natgillin/translations-raw huggingface dataset:
absence of prior virologic failure undetectable viral load during the last 6 months under current regimen viral strains not harbouring HIV resistance associated mutations (RAMs) to current regimen.
izostanak prethodnog virološkog neuspjeha nemjerljivo virusno opterećenje tijekom posljednjih 6 mjeseci liječenja trenutnim režimom virusni sojevi koji nisu nositelji mutacija povezanih s rezistencijom HIV-a na trenutni režim liječenja.
REYATAZ 100 mg hard capsules REYATAZ 150 mg hard capsules REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules
REYATAZ 100 mg tvrde kapsule REYATAZ 150 mg tvrde kapsule REYATAZ 200 mg tvrde kapsule REYATAZ 300 mg tvrde kapsule
Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Tablica 7: Ishodi djelotvornosti (pedijatrijski bolesnici u dobi od 6 godina do manje od 18 godina) u 48. tjednu (Ispitivanje AI424-020)
In a multiple-dose study in HIVinfected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
U ispitivanju višestrukih doza u bolesnika zaraženih HIV-om koji su primali doze od 400 mg atazanavira jedanput na dan uz lagani obrok tijekom 12 tjedana, atazanavir je otkriven u cerebrospinalnom likvoru i sjemenu.
100 mg a Ritonavir capsules, tablets or oral solution.
100 mg a Ritonavir kapsule, tablete ili oralna otopina.
Assessment of adverse reactions for REYATAZ is based on safety data from clinical studies and postmarketing experience.
Procjena nuspojava lijeka REYATAZ temelji se na podacima o sigurnosti iz kliničkih ispitivanja i iskustvu nakon stavljanja lijeka u promet.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Tijekom liječenja HIV infekcije moguće je povaćanje tjelesne težine i povišenje razina lipida i glukoze u krvi.
a Atazanavir peak concentrations and AUCs were found to be approximately 26-40% higher during the postpartum period (4-12 weeks) than those observed historically in HIV infected, non-pregnant patients.
Utvrđeno je da su vršne koncentracije i AUC atazanavira približno 26-40% više tijekom postpartalnog razdoblja (412 tjedana) od onih prethodno opaženih u bolesnica zaraženih HIV-om koje nisu bile trudne.
a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
a Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml).
If you forget to take REYATAZ
Ako ste zaboravili uzeti REYATAZ
Metabolism: studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Ispitivanja u ljudi i ispitivanja in vitro na mikrosomima ljudske jetre pokazala su da se atazanavir prvenstveno metabolizira putem izoenzima CYP3A4 do oksigeniranih metabolita.
REYATAZ oral powder contains 1305.15 mg of sucrose per sachet.
REYATAZ oralni prašak sadrži 1305,15 mg saharoze po vrećici.
During this time, postpartum patients should follow the same dose recommendation as for nonpregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Tijekom ovog vremena, bolesnice u postpartalnom razdoblju trebaju nastaviti s istom dozom kakva se preporučuje bolesnicama koje nisu trudne, uključujući one koje istovremeno primaju lijekove za koje se zna da utječu na izloženost atazanaviru (vidjeti dio 4.5).
AI424-451 (PRINCE II): In paediatric patients from 3 months to less than 11 years of age In these studies, 155 patients (59 antiretroviral-naive and 96 antiretroviral-experienced) received once daily REYATAZ oral powder and ritonavir, in combination with two NRTIs.
AI424-451 (PRINCE II): U pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 11 godina U tim ispitivanjima 155 bolesnika (59 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i 96 onih koji su prethodno bili liječeni antiretrovirusnim lijekovima) primalo je jednom dnevno REYATAZ oralni prašak i ritonavir u kombinaciji s dva NRTI-ja.
