natgillin/translations-raw huggingface dataset:
Do not combine Darunavir Krka with products that contain St John's wort (Hypericum perforatum).
Nemojte kombinirati Darunavir Krka s pripravcima koji sadrže gospinu travu (Hypericum perforatum).
Darunavir is not recommended for use in paediatric patients below 3 years of age or less than 15 kg body weight (see sections 4.2 and 5.3).
Darunavir se ne preporučuje u pedijatrijskih bolesnika mlađih od 3 godine starosti ili manje od 15 kg tjelesne težine (vidjeti dijelove 4.2 i 5.3).
Titanium dioxide (E171) Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
poli(vinilni alkohol) makrogol titanijev dioksid (E171) talk (E553b) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
Stoga, učinci na istodobno primijenjene lijekove mogu biti podcijenjeni pa može biti indicirano kliničko praćenje sigurnosti.
Metabolism and nutrition disorders common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Poremećaji metabolizma i prehrane često anoreksija, dijabetes melitus, hiperkolesterolemija, hipertrigliceridemija, hiperlipidemija
Patients received a weight-based twice daily treatment regimen, patients weighing 10 kg to < 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Bolesnici su primili režim liječenja dvaput na dan ovisno o tjelesnoj težini, pri čemu su bolesnici tjelesne težine 10 kg do < 15 kg primili darunavir/ritonavir 25/3 mg/kg dvaput na dan, dok su bolesnici tjelesne težine 15 kg do < 20 kg primili darunavir/ritonavir 375/50 mg dvaput na dan.
Medicinal products that affect darunavir exposure (cobicistat as pharmacoenhancer)
Lijekovi koji utječu na izloženost darunaviru (kobicistat kao farmakokinetički pojačivač)
Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Ne-nukleo(z/t)idni inhibitori reverzne transkriptaze (NNRTI) Efavirenz
The maraviroc dose should be 150 mg twice daily when co-administered with boosted darunavir.
Doza maraviroka mora biti 150 mg dvaput na dan kada se primjenjuje istodobno s pojačanim darunavirom.
Efavirenz in combination with darunavir /ritonavir 800/100 mg once daily may result in sub-optimal darunavir Cmin.
Efavirenz u kombinaciji s darunavirom/ritonavirom od 800/100 mg jedanput na dan može rezultirati suboptimalnim vrijednostima darunavira Cmin.
ANTIMALARIALS Artemether/Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether AUC ↓ 16% artemether Cmin ↔ artemether Cmax ↓ 18% dihydroartemisinin AUC ↓ 18% dihydroartemisinin Cmin ↔ dihydroartemisinin Cmax ↓ 18% lumefantrine AUC ↑ 175% lumefantrine Cmin ↑ 126% lumefantrine Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
ANTIMALARICI Artemeter/Lumefantrin 80/480 mg, 6 doza u 0., 8., 24., 36., 48. i 60. satu artemeter AUC ↓ 16% artemeter Cmin ↔ artemeter Cmax ↓ 18% dihidroartemisinin AUC ↓ 18% dihidroartemisinin Cmin ↔ dihidroartemisinin Cmax ↓ 18% lumefantrin AUC ↑ 175% lumefantrin Cmin ↑ 126% lumefantrin Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
100 milligram ritonavir oral solution: 80 milligram per milliliter
100 miligrama oralna otopina ritonavira: 80 miligrama po mililitru
Cardiac disorders uncommon myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia rare acute myocardial infarction, sinus bradycardia, palpitations
Srčani poremećaji manje često infarkt miokarda, angina pektoris, produljeni QT interval na elektrokardiogramu, tahikardija rijetko akutni infarkt miokarda, sinusna bradikardija, palpitacije
The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted darunavir.
Metabolizam alfentanila posredovan je putem CYP3A i kao takav može biti inhibiran pojačanim darunavirom.
Darunavir Krka is not a cure for HIV infection.
Darunavir Krka neće izliječiti infekciju HIV-om.
Iron oxide, yellow (E172) - only for 400 mg film-coated tablets Iron oxide, red (E172)
talk (E553b) željezov oksid, žuti (E172) - samo u 400 mg filmom obloženim tabletama željezov oksid, crveni (E172)
Tenofovir alafenamide ↔ Tenofovir ↑
Emtricitabin/tenofoviralafenamid Tenofoviralafenamid ↔ Tenofovir ↑
Darunavir and cobicistat are metabolised by CYP3A, and co-administration with CYP3A inducers may therefore result in subtherapeutic plasma exposure to darunavir.
