natgillin/translations-raw huggingface dataset:
For children (at least 3 months of age and weighing at least 5 kg), your child's doctor will decide the right dose based on your child's weight.
Za djecu (u dobi od 3 mjeseca i tjelesne težine od najmanje 5 kg), liječnik Vašeg djeteta odlučit će koja je doza ispravna na temelju tjelesne težine Vašeg djeteta.
Metabolic parameters
Metabolički paramateri
The choice of REYATAZ in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Odabir lijeka REYATAZ za liječenje već liječenih odraslih i pedijatrijskih bolesnika treba biti utemeljen na pojedinačnom testiranju virusne rezistencije i prethodnom liječenju pojedinog bolesnika (vidjeti dijelove 4.4 i 5.1).
Blister pack: 60 hard capsules
Blister pakiranje: 60 tvrdih kapsula
Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Važno je istaknuti da su mnoga ispitivanja provedena s nepojačanim atazanavirom, što nije odobren oblik liječenja atazanavirom.
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product to your child.
Ako Vam je liječnik rekao da Vaše dijete ne podnosineke šećere, obratite se liječniku prije nego počnete davati svom djetetu ovaj lijek.
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing REYATAZ and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Drugi značajni kliničko-laboratorijski poremećaji (3. ili 4. stupnja) zabilježeni u ≥ 2% bolesnika koji su primali terapijske protokole s lijekom REYATAZ i jednim ili više NRTI-jeva uključivali su: povišenu kreatin kinazu (7%), povišen omjer alanin aminotransferaze i serumske glutamin-piruvatne transaminaze (ALT/SGPT) (5%), nizak broj neutrofila (5%), povišen omjer aspartat aminotransferaze i serumske glutamat-oksaloctene transaminaze (AST/SGOT) (3%) i povišenu lipazu (3%).
Do not take sildenafil with REYATAZ when sildenafil is used for the treatment of pulmonary arterial hypertension.
Nemojte uzimati sildenafil s lijekom REYATAZ kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
There are no pharmacokinetic data available for REYATAZ with ritonavir in patients with renal insufficiency.
Nema dostupnih farmakokinetičkih podataka za REYATAZ s ritonavirom u bolesnika s insuficijencijom bubrega.
In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic singlecell necrosis.
U ispitivanjima toksičnosti ponovljenih doza provedenih u miševa, štakora i pasa, nalazi povezani s atazanavirom općenito su bili ograničeni na jetru i uključivali su općenito minimalna do blaga povišenja serumskog bilirubina i jetrenih enzima, hepatocelularnu vakuolizaciju i hipertrofiju te, samo u ženki miša, nekrozu pojedinačnih jetrenih stanica.
Add 30 ml of the drink and mix with a spoon.
Dodajte 30 ml pića i promiješajte žlicom
Administration of REYATAZ with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and Cmax by approximately 25% compared to the fasting state.
Primjena lijeka REYATAZ s ritonavirom uz lagani obrok ili obrok bogat mastima smanjila je koeficijent varijacije AUC i Cmax za približno 25% u usporedbi s onima natašte.
The appropriate option listed below is chosen for mixing and administration with liquid infant formula, beverage or food.
2. Treba izabrati odgovarajući način naveden dolje, za miješanje i primjenu s tekućom dojenačkom formulom, pićem ili hranom.
Driving and using machines If you feel dizzy or lightheaded, do not drive or use machines, and contact your doctor immediately.
Ako osjetite omaglicu ili ošamućenost, nemojte voziti ili upravljati strojevima i odmah se obratite liječniku.
Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ capsules).
Provjerite tablicu doziranja za određenu formulaciju (vidjeti Sažetak opisa svojstava lijeka za REYTAZ kapsule).
Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily REYATAZ (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
U ovom su ispitivanju ukupno 182 pedijatrijska bolesnika (81 koji prethodno nisu bili liječeni i 101 prethodno liječeni antiretrovirusnim lijekovima) primala REYATAZ (kapsule ili u prašku) jedanput na dan, s ritonavirom ili bez njega, u kombinaciji s dva NRTI-ja.
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of REYATAZ (see section 4.4).
Stevens-Johnsonov sindrom (SJS), multiformni eritem, toksične kožne erupcije i medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS) zabilježeni su kod primjene lijeka REYATAZ (vidjeti dio 4.4).
The pharmacokinetics of atazanavir exhibit a non-linear disposition.
Farmakokinetika atazanavira pokazuje nelinearnu dispoziciju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
EXPIRY DATE EXP {MM/YYYY}
ROK VALJANOSTI EXP{MM/GGGG}
In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen (see section 4.4) The same recommendations for drug drug interactions would apply except: that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
Ako se ritonavir izostavi iz preporučenog režima liječenja atazanavirom pojačanim ritonavirom (vidjeti dio 4.4) Vrijede iste preporuke za interakcije između lijekova, osim sljedećega: Ne preporučuje se istovremena primjena s tenofovirom, boceprevirom, karbamazepinom, fenitoinom, fenobarbitalom, inhibitorima protonske pumpe i buprenorfinom.