The withdrawal of ritonavir from the boosted regimen of REYATAZ is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions:
Iako se izostavljanje ritonavira iz pojačanog režima liječenja lijekom REYATAZ ne preporučuje, ono se može razmotriti u odraslih bolesnika uz dozu od 400 mg jedanput na dan primijenjenu s hranom, ali samo ako su zadovoljeni svi sljedeći restriktivni uvjeti:
Table 8: Efficacy Outcomes for oral powder (paediatric patients at least 3 months of age and weighing at least 5 kg) at Week 48 (Studies AI424-397 and AI424-451) Parameter
Tablica 8: Ishodi djelotvornosti za oralni prašak (pedijatrijski bolesnici u dobi od namanje 3 mjeseca i tjelesne težine od najmanje 5kg) u 48. tjednu (Isptivanje AI424-397 i AI424-451)
If you accidentally take more REYATAZ capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Ako slučajno uzmete više REYATAZ kapsula nego što je preporučio Vaš liječnik, odmah se obratite liječniku ili potražite savjet u najbližoj bolnici.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, Ireland
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa) također je bila prijavljena; međutim, prijavljeno vrijeme do nastanka je jako varijabilno, te ovi događaji mogu nastati puno mjeseci nakon početka liječenja (vidjeti dio 4.4.).
Patients who received REYATAZ or REYATAZ/ritonavir at any time prior to study enrollment or who had a history of treatment failure on two or more protease inhibitors, protease inhibitor resistance or evidence of pre-existing cardiac abnormalities were excluded from the trials.
Bolesnici koji su primali REYATAZ ili REYATAZ/ritonavir bilo kada prije uključivanja u ispitivanje ili su u anamnezi imali neuspjeh liječenja sa jedanim ili više inhibitora proteaze, rezistenciju na inhibitore proteaze, ili dokaz o postojećim srčanim abnormalnostima bili su isključeni iz ispitivanja.
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).
Zabilježeni su slučajevi osteonekroze, osobito u bolesnika s općenito poznatim čimbenicima rizika, uznapredovalom HIV-bolešću ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji.
Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristicd HIV RNA <100,000 copies/ml
48. tjedan: -3% [-7,6%, 1,5%] 96. tjedan: 2,2% [-2,3%, 6,7%] HIV RNK <50 kopija/ml, % prema početnim značajkamad HIV RNK <100 000 kopija/ml
100 mgd a The same recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and H2receptor antagonists in adults also apply to paediatric patients (see section 4.5).
100 mg d a Iste preporuke vezano uz vrijeme i maksimalnu dnevnu dozu istovremeno primijenjenog inhibitora protonske pumpe ili antagonista H2-receptora u odraslih također se primjenjuju na pedijattrijske bolesnike (vidjeti dio 4.5)
De novo substitutions in treatment naive patients failing therapy with atazanavir + ritonavir (Study 138, 96 weeks)
De novo supstitucije u bolesnika koji prethodno nisu bili liječeni i u kojih je podbacila terapija atazanavirom + ritonavirom (Ispitivanje 138, 96 tjedana)
* Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
* Prijavljen je učinak atazanavira i ritonavira na prvu dozu glecaprevira i pibrentasvira.
Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows: if you have hepatitis B or C if you develop signs or symptoms of gall stones (pain at the right side of your stomach) if you have type A or B haemophilia if you require haemodialysis
Obratite se svom liječniku ili ljekarniku prije nego uzmete REYATAZ i pobrinite se da liječnik zna: ako imate hepatitis B ili C ako se u Vas razviju znakovi ili simptomi žučnih kamenaca (bol na desnoj strani trbuha) ako imate hemofiliju tipa A B ako Vam je potrebna hemodijaliza
In clinical studies, REYATAZ (with or without ritonavir) has been shown to induce dyslipidaemia to a lesser extent than comparators.
U kliničkim se ispitivanjima pokazalo da REYATAZ (s ili bez ritonavira) izaziva dislipidemiju u manjem opsegu nego drugi slični lijekovi.
In clinical trial AI424-182 REYATAZ/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
U kliničkom je ispitivanju AI424-182 REYATAZ/ritonavir (300/100 mg ili 400/100 mg) u kombinaciji sa zidovudinom/lamivudinom bio primijenjen u 41 trudnice tijekom drugog ili trećeg tromjesečja.
The use of REYATAZ with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Primjena lijeka REYATAZ s ritonavirom može se uzeti u obzir tijekom trudnoće samo ako moguća korist opravdava mogući rizik.
Place the syringe in your child's mouth towards the cheek and push the plunger down to release the medicine.
