natgillin/translations-raw huggingface dataset:
Cobicistat is 97 to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Kobicistat je 97 do 98% vezan na proteine plazme u ljudi, a srednja vrijednost omjera koncentracije lijeka između plazme i krvi je bila otprilike 2.
Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes REZOLSTA should not be used in paediatric patients below 3 years of age.
S obzirom na nesigurnost vezanu uz poznavanje brzine razvoja ljudske krvno-moždane barijere i jetrenih enzima, REZOLSTA se ne smije primjenjivati pedijatrijskim bolesnicima mlađima od 3 godine starosti.
REZOLSTA should be used with caution in patients with a known sulphonamide allergy.
REZOLSTA se mora primjenjivati s oprezom kod bolesnika s poznatom alergijom na sulfonamide.
Treatment with REZOLSTA will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection.
Vaš imunološki sustav (prirodni obrambeni mehanizam Vašeg tijela) i smanjiti rizik od razvoja bolesti koje su vezane uz HIV infekciju, ali REZOLSTA neće izliječiti HIV infekciju.
Third trimester of pregnancy N=6
Treće tromjesečje trudnoće (n=6)
In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
U slučaju istodobne antivirusne terapije za hepatitis B ili C, potrebno je slijediti relevantne informacije o lijeku koji postoje za te lijekove.
- Clonazepam (to prevent seizures).
- klonazepam (za sprječavanje napadaja).
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately so you can be given the necessary treatment.
Ako primjetite bilo koji simptom infekcije ili drugi simptom poput mišićne slabosti, slabosti koja počinje u šakama i stopalima te se širi gore prema trupu tijela, lupanja srca, tremora ili hiperaktivnosti, molimo Vas odmah obavijestite liječnika i kako bi Vam pružio potrebno liječenje.
The clinical relevance of this increase is unknown, therefore, darunavir/ritonavir should be used with caution.
Klinički značaj ovog povišenja nije poznat, stoga se darunavir/ritonavir moraju primjenjivati s oprezom.
Therapy should be initiated by a healthcare provider experienced in the management of HIV infection.
Terapiju mora započeti liječnik s iskustvom u liječenju HIV infekcije.
TMC114FD2HTX3001 (darunavir/cobicistat arm)
TMC114FD2HTX3001 (skupina koja je primala darunavir/kobicistat)
Ethinylestradiol (0.02 mg once daily)
Etinilestradiol (0,02 mg jedanput na dan)
Clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.
Preporučuje se kliničko praćenje, jer će se za neke bolesnike možda morati prilagoditi terapija održavanja.
The median terminal plasma half-life of cobicistat following administration of REZOLSTA is approximately 3-4 hours.
Medijan terminalnog poluvijeka kobicistata u plazmi nakon primjene lijeka REZOLSTA iznosi oko 3-4 sata.
Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV infected females compared to males.
Analiza populacijske farmakokinetike pokazala je neznatno višu izloženost darunaviru (16,8%) kod HIV-om inficiranih žena u usporedbi s muškarcima.
If you notice within 12 hours, you must take the tablet immediately.
Ako primijetite da niste uzeli lijek unutar 12 sati, tabletu morate uzeti odmah.
White, high density polyethylene (HDPE) bottle containing 30 tablets, fitted with polypropylene (PP) child resistant closure with induction seal.
Bijela boca od polietilena visoke gustoće (HDPE) koja sadrži 30 tableta, opremljena polipropilenskim (PP) zatvaračem sigurnim za djecu sa zalijepljenom zaštitnom folijom.
REZOLSTA must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting.
REZOLSTA se ne smije uzimati s drugim antivirusnim lijekom koji sadrži pojačivač ili drugim antivirotikom kojemu je potrebno pojačanje.
The type of food does not affect exposure to REZOLSTA.
Vrsta hrane ne utječe na izloženost lijeku REZOLSTA.
