava), povišen indeks tjelesne mase i dr.
English: The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/abnormal stool.
Croatian: Klinički znakovi predoziranja zabilježeni u pasa obuhvaćaju pojačanu salivaciju, povraćanje i proljev/abnormalnu stolicu.
English: Abacavir, Zidovudine Abacavir, Zidovudine: Concentrations may be reduced due to increased glucuronidation by lopinavir/ritonavir.
Croatian: Abakavir, zidovudin Abakavir, zidovudin: koncentracije mogu biti smanjene zbog pojačane glukuronidacije izazvane lopinavirom/ritonavirom.
English: In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
Croatian: U odsutnosti ljudskog seruma srednja vrijednost IC50 lopinavira prema pet različitih laboratorijskih sojeva HIV-a 1 iznosila je 19 nM.
English: The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Croatian: puta u IC50 u usporedbi s početnim izolatima (povećanje od 6,2 puta do 43 puta, u usporedbi s divljim tipom virusa).
English: The combination of Kaletra with atorvastatin is not recommended.
Croatian: Kombinacija lijeka Kaletra s atorvastatinom se ne preporučuje.
English: Bedaquiline: AUC: ↑ 22%
Croatian: Bedakilin: AUC: ↑ 22%
English: Mean increase from baseline in CD4+ T-cell count (cells/mm3) * intent to treat analysis where patients with missing values are considered virologic failures
Croatian: Srednja vrijednost porasta od početnog broja CD4+ T-stanica (stanica/mm3) * analiza svih bolesnika koji su predviđeni za liječenje u ispitivanju (intent to treat analysis), u kojoj su bolesnici s nedostajućim vrijednostima smatrani kao virološki neuspjeh
English: Anaemia, leucopenia, neutropenia, lymphadenopathy
Croatian: Anemija, leukopenija, neutropenija, limfadenopatija
English: The in vitro antiviral activity of lopinavir against laboratory and clinical HIV strains was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively.
Croatian: Antivirusna aktivnost in vitro Antivirusna aktivnost lopinavira na laboratorijske i kliničke sojeve HIV-a ispitivana je na akutno inficiranim limfoblastičnim staničnim lozama i limfocitima iz periferne krvi in vitro.
English: The active substances are lopinavir and ritonavir.
Croatian: Djelatne tvari su lopinavir i ritonavir.
English: Other side effects that have been reported with Kaletra:
Croatian: Druge nuspojave koje su zabilježene kod liječenja lijekom Kaletra:
English: Rilpivirine:
Croatian: Rilpivirin:
English: Using the 2 ml oral dosing syringe for doses up to 2 ml
Croatian: Korištenje štrcaljke od 2 ml za primjenu kroz usta doza do 2 ml
English: • 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;
Croatian: • upala početnog dijela tankog crijeva koje se nastavlja odmah na želudac, rana ili čir probavnog trakta, krvarenje iz probavnog trakta ili rektuma (završni dio debelog crijeva);
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have 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 and triamcinolone.
Croatian: Sistemski učinci kortikosteroida, uključujući Cushingov sindrom i supresiju adrenalne funkcije, prijavljeni su u bolesnika koji su primali ritonavir i inhalacijski ili intranazalno primijenjen flutikazonpropionat; ti su učinci mogući i pri primjeni drugih kortikosteroida koji se metaboliziraju putem P450 3A, npr. pri primjeni budezonida i triamcinolona.
English: If a child is unable to reliably swallow a Kaletra tablet, Kaletra oral solution formulation should be prescribed.
Croatian: Djeci koja nisu u stanju progutati tabletu, mora se propisati Kaletra oralna otopina.
English: Smoking cessation aids Bupropion
Croatian: Pripravci za odvikavanje od pušenja Bupropion
English: Multipack: 360 (3 bottles of 120) film-coated tablets 3 month pack
Croatian: Višestruko pakiranje: 360 (3 boce po 120) filmom obloženih tableta Pakiranje za 3 mjeseca
English: Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Croatian: Kaletra (80 mg + 20 mg) / ml oralna otopina (lopinavir + ritonavir)
English: Concomitant Therapy: Efavirenz or Nevirapine
Croatian: Istodobna terapija: efavirenz ili nevirapin
English: Concomitant administration of Kaletra and amiodarone or dronedarone is contraindicated (see section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased.
Croatian: Istodobna primjena lijeka Kaletra i amiodarona ili dronedarona je kontraindicirana (vidjeti dio 4.3) jer može doći do povišenog rizika od aritmija ili ostalih ozbiljnih nuspojava.
English: 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.
Croatian: Izolirani sojevi zadržali su osjetljivost na tipranavir s medijanom porasta IC50 od 1,9 puta u sojeva izoliranih na početku i 1,8 puta u sojeva izoliranih kod ponovnog porasta broja virusa u odnosu na divlje sojeve virusa.
English: ≥ 0.8 to < 1.2
Croatian: ≥ 0,8 do < 1,2
English: Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia (see section 4.5).