Stavite štrcaljku u usta djeteta, unutar obraza i potisnite klip kako bi istisnuli lijek.
REYATAZ has not been studied in children less than 3 months of age and is not recommended because of the potential risk of kernicterus.
REYATAZ nije ispitan u djece mlađe od 3 mjeseca starosti i ne preporučjue se zbog mogućeg rizika od kernikterusa.
A: To mix the recommended number of REYATAZ oral powder sachets with liquid infant formula in a small medicine cup or small container and to administer with an oral syringe, which can be obtained from a pharmacist: A spoon is used to mix the content of the appropriate number of sachets (4 or 5 sachets depending on infant weight) with 10 ml of prepared liquid infant formula in the medicine cup or small container.
A: Za miješanje preporučenog broja vrećica REYATAZ oralnog praška, s tekućom dojenačkom formulom u maloj medicinskoj čaši ili malom spremniku za primjenu putem oralne štrcaljke koja se može dobiti od ljekarnika: Žlica se koristi kako bi se pomiješao sadržaj određenog broja vrećica (4-5 vrećica ovisno o tjelesnoj težini dojenčeta) s 10 ml pripremljene tekuće dojenačke formule u maloj medicinskoj čaši ili malom spremniku.
Some medicines may interact with ritonavir, a medicine that is taken with REYATAZ.
Neki lijekovi mogu ući u interakciju s ritonavirom, koji se uzima zajedno s lijekom REYATAZ.
The safety profile in these studies was overall comparable to that seen in previous paediatric and adult studies.
Sigurnosni profil u tim ispitivanjima općenito je bio usporediv s onime u prijašnjim pedijatrijskim ispitivanjima i ispitivanjima na odraslima.
common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to REYATAZ in randomised controlled and other available clinical trials (n = 2321).
često: umor; manje često: bol u prsištu, malaksalost, pireksija, astenija; rijetko: poremećaj hoda a Ove su nuspojave utvrđene u razdoblju nakon stavljanja lijeka u promet, premda, učestalost je procijenjena statističkim izračunom na temelju ukupnog broja bolesnika izloženih lijeku REYATAZ u randomiziranim kontroliranim i drugim dostupnim kliničkim ispitivanjima (n = 2321).
This association was observed independently of exposure to tenofovir disoproxil.
Ta povezanost je primijećena neovisno o izloženosti tenofovirdizoproksilu.
14-OH clarithromycin 14-OH clarithromycin AUC ↓70% 14-OH clarithromycin Cmax ↓72% 14-OH clarithromycin Cmin ↓62%
14-OH klaritromicin 14-OH klaritromicin AUC ↓70% 14-OH klaritromicin Cmax ↓72% 14-OH klaritromicin Cmin ↓62% (↓66%
Liver problems may uncommonly happen.
Manje često se mogu pojavit problemi s jetrom.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products (see section 4.8).
U slučaju istovremene antivirusne terapije zbog hepatitisa B ili C treba provjeriti odgovarajuće Sažetke opisa svojstava lijeka za te lijekove (vidjeti dio 4.8).
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Tjelesna težina i razine lipida i glukoze u krvi mogu biti povećane tijekom antiretrovirusne terapije (vidjeti dio 4.4.).
For the recommended paediatric dosage, REYATAZ oral powder contains 3915.45 mg sucrose per 150 mg atazanavir, 5220.60 mg sucrose per 200 mg atazanavir, 6525.75 mg sucrose per 250 mg atazanavir, and 7830.90 mg sucrose per 300 mg atazanavir.
Kod preporučenih pedijatrijskih doza REYATAZ oralni prašak sadrži 3915,45 mg saharoze na 150 mg atazanavira, 5220,60 mg saharoze na 200 mg atazanavira, 6525,75 mg saharoze na 250 mg atazanavira i 7830,90 mg saharoze na 300 mg atazanavira.
PHARMACEUTICAL FORM AND CONTENTS Carton and label bottle pack (1 bottle): 60 hard capsules Blister pack: 60 hard capsules
4. FARMACEUTSKI OBLIK I SADRŽAJ Kutija i boca s naljepnicom (1 boca): 60 tvrdih kapsula Blister pakiranje: 60 tvrdih kapsula
Elimination: following a single 400 mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Eliminacija: Nakon jednokratne doze od 400-mg 14C-atazanavira, 79% ukupne radioaktivnosti otkriveno je u stolici, a 13% u mokraći.