Do not take REZOLSTA - if you are allergic to darunavir, cobicistat or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek REZOLSTA - ako ste alergični na darunavir, kobicistat ili neki drugi sastojak ovog lijeka (naveden u dijelu
*study was done with tenofovir disoproxil fumarate
*ispitivanje je provođeno s tenofovirdizoproksilfumaratom
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
Based on animal studies, no effect on mating or fertility is expected with REZOLSTA.
Temeljeno na ispitivanjima na životinjama, ne očekuje se učinak lijeka REZOLSTA na parenje ili plodnost.
Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
Nakon peroralne primjene lijeka REZOLSTA u zdravih dobrovoljaca, maksimalna koncentracija u plazmi bila je zapažena 2 do 5 sati nakon uzimanja doze.
In the Phase III single-arm trial (GS-US-216-130), a decrease in eGFRCG was noted at week 2, which remained stable through week 48.
U ispitivanju faze III s jednom skupinom (GS-US-216-130), zabilježen je pad eGFRCG u 2. tjednu, koji je ostao stabilan do 48. tjedna.
People taking REZOLSTA may develop a skin rash.
U osoba koje uzimaju lijek REZOLSTA može se razviti kožni osip.
Data based on analyses at week 96
Podaci dobiveni analizama u 96. tjednu
Iron oxide black
Željezov oksid, crni
The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with REZOLSTA should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Donja tablica primjera interakcija s drugim lijekovima nije sveobuhvatna, stoga je potrebno proučiti informacije o lijeku za svaki lijek koji se primjenjuje zajedno s lijekom REZOLSTA, kako bi se informirali o metabolizmu lijeka, putovima interakcije, potencijalnim rizicima i specifičnim aktivnostima koje treba poduzeti s obzirom na istodobnu primjenu.
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 REZOLSTA treatment.
Mora se razmotriti pojačano praćenje AST/ALT kod bolesnika s podležećim kroničnim hepatitisom, cirozom ili kod bolesnika koji su prije liječenja imali povišene vrijednosti transaminaza, posebno tijekom prvih nekoliko mjeseci liječenja lijekom REZOLSTA.
Rare drug reaction with eosinophilia and systemic symptoms*
urtikarija rijetko reakcija na lijek s eozinofilijom i sistemskim simptomima*
Based on the different elimination pathways of the other NRTIs (i.e. emtricitabine, lamivudine, stavudine and zidovudine) that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP, no interactions are expected for these medicinal compounds and REZOLSTA.
Na temelju različitih puteva eliminacije drugih NRTI-ova, (tj. emtricitabina, lamivudina, stavudina i zidovudina) koji se primarno izlučuju putem bubrega, te abakavira čiji metabolizam nije posredovan CYP-om, ne očekuju se interakcije ovih lijekova i lijeka REZOLSTA.
Darunavir, cobicistat, or the combination of both have not been studied in patients receiving dialysis, and therefore no recommendation can be made for these patients (see section 5.2).
Darunavir, kobicistat ili kombinacija navedenih nisu bili ispitivani u bolesnika koji su na dijalizi i stoga se ne mogu dati preporuke za te bolesnike (vidjeti dio 5.2).
HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors
ANTIVIRUSNI LIJEKOVI DIREKTNOG DJELOVANJA NA VIRUS HEPATITISA C (HCV) NS3-4A inhibitori
In the table below it is specified when recommendations for REZOLSTA differ from those for darunavir boosted with low dose ritonavir.
U tablici ispod specifično je navedeno kada se preporuke za lijek REZOLSTA razlikuju od onih za darunavir pojačan s niskom dozom ritonavira.
C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
C-darunavira s ritonavirom, približno 79,5% odnosno 13,9%
Interaction not studied with any of the components of REZOLSTA.
Nije ispitana interakcija niti s jednom komponentom lijeka REZOLSTA.
- Take your other HIV medicines used in combination with REZOLSTA as recommended by your doctor.
- Ostale lijekove protiv HIV-a koje primjenjujete u kombinaciji s lijekom REZOLSTA uzimajte prema preporuci Vašeg liječnika.
Treatment with REZOLSTA during pregnancy results in low darunavir exposure.
Liječenje lijekom REZOLSTA tijekom trudnoće rezultira niskom izloženošću darunaviru.
DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
DRESS (osip izazvan lijekom s eozinofilijom i sistemskim simptomima) i Stevens-Johnsonov sindrom bili su rijetko (< 0,1%) prijavljivani, a tijekom postmarketinškog iskustva prijavljene su toksična epidermalna nekroliza i akutna generalizirana egzantematozna pustuloza.
These decreases in eGFRCG were reversible after cobicistat was discontinued and did not affect the actual glomerular filtration rate, as determined by the clearance of probe drug iohexol.
Ova sniženja eGFRCG bila su reverzibilna nakon prestanka uzimanja kobicistata i nisu utjecala na stvarnu brzinu glomerularne filtracije, što je određeno klirensom probnog lijeka ioheksola.
The concomitant use with REZOLSTA may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Istodobna primjena s lijekom REZOLSTA može zahtijevati smanjenje doze alfentanila i zahtijeva praćenje rizika produljene ili odgođene respiratorne depresije.
When administration of HMG CoA reductase inhibitors and REZOLSTA is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.
Kada je poželjna primjena inhibitora HMG CoA reduktaze i lijeka REZOLSTA, preporučeno je započeti s najnižom dozom i titrirati ju na višu do željenog kliničkog učinka i pri tom pratiti sigurnost.
There is no specific antidote for overdose with REZOLSTA.
Ne postoji specifičan antidot za predoziranje lijekom REZOLSTA.
Dizziness has been reported in some patients during treatment with regimens containing darunavir administered with cobicistat and should be borne in mind when considering a patient's ability to drive or operate machinery.
Prijavljena je omaglica kod nekih bolesnika tijekom liječenja režimima koji su sadržavali darunavir primijenjen istodobno s kobicistatom, što se mora imati na umu kada se procjenjuje bolesnikova sposobnost vožnje ili upravljanja strojevima.
Dose adjustment for buprenorphine may not be necessary when co-administered with REZOLSTA but a careful clinical monitoring for signs of opiate toxicity is recommended.
Prilagodba doze buprenorfina možda neće biti potrebna kada se primjenjuje istodobno s lijekom REZOLSTA ali se preporučuje pažljivo kliničko praćenje znakova opijatne toksičnosti.
This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids.
Njena pojava može biti vjerojatnija tijekom dugotrajnog liječenjaHIV-a, uz teže oštećenje imunološkog sustava, prekomjernu težinu ili uzimanje alkohola ili drugih lijekova koji ze zovu kortikosteroidi.
During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Tijekom kliničkog razvojnog programa darunavira/ritonavira (N = 3063), teške kožne reakcije, koje mogu biti praćene vrućicom i/ili povišenim transaminazama, bile su prijavljene u 0,4% bolesnika.
If these anti-depressants are to be used with REZOLSTA clinical monitoring is recommended and a dose adjustment of the anti-depressant may be needed.
Ako se ti antidepresivi trebaju uzimati s lijekom REZOLSTA preporučuje se kliničko praćenje i može biti potrebna prilagodba doze antidepresiva.
Clinical monitoring is recommended when co-administering REZOLSTA with beta-blockers and a lower dose of the beta-blocker should be considered.
Preporučuje se kliničko praćenje kada se lijek REZOLSTA istodobno primjenjuje s beta-blokatorima, te se mora uzeti u obzir niža doza beta-blokatora.
With HIV-1 clade Type B
S podtipom HIV-1 Tip B Tip AE Tip C Ostalo
Very common side effects (may affect more than 1 in 10 people) - headache - diarrhoea, nausea.
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - glavobolja - proljev, mučnina.
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).
Prijavljeni su slučajevi osteonekroze, osobito u bolesnika s općepoznatim faktorima rizika, uznapredovalom HIV bolešću ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji (KART).
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
6/l (vidjeti dio 4.1). * DRV-RAM: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Liver problems that may occasionally be severe have been reported.
Prijavljene su tegobe s jetrom, koje ponekad mogu biti teške.
The risk of muscle damage might be increased.
Moguć je povećan rizik od oštećenja mišićnog tkiva.