Darunavir i kobicistat se metaboliziraju putem enzima CYP3A, stoga istodobna primjena s CYP3A induktorima može rezultirati supterapijskim izloženostima darunaviru u plazmi.
No special precautions or dose adjustments for darunavir/ritonavir are required in patients with renal impairment.
Nisu potrebne posebne mjere opreza ili prilagodbe doze za darunavir/ritonavir u bolesnika s oštećenjem funkcije bubrega.
Postpartum (6-12 weeks)
Postpartalno razdoblje (6-12 tjedana)
However, dizziness has been reported in some patients during treatment with regimens containing darunavir co-administered with low dose ritonavir and should be borne in mind when considering a patient's ability to drive or operate machinery (see section 4.8).
Međutim, prijavljena je omaglica u nekih bolesnika tijekom liječenja režimima koji su sadržavali darunavir primijenjen istodobno s niskom dozom ritonavira, što se mora imati na umu kada se procjenjuje bolesnikova sposobnost vožnje ili upravljanja strojevima (vidjeti dio 4.8).
One ritonavira dose is between 15 and 30 kilograms 600 milligram
Jedna doza darunavira je Jedna doza ritonavira a je između 15 i 30 kilograma 600 miligrama
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using darunavir/ritonavir, interruption or discontinuation of treatment should be considered promptly.
Ako postoje dokazi o novoj ili pogoršanju disfunkcije jetre (uključujući klinički značajno povišenje enzima jetre i/ili simptomi poput umora, anoreksije, mučnine, žutice, tamne mokraće, osjetljivosti jetre, hepatomegalije) u bolesnika koji uzimaju darunavir/ritonavir mora se odmah razmotriti privremeni ili trajni prekid liječenja.
HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔*
LIJEKOVI KOJI DJELUJU NA HIV Inhibitori prijenosa lanca integraze Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔*
Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of darunavir used in combination with cobicistat or low dose ritonavir treatment.
Mora se razmotriti pojačano praćenje AST/ALT u bolesnika s podležećim kroničnim hepatitisom, cirozom ili u bolesnika koji su prije liječenja imali povišenja transaminaza, posebno tijekom prvih nekoliko mjeseci liječenja darunavirom koji se uzima u kombinaciji s kobicistatom ili niskom dozom ritonavira.
It is not recommended to alter the dose of cobicistat or ritonavir.
Ne preporučuje se mijenjati dozu kobicistata ili ritonavira.
Adverse reactions observed with darunavir/cobicistat in adult patients
Nuspojave zabilježene s darunavirom/kobicistatom u odraslih bolesnika
Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when darunavir coadministered with low dose ritonavir is given in combination with efavirenz.
Kliničko praćenje toksičnosti na središnji živčani sustav povezano s povećanom izloženosti efavirenzu može biti indicirano kada je darunavir istodobno primijenjen s niskom dozom ritonavira i dan u kombinaciji s efavirenzom.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartrozu u bolesnika s hemofilijom tipa
In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
Pri odlučivanju o uvođenju liječenja darunavirom u bolesnika prethodno liječenih ART-om, u primjeni darunavira treba se rukovoditi rezultatima genotipizacije (vidjeti dijelove 4.2, 4.3, 4.4 i 5.1).
If antidepressants are co-administered with darunavir with low dose ritonavir, the recommended approach is a dose titration of the antidepressant based on a clinical assessment of antidepressant response.
Ako se antidepresivi primjenjuju uz darunavir s niskom dozom ritonavira, preporučeni pristup je titracija doze antidepresiva temeljeno na kliničkoj procjeni odgovora na antidepresiv.
No treatment related mortalities were noted in juvenile rats dosed at 1,000 mg/kg darunavir (single dose) on day 26 of age or at 500 mg/kg (repeated dose) from day 23 to 50 of age, and the exposures and toxicity profile were comparable to those observed in adult rats.
Nije bila zabilježena smrtnost uslijed liječenja mladih štakora pri dozi od 1000 mg/kg darunavira (jednokratna doza) na 26. dan starosti ili pri dozama od 500 mg/kg (ponovljene doze) od 23. do 50. dana starosti.
Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
- kortikosteroidi uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
U 192 tjednoj analizi nije bilo novih sigurnosnih nalaza u prethodno neliječenih ispitanika, a u kojih je srednja vrijednost trajanja liječenja darunavirom/ritonavirom od 800/100 mg jednaput na dan bila 162,5 tjedana.
The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by darunavir co-administered with low dose ritonavir.
Metabolizam alfentanila posredovan je putem CYP3A, i kao takav može biti inhibiran darunavirom istodobno primijenjenim s niskom dozom ritonavira.
In addition, pharmacokinetic modeling and simulation of darunavir exposures in paediatric patients across the ages of 3 to < 18 years confirmed the darunavir exposures as observed in the clinical studies and allowed the identification of weight-based darunavir/ritonavir once daily dosing regimens for paediatric patients weighing at least 15 kg that are either ART-naïve or treatment-experienced paediatric patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Dodatno, farmakokinetičko modeliranje i simulacija izloženosti darunaviru u pedijatrijskih bolesnika u rasponu dobi 3 do < 18 godina potvrdilo je izloženosti darunaviru kako je uočeno u kliničkim ispitivanjima, te je identificiralo režim doziranja za darunavir/ritonavir temeljen na težini jednaput na dan za pedijatrijske bolesnike težine najmanje 15 kg koji prethodno nisu liječeni ART-om ili za prethodno liječene pedijatrijske bolesnike koji nemaju DRV-RAM* a imaju plazmatsku HIV-1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
Rilpivirine 150 mg once daily rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
Rilpivirin 150 mg jedanput na dan rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
150 mg dvaput na dan maravirok AUC ↑ 305% maravirok Cmin ND maravirok Cmax ↑ 129% koncentracije darunavira, ritonavira bile su sukladne s podacima u anamnezi.
Darunavir boosted with cobicistat is more sensitive to CYP3A induction than ritonavir-boosted darunavir: co-administration of darunavir/cobicistat with medicinal products that are strong inducers of CYP3A (e.g. St John's wort, rifampicin, carbamazepine, phenobarbital, and phenytoin) is contraindicated (see section 4.3).
Darunavir pojačan s kobicistatom je osjetljiviji na CYP3A indukciju u odnosu na darunavir pojačan ritonavirom: kontraindicirana je istodobna primjena darunavira/kobicistata s lijekovima snažnim induktorima CYP3A (npr. gospina trava, rifampicin, karbamazepin, fenobarbital i fenitoin) (vidjeti dio 4.3).
Ear and labyrinth disorders uncommon vertigo
Poremećaji uha i labirinta manje često vertigo
Co-administration of darunavir with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Istodobna primjena darunavira s niskom dozom ritonavira s lijekovima čiji klirens u velikoj mjeri ovisi o CYP3A i čije su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima.
In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatmentnaïve subjects was similar to that seen with darunavir/ritonavir 600/100 mg twice daily in treatmentexperienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
U 96 tjednoj analizi, sigurnosni profil primjene darunavira/ritonavira od 800/100 mg jedanput na dan u prethodno neliječenih ispitanika bio je sličan profilu primjene darunavira/ritonavira od 600/100 mg dvaput na dan u prethodno liječenih ispitanika, osim mučnine koja je češće opažena u prethodno neliječenih ispitanika.
Immune reconstitution inflammatory syndrome
Upalni sindrom imunološke rekonstitucije
Tenofovir disoproxil 245 mg once daily tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir from effect on MDR-1 transport in the renal tubules)
Tenofovir dizoproksil 245 mg jedanput na dan tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovira zbog učinka na transport putem MDR-1 u bubrežnim tubulima)
The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with darunavir/ritonavir (600/100 mg twice daily) with an about 10fold increase in the daily exposure to the active metabolite 25-O-desacetylrifabutin.
Ispitivanje interakcije pokazalo je usporedivu dnevnu sistemsku izloženost za rifabutin između liječenja s 300 mg jedanput na dan samostalno i 150 mg jedanput svaki drugi dan u kombinaciji s darunavirom/ritonavirom (600/100 mg dvaput na dan) uz oko 10 puta veću dnevnu izloženost aktivnom metabolitu 25-O-desacetilrifabutinu.
During the second trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin were 50%, 63%, and 83% lower, respectively, as compared with postpartum.