Stop taking REYATAZ and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules).
Odmah prestanite uzimati REYATAZ i obratite se liječniku ako se u Vas razviju teški osip ili ili osip sa simptomima bolesti nalik gripi mjehuriči, vrućica, ranice u ustima, bol u mišićima ili zglobovima, oticanje lica, upala oka koja uzrokuje crvenilo (konjunktivitis),bolni, topli ili crveni čvorići (noduli).
Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Koncentracije atazanavira jako su se smanjile kad je primijenjen istovremeno s didanozinom (puferirane tablete) i stavudinom.
For young infants (less than 6 months) who cannot eat solid food or drink from a cup, REYATAZ oral powder should be mixed with infant formula and given using an oral syringe, which can be obtained from a pharmacist.
Za mlađu dojenčad (mlađu od 6 mjeseci) koja ne može jesti krutu hranu ili piti iz čaše, REYATAZ oralni prašak može se pomiješati s dojenčakom formulom i dati pomoću oralne štrcaljke, koja se može zatražiti od ljekarnika.
Add 10 ml of prepared liquid infant formula and mix using a spoon.
2. Dodajte 10 ml pripremljene tekuće dojenačke formule i promiješatje koristeći žlicu.
Therefore, such coadministration is not recommended.
Stoga se njihova istovremena primjena ne preporučuje.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa) također je bila prijavljena prilikom imunološke reaktivacije; međutim, prijavljeno vrijeme do nastanka je jako varijabilno, te ovi događaji mogu nastati puno mjeseci nakon početka liječenja.
100 mgc aEach sachet contains 50 mg of REYATAZ bRitonavir oral solution cRitonavir oral solution or capsule/tablet
100 mg c aJedna vrećica sadrži 50 mg lijeka REYATAZ bRitonavir oralna otopina cRitonavir oralna otopina ili kapsule/tablete
Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil i vardenafil metabolizira enzim CYP3A4.
Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when coadministered with protease inhibitors.
Iako interakcija nije ispitivana, postoji mogućnost povećane izloženosti pravastatinu ili fluvastatinu kada se primjenjuju zajedno s inhibitorima proteaze.
The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Rizik od daljnjeg smanjenja izloženosti atazanaviru očekuje se kad se atazanavir daje s lijekovima za koje se zna da smanjuju izloženost atazanaviru (npr. tenofovirdizoproksil ili antagonisti H2-receptora).
The child is to drink the mixture.
Dijete treba popiti mješavinu.
Choose the appropriate option listed below for giving REYATAZ oral powder to your child.
3. Izaberite odgovarajući način primjene REYATAZ oralnog praška naveden dolje za svoje dijete.
Method of administration: For oral use.
Način primjene: Za peroralnu primjenu.
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.
Sistemski učinci kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde, zabilježeni su u bolesnika koji su primali ritonavir i inhalirali ili intranazalno primjenjivali flutikazon propionat; to se može dogoditi i s drugim kortikosteroidima koji se metaboliziraju putem P450 3A, npr., budezonidom.
Difference estimate [95% CI]d
Približna razlika [95% CI]d
Protease inhibitors: The co-administration of REYATAZ/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Inhibitori proteaze: Istovremena primjena lijeka REYATAZ s ritonavirom i drugih inhibitora proteaze nije ispitana, ali pretpostavlja se da bi povećala izloženost drugim inhibitorima proteaze.
Elevation in ALT levels were more frequently reported in paediatric patients in these studies than in adults.
Povišenje vrijednosti ALT je češće prijavljeno u ovim ispitivanjima u pedijatrijskih bolesnika nego u odraslih.
The use of REYATAZ may be considered during pregnancy only if the potential benefit justifies the potential risk.
Primjena lijeka REYATAZ može se uzeti u obzir tijekom trudnoće samo ako moguća korist opravdava mogući rizik.
The mechanism of interaction between REYATAZ/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Mehanizam interakcije između REYATAZ/ritonavir i sofosbuvir/velpatasvir/voksilaprevir je inhibicija OATP1B, Pgp, i CYP3A.