The plastic bottle comes with a child resistant cap and must be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Plastična boca ima zatvarač siguran za djecu i treba ju otvarati na sljedeći način: Pritisnite plastični zatvarač s navojem prema dolje dok ga okrećete u smjeru suprotnom od kazaljke na satu.
The table below shows the development of HIV-1 protease mutations and loss of susceptibility to HIV PIs in virologic failures at endpoint in the GS-US-216-130, ARTEMIS and ODIN trials.
Tablica ispod pokazuje razvoj mutacija HIV-1 proteaza i gubitak osjetljivosti na HIV PI kod viroloških neuspjeha na ishodu ispitivanja GS-US-216-130, ARTEMIS i ODIN.
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking REZOLSTA.
Preporučuje se pažljivo praćenje bolesnika i prilagodba doze metformina u bolesnika koji uzimaju lijek REZOLSTA.
Your doctor will advise you how to deal with your symptoms or whether REZOLSTA must be stopped.
Liječnik će Vam savjetovati što učiniti vezano uz pojavu simptoma i morate li prestati s uzimanjem lijeka REZOLSTA.
ANAESTHETIC Alfentanil
ANESTETICI Alfentanil
Pack size of one bottle.
Veličina pakiranja: jedna boca po kutiji.
Iron oxide red
Željezov oksid, crveni
If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Ako je primijećeno da je doza propuštena više od 12 sati nakon uobičajenog vremena uzimanja lijeka, propuštena doza se ne smije uzeti, a bolesnik mora ponovno nastaviti s uobičajenim rasporedom doziranja.
REZOLSTA and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Kombinacija lijeka REZOLSTA i artemetera/lumefantrina može se primijeniti bez prilagodbe doze, međutim, zbog povećane izloženosti lumefantrinu, tu kombinaciju se mora primjenjivati s oprezom.
The activity of cobicistat as a pharmacokinetic enhancer to darunavir has been demonstrated in pharmacokinetic trials.
Aktivnost kobicistata kao farmakokinetičkog pojačivača za darunavir dokazana je u farmakokinetičkim ispitivanjima.
Clinical monitoring is recommended when co-administering REZOLSTA with these sedatives/hypnotics and a lower dose of the sedatives/hypnotics should be considered.
Preporučuje se kliničko praćenje kada se REZOLSTA primjenjuje istodobno s tim sedativima/hipnoticima i u obzir se mora uzeti niža doza sedativa/hipnotika.
If REZOLSTA is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Ako se REZOLSTA istodobno primjenjuje s parenteralno primijenjenim midazolamom, primjena bi morala biti u jedinici intenzivnog liječenja ili sličnom odjelu gdje je osigurano pomno kliničko praćenje, te primjereno medicinsko zbrinjavanje u slučaju respiratorne depresije i/ili produljene sedacije.
Human experience of acute overdose with REZOLSTA or darunavir in combination with cobicistat is limited.
Iskustvo akutnog predoziranja kod ljudi lijekom REZOLSTA ili darunavirom u kombinaciji s kobicistatom je ograničeno.
Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
U obje skupine primijenjen je optimizirani osnovni režim koji se sastojao od tenofovirdizoproksilfumarata 300 mg jedanput na dan i emtricitabina 200 mg jedanput na dan.
It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
Preporučeno je da žene zaražene HIV-om ne smiju dojiti dijete zbog mogućnosti prijenosa HIV-a na dijete putem majčina mlijeka te zbog nepoznatih učinaka koje lijek može imati na Vaše dijete.
HIV-RNA
HIV-RNK
Darunavir The absolute oral bioavailability of a single 600 mg dose of darunavir alone is approximately 37%.
Darunavir Apsolutna peroralna bioraspoloživost jednokratne doze od 600 mg samog darunavira je približno 37%.
Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Darunavir nije bio mutagen ili genotoksičan u setu in vitro i in vivo testova uključujući reverznu bakterijsku mutaciju (Ames), kromosomsku aberaciju u ljudskim limfocitima te in vivo mikronukleusni test kod miševa.