Croatian: Povišena koncentracija derivata ergota u plazmi koja vodi do akutne ergotne toksičnosti, uključujući vazospazam i ishemiju (vidjeti dio 4.5).
English: • erectile dysfunction medicines (e.g. sildenafil and tadalafil);
Croatian: • lijekovi za liječenje erektilne disfunkcije (npr. sildenafil i tadalafil);
English: Repeat-dose toxicity studies in rodents and dogs identified major target organs as the liver, kidney, thyroid, spleen and circulating red blood cells.
Croatian: Ispitivanjem toksičnosti višekratnih doza u glodavaca i pasa pokazalo se da su glavni ciljni organi jetra, bubrezi, štitnjača, slezena i eritrociti u cirkulaciji.
English: Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Croatian: Budući da je izlučivanje lopinavira i ritonavira kroz bubrege zanemarivo, u bolesnika s oštećenjem bubrega ne očekuje se povišenje koncentracije lijeka u plazmi.
English: Antiretroviral Agents
Croatian: Antiretrovirotici
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 µg•h/ml.
Croatian: lopinavira je tijekom 24 satnog doziranja prosječno bila 206,5 ± 89,7 μg·h/ml.
English: • eye disorder, abnormal vision;
Croatian: • poremećaj oka, poremećen vid;
English: • anti-gout medicines (e.g. colchicine).
Croatian: • lijekovi za liječenje gihta (npr. kolhicin).
English: Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Croatian: dermatitis/osip uključujući ekcem i seboroični dermatitis, noćno znojenje, svrbež
English: 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).
Croatian: Istodobna primjena lijeka Kaletra i ergot alkaloida je kontraindicirana jer može dovesti do akutne ergotne toksičnosti, uključujući vazospazam i ishemiju (vidjeti dio 4.3).
English: Uncommon Rhabdomyolysis, osteonecrosis
Croatian: Manje često Rabdomioliza, osteonekroza
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Croatian: KG, Knollstrasse, 67061 Ludwigshafen, Njemačka
English: Patients without prior antiretroviral therapy
Croatian: Bolesnici bez prethodne terapije antiretrovirusnim lijekovima
English: − If you notice you miss a dose by more than 12 hours after your normal dosing time, do not take the missed dose.
Croatian: Ako primijetite da ste propustili uzeti jednu dozu, a prošlo je više od 12 sati od vremena kada ste trebali uzeti lijek, nemojte uzeti propuštenu dozu.
English: Other medicinal products
Croatian: Ostali lijekovi
English: Increased plasma concentrations of astemizole and terfenadine.
Croatian: Povišena koncentracija astemizola i terfenadina u plazmi.
English: • inability to control your bowels;
Croatian: • nemogućnost kontrole crijeva;
English: 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
Croatian: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Ujedinjeno Kraljevstvo AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Nizozemska
English: Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Croatian: Budući da je veći dio lijeka Kaletra vezan za proteine, dijaliza vjerojatno ne bi znatnije pomogla u uklanjanju djelatne tvari.
English: Hypertension Uncommon Deep vein thrombosis
Croatian: Hipertenzija Manje često Duboka venska tromboza
English: 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.
Croatian: Hipromeloza, titanijev dioksid, makrogol tip 400 (polietilenglikol 400), hidroksipropilceluloza, talk, bezvodni, koloidni silicijev dioksid, makrogol tip 3350 (polietilenglikol 3350), žuti željezov oksid (E172), polisorbat 80.
English: Therefore, if co-administration of delamanid with lopinavir/ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.5 and refer to the delamanid SmPC).
Croatian: Stoga, ukoliko se istodobna primjena delamanida i lopinavira/ritonavira smatra nužnom, preporučuje se vrlo učestalo praćenje EKG-a bolesnika tijekom cijelog razdoblja liječenja delamanidom (vidjeti dio 4.5 i sažetak opisa svojstava lijeka za delamanid).
English: Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5).
Croatian: Moguće ozbiljne i/ili po život opasne reakcije u bolesnika s oštećenjem funkcije bubrega i/ili jetre (vidjeti dijelove 4.4 i 4.5).
English: Lopinavir is extensively metabolised by the hepatic cytochrome P450 system, almost exclusively by isozyme CYP3A.
Croatian: Lopinavir se ekstenzivno metabolizira sustavom citokroma P450 iz jetre i to gotovo isključivo putem izoenzima CYP3A.
English: Paediatric dosing guidelines without concomitant efavirenz or nevirapine*
Croatian: Smjernice za pedijatrijsko doziranje bez istodobne primjene efavirenza i nevirapina*
English: − If you notice you miss a dose by more than 6 hours after your normal dosing time, do not take the missed dose.
Croatian: Ako primijetite da ste propustili uzeti jednu dozu, a prošlo je više od 6 sati od vremena kada ste trebali uzeti lijek, nemojte uzeti propuštenu dozu.
English: Rationale
Croatian: Obrazloženje
English: Table 7
Croatian: Tablica 7