Tijekom drugog tromjesečja trudnoće, Cmax, AUC24h, i Cmin kobicistata bile su 50%, 63% odnosno 83% niže u usporedbi s postpartalnim razdobljem.
The combination of rifapentine and boosted darunavir is not recommended.
Kombinacija rifapentina i pojačanog darunavira se ne preporučuje.
Systemic dexamethasone should be used with caution when combined with boosted darunavir.
Sistemski deksametazon mora se primijeniti s oprezom kada se kombinira s pojačanim darunavirom.
Clinical monitoring is recommended when co-administering darunavir with these sedatives/hypnotics and a lower dose of the sedatives/hypnotics should be considered.
Preporučuje se kliničko praćenje kada se istodobno primjenjuje darunavir s tim sedativima/hipnoticima i u obzir treba uzeti nižu dozu sedativa/hipnotika.
Amitriptyline Desipramine Imipramine Nortriptyline Trazodone paroxetine AUC ↓ 39% paroxetine Cmin ↓ 37% paroxetine Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertraline AUC ↓ 49% sertraline Cmin ↓ 49% sertraline Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
Amitriptilin paroksetin AUC ↓ 39% paroksetin Cmin ↓ 37% paroksetin Cmax ↓ 36% darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔ sertralin AUC ↓ 49% sertralin Cmin ↓ 49% sertralin Cmax ↓ 44% darunavir AUC ↔ darunavir Cmin ↓ 6% darunavir Cmax ↔
The pharmacokinetic enhancing effect of pharmacokinetic enhancer other than ritonavir on darunavir was evaluated in a Phase I study in healthy subjects that were administered darunavir 800 mg with ritonavir at 100 mg or other phrmacokinetic enhancer once daily.
Učinak farmakokinetičkog pojačivanja farmakokinetičkog pojačivača osim ritonavira na darunavir bio je procijenjen u ispitivanju faze I u zdravih dobrovoljaca kojima je darunavir od 800 mg bio primijenjen bilo s ritonavirom od 100 mg ili drugim farmakokinetičkim pojačivačem jedanput na dan.
Reproductive system and breast disorders uncommon erectile dysfunction, gynaecomastia
Poremećaji reproduktivnog sustava i dojki manje često erektilna disfunkcija, ginekomastija
Darunavir Krka contains the active substance darunavir.
Darunavir Krka sadrži djelatnu tvar darunavir.
OTHER LIPID MODIFYING AGENTS Lomitapide
DRUGI LIJEKOVI KOJI MODIFICIRAJU LIPIDE Lomitapid
When used in combination with darunavir co-administered with low dose ritonavir, dose adjustment of indinavir from 800 mg twice daily to 600 mg twice daily may be warranted in case of intolerance.
Kada se darunavir primijeni istodobno s niskom dozom ritonavira u kombinaciji s indinavirom, može biti potrebna prilagodba doze indinavira s 800 mg dvaput na dan na 600 mg dvaput na dan u slučaju nepodnošljivosti.
CYP3A inducers that are contraindicated include rifampicin, St John's wort and lopinavir.
Kontrainidicirani CYP3A induktori uključuju npr. rifampicin, gospinu travu i lopinavir.
Common side effects (may affect up to 1 in 10 people) vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.
Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - povraćanje, mučnina, bol u trbuhu ili nadutost trbuha, probavne tegobe, vjetrovi - glavobolja, umor, omaglica, omamljenost, utrnulost, trnci ili bolovi u rukama ili stopalima, gubitak snage, poteškoće s usnivanjem.
Clinical monitoring is recommended when co-administering boosted darunavir with these sedatives/hypnotics and a lower dose of the sedatives/hypnotics should be considered.
Preporučuje se kliničko praćenje kada se istodobno primjenjuje pojačan darunavir s tim sedativima/hipnoticima i u obzir treba uzeti nižu dozu sedativa/hipnotika.
Coadministration with boosted darunavir may cause a large increase in the concentration of these medicines.
Istodobna primjena s pojačanim darunavirom može izazvati velik porast koncentracije tih lijekova.
Medicinal products that affect darunavir exposure (ritonavir as pharmacoenhancer)
Lijekovi koji utječu na izloženost darunaviru (uz ritonavir kao farmakokinetički pojačivač)
HIV Protease inhibitors (PIs) - with co-administration of low dose ritonavir Lopinavir/ritonavir
Inhibitori Proteaze (IP) HIV-a - uz istodobnu primjenu niske doze ritonavira Lopinavir/ritonavir
Darunavir Krka cannot work properly without ritonavir and food.