Darunavir After a 400/100 mg
Darunavir Nakon doze od 400/100 mg
Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Na temelju normalne aproksimacije razlike u % odgovora Bolesnik koji nije završio ispitivanje ubilježen je kao neuspjeh: bolesnicima koji su prijevremeno prekinuli ispitivanje pripisana je promjena jednaka 0
In rats, ossification changes in the spinal column and sternebrae of fetuses occurred at a dose that produced significant maternal toxicity.
Osifikacijske promjene na kralježnici i sternebri fetusa štakora pojavile su se pri dozi koja je uzrokovala značajnu maternalnu toksičnost.
During the clinical development program (N = 3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Tijekom kliničkog razvojnog programa (N = 3063), hepatitis je prijavljen kod 0,5% bolesnika koji su primali kombiniranu antiretrovirusnu terapiju darunavirom/ritonavirom.
Appropriate laboratory testing should be conducted prior to initiating therapy with REZOLSTA and patients should be monitored during treatment.
Prije početka terapije lijekom REZOLSTA moraju se provesti odgovarajuća laboratorijska ispitivanja, te se bolesnike mora pratiti tijekom liječenja.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
U bolesnica koje koriste estrogene kao hormonsku nadomjesnu terapiju trebaju se klinički pratiti znakovi estrogenske deficijencije.
C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
C-darunavira na zdravim dobrovoljcima pokazalo je da većinu radioaktivnosti u plazmi nakon jednokratne doze od 400/100 mg darunavira s ritonavirom treba pripisati ishodišnoj djelatnoj tvari.
Atorvastatin (10 mg once daily): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Atorvastatin (10 mg jedanput na dan): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin NO
REZOLSTA may have a minor influence on the ability to drive and use machines.
REZOLSTA malo utječe utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Kobicistat inhibira transportere p-glikoprotein (P-gp), BCRP, MATE1, OATP1B1 i OATP1B3.
Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Bolesnici s već postojećom disfunkcijom jetre, uključujući kronični aktivni hepatitis B ili C, imaju povećani rizik za nastanak poremećaja funkcije jetre uključujući teške i potencijalno smrtonosne jetrene nuspojave.
The interaction profile of darunavir depends on whether ritonavir or cobicistat is used as pharmacokinetic enhancer, therefore there may be different recommendations for the use of darunavir with concomitant medicine.
Interakcijski profil darunavira ovisi o tome je li kao farmakokinetički pojačivač korišten ritonavir ili kobicistat, stoga su moguće različite preporuke za uzimanje darunavira s lijekovima u istodobnoj primjeni.
Darunavir Results from a mass balance study with
Darunavir Rezultati ispitivanja masene bilance s
This protein binding is concentration dependent indicative for saturation of binding.
Ovo vezanje na protein je ovisno o koncentraciji i pokazatelj je mogućnosti zasićenja vezanja.
Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Na temelju normalne aproksimacije razlike % odgovora Podtipovi A1, D, F1, G, K, CRF02_AG, CRF12_BF i CRF06_CPX Razlika srednjih vrijednosti
In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see section 4.4).
U kliničkim ispitivanjima s darunavirom/ritonavirom i darunavirom/kobicistatom, osip je bio uglavnom blag do umjeren, a često se javljao unutar prva četiri tjedna liječenja i nestao je s nastavkom doziranja (vidjeti dio 4.4).
REZOLSTA must therefore not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
REZOLSTA se stoga ne smije kombinirati s lijekovima čiji je klirens u velikoj mjeri ovisan o CYP3A i za koje je povećana sistemska izloženost povezana s ozbiljnim i/ili po život opasnim događajima (uski terapijski indeks) (vidjeti dio 4.3).
Increased monitoring for rifabutin associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Potreban je strogi nadzor nuspojava povezanih s rifabutinom, uključujući neutropeniju i uveitis zbog očekivanog povećanja izloženosti rifabutinu.
Paediatric population The pharmacokinetics of REZOLSTA in paediatric patients have not been investigated.
Pedijatrijska populacija Farmakokinetika lijeka REZOLSTA u pedijatrijskih bolesnika nije bila ispitivana.