If an oral contraceptive is administered with REYATAZ/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Ako se oralna kontracepcija primjenjuje s lijekom REYATAZ s ritonavirom preporučje se da oralna kontracepcija sadrži najmanje 30 μg etinilestradiola i da se bolesnici istakne važnost redovitog uzimanja kontracepcije kod ovog kontracepcijskog režima.
For treatment-naive paediatric patients,
U prethodno liječenih pedijatrijskih bolesnika,
Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received REYATAZ capsules with ritonavir are presented in Table 7.
Podaci o djelotvornosti opaženoj u 41 pedijatrijskog bolesnika u dobi od 6 godina do manje od 18 godina koji su primali REYATAZ kapsule s ritonavirom prikazani su u tablici 7.
Co-administration of REYATAZ with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated.
Istovremena primjena lijeka REYATAZ s ritonavirom u dozama višima od 100 mg jedanput na dan nije klinički procijenjena.
The efficacy of REYATAZ/ritonavir in combination with tenofovir disoproxil fumarate in treatmentexperienced patients has been demonstrated in clinical study 045 and in treatment naive patients in clinical study 138 (see sections 4.8 and 5.1).
Djelotvornost lijeka REYATAZ s ritonavirom u kombinaciji s tenofovirdizoproksilfumaratom u prethodno liječenih bolesnika dokazana je u kliničkom ispitivanju 045, a u bolesnika koji prethodno nisu bili liječeni u kliničkom ispitivanju 138 (vidjeti dijelove 4.8 i 5.1).
Diabetic population
Dijabetička populacija
If you accidentally take or give more REYATAZ oral powder than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Ako slučajno uzmete ili date više REYATAZ oralnog praška nego što je preporučio Vaš liječnik, odmah se obratite liječniku ili potražite savjet u najbližoj bolnici.
Food effect: co-administration of REYATAZ and ritonavir with food optimises the bioavailability of atazanavir.
Utjecaj hrane: Istovremena primjena lijeka REYATAZ i ritonavira s hranom optimizira bioraspoloživost atazanavira.
Interactions between atazanavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Interakcije između atazanavira/ritonavira i inhibitora proteaze, amtiretrovirusnih lijekova koji nisu inhibitori proteaze i drugih lijekova koji nisu antiretrovirusni, navedene su u sljedećoj tablici (povišenje je označeno kao “↑”, sniženje kao “↓”, bez promjene kao “↔”).
*Ritonavir capsules, tablets or oral solution may be used.
* Mogu se uzimati Ritonavir kapsule, tablete ili oralna otopina.
Do not use an infant bottle to give REYATAZ mixed with infant formula.
Nemojte primjenjivati bocu za dojenče za primjenu lijeka REYATAZ pomiješanog s dojenačkom formulom.
Co-administration warrants clinical monitoring for sedation and cognitive effects.
Istovremena primjena zahtijeva kliničko praćenje zbog sedacije i kognitivnih učinaka.
e Number of patients evaluable.
e Broj bolesnika koje se moglo procijeniti.
Put another 10 ml of prepared infant formula in the cup or container and rinse the remaining oral powder from the cup or container.
5. Stavite dodatnih 10 ml pripremljene dojenačke formule u čašu ili spremnik i isperite ostatak oralnog praška iz čaše ili spremnika.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/001-006; 008-011
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/267/001-006; 008-011
Blister pack: 30 hard capsules
Blister pakiranje: 30 tvrdih kapsula
REYATAZ with food and drink See section 3 How to take REYATAZ.
REYATAZ s hranom i pićem Pogledajte dio 3.
b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
b Deset bolesnika imalo je na početku fenotipsku rezistenciju na atazanavir s ritonavirom (promjena ekspresije [FC] >5,2 puta).
REYATAZ (without ritonavir) has been studied in adult patients with severe renal impairment (n=20), including those on haemodialysis, at multiple doses of 400 mg once daily.
REYATAZ (bez ritonavira) ispitan je u odraslih bolesnika s teškim oštećenjem funkcije bubrega (n=20), uključujući one na hemodijalizi, pomoću višestrukih doza od 400 mg jedanput na dan.