Darunavir Krka ne može pravilno djelovati bez ritonavira i hrane.
However, dizziness has been reported in some patients during treatment with regimens containing darunavir co-administered with cobicistat or low dose ritonavir and should be borne in mind when considering a patient's ability to drive or operate machinery (see section 4.8).
Međutim, prijavljena je omaglica u nekih bolesnika tijekom liječenja režimima koji su sadržavali darunavir primijenjen istodobno s kobicistatom ili niskom dozom ritonavira, što se mora imati na umu kada se procjenjuje bolesnikova sposobnost vožnje ili upravljanja strojevima (vidjeti dio 4.8).
No interaction studies presented in the table have been performed with darunavir boosted with cobicistat.
Ispitivanja interakcija, navedena u tablici niže, nisu bila provedena s darunavirom pojačanim s kobicistatom.
Darunavir given with low dose ritonavir may be considered as an alternative.
Darunavir koji se daje s niskom dozom ritonavira može se uzeti u obzir kao zamjena.
Darunavir Krka600 mg tablets can be used to construct the twice daily 600 mg regimen.
Darunavir Krka od 600 mg tablete mogu se primijeniti za dostizanje režima doziranja od 600 mg dvaput na dan.
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
ANTIKOAGULANSI/INHIBITOR AGREGACIJE TROMOBOCITA
BOX
KUTIJA
During the third trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin, were 27%, 49%, and 83% lower, respectively, as compared with postpartum.
Tijekom trećeg tromjesečja trudnoće Cmax, AUC24h, i Cmin kobicistata bile su 27%, 49% odnosno 83% niže u usporedbi s postpartalnim razdobljem.
Nervous system disorders common headache, peripheral neuropathy, dizziness uncommon lethargy, paraesthesia, hypoaesthesia, dysgeusia, disturbance in attention, memory impairment, somnolence rare syncope, convulsion, ageusia, sleep phase rhythm disturbance
Poremećaji živčanog sustava često glavobolja, periferna neuropatija, omaglica manje često letargija, parestezija, hipoestezija, disgeuzija, poremećaj pažnje, oštećenje pamćenja, somnolencija rijetko sinkopa, konvulzija, ageuzija, poremećaj ritma faza spavanja
The concomitant use with darunavir and low dose ritonavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Istodobna primjena s darunavirom i niskom dozom ritonavira može zahtijevati snižavanje doze alfentanila i zahtjeva praćenje rizika na produljenu ili odgođenu respiratornu depresiju.
Darunavir Krka is not for use in children younger than 3 years of age or weighing less than 15 kilograms.
Darunavir Krka nije namijenjen za primjenu u djece mlađe od 3 godine ili tjelesne težine manje od 15 kilograma.
Darunavir Krka cannot work properly without ritonavir.
Darunavir Krka ne može pravilno djelovati bez ritonavira.
Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Analiza populacijskih farmakokinetičkih podataka u HIV-om inficiranih bolesnika (n=12, dob ≥ 65) pokazala je da farmakokinetika darunavira nije bitno različita u rasponu dobi (18 do 75 godina) (vidjeti dio 4.4).
Other severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).
Ostale teške nuspojave bile su šećerna bolest (često) i upala gušterače (manje često).
Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine
Nukleo(z/t)idni inhibitori reverzne transkriptaze (NRTI) Didanozin
Take two 400 milligram tablets at the same time or one 800 miligram tablet, once a day, every day.
- Uzimite dvije tablete od 400 miligrama u isto vrijeme ili jednu tabletu od
bottle of 30 film-coated tablets) and 90 film-coated tablets (3 bottles of 30 film-coated tablets) in a box.
30 filmom obloženih tableta (1 bočica s 30 filmom obloženih tableta) i 90 filmom obloženih tableta (3 bočice s 30 filmom obloženih tableta) u kutiji.
Caution should be exercised when clarithromycin is combined with boosted darunavir.
Nužan je oprez kada se klaritromicin kombinira s pojačanim darunavirom.
The pharmacokinetic properties of darunavir, co-administered with ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients.
Farmakokinetička svojstva darunavira primijenjenog istodobno s ritonavirom, ispitivana su u zdravih odraslih dobrovoljaca i u bolesnika inficiranih s HIV-1.