SEDATIVES Benzodiazepines Midazolam Triazolam
Benzodiazepini Midazolam Triazolam
The safety and efficacy of REYATAZ has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost lijeka REYATAZ nije ustanovljena u bolesnika sa značajnom osnovnom bolešću jetre.
There is no specific antidote for overdose with REYATAZ.
Ne postoji posebni antidot za predoziranje lijekom REYATAZ.
When REYATAZ/ritonavir is co-administered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Kada se REYATAZ s ritonavirom primjenjuje istodobno s fenitoinom ili fenobarbitalom, možda će biti potrebna prilagodba doze fenitoina ili fenobarbitala.
In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with REYATAZ oral powder of 80 weeks.
U kliničkim ispitivanjima AI424-397 i AI424-451 u pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 11 godina, srednje trajanje liječenja REYATAZ oralnim praškom iznosilo je 80 tjedana.
Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir, high doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Ketokonazol i itrakonazol treba primjenjivati s oprezom kad se daju s lijekom REYATAZ /ritonavirom; ne preporučuju se visoke doze ketokonazola i itrakonazola (>200 mg na dan).
REYATAZ is also available in capsules for use in adults and children at least 6 years of age who weigh at least 15 kg and who are able to swallow the capsules.
REYATAZ je također dostupan u obliku kapsula za primjenu u odraslih i djece u dobi od najmanje 6 godina, tjelesne težine od najmanje 15 kg koja su u mogućnusti progutati kapsule.
Each bottle contains 60 hard capsules.
Jedna boca sadrži 60 tvrdih kapsula.
Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
U antiretrovirusnom liječenju prethodno liječenih bolesnika u Ispitivanjima 009, 043 i 045, u 100 izolata iz bolesnika u kojih je terapija atazanavirom, atazanavirom s ritonavirom ili atazanavirom sa sakvinavirom bila virološki neuspješna utvrđeno je da se razvila rezistencija na atazanavir.
REYATAZ/ritonavir is coadministered with clarithromycin.
REYATAZ/ritonavir primjenjuje istovremeno s klaritromicinom.
REYATAZ/ritonavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
REYATAZ/ritonavira treba primijeniti 2 sata prije ili 1 sat nakon antacida i puferiranih lijekova.
REYATAZ (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
REYATAZ (bez ritonavira) ispitivao se u odraslih ispitanika s umjerenim do teškim oštećenjem funkcije jetre (14 ispitanika s Child-Pugh stadijem B i 2 ispitanika s Child-Pugh stadijem C) nakon primjene jednokratne doze od 400 mg.
Withdrawal of ritonavir only under restrictive conditions The recommended standard treatment is REYATAZ boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Preporučeni standardni režim liječenja je REYATAZ pojačan ritonavirom, čime se osiguravaju optimalni farmakokinetički parametri i optimalna razina virološke supresije.
In paediatric patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk.
U pedijatrijskih bolesnika s već prisutnim poremećajem provođenja (atrioventrikularni blok drugog ili višeg stupnja ili kompletni blok grane) REYATAZ treba primjenjivati s oprezom i samo ako je korist veća od rizika.
Difference estimatee [95% CI]
Procjena razlikee [95% CI]
b Number of patients evaluable.
b Broj bolesnika koji se mogao procijeniti.
Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure.
Jedna kutija sadrži jednu bocu od polietilena visoke gustoće (HDPE) ili tri boce od polietilena visoke gustoće (HDPE), zatvorenu polipropilenskim zatvaračem sigurnim za djecu.
The most frequently reported laboratory abnormality in patients receiving regimens containing REYATAZ and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Najčešće zabilježeni laboratorijski nalaz u bolesnika koji primaju terapiju lijekom REYATAZ i jednim ili više NRTI-jeva bio je povišen ukupni bilirubin zabilježen pretežno kao povišeni indirektni [nekonjugirani] bilirubin (87% 1., 2., 3. ili 4. stupnja).
Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem Cmax ↑172% Desacetyl-diltiazem Cmin ↑121%
Dezacetil-diltiazem AUC ↑165% Dezacetil-diltiazem Cmax ↑172% Dezacetil-diltiazem Cmin ↑121%
C: To mix the recommended number of REYATAZ oral powder sachets with food such as applesauce or yogurt in a small container: One tablespoon of food is used to mix the content of the sachets.
C: Za miješanje preporučenog broja vrećica REYATAZ oralnog praška s hranom kao što je kašica od jabuke ili jogurt u malom spremniku: Jedna jušna žlica hrane koristi se da bi se promješao sadržaj vrećice.
Table 6: Efficacy Outcomes at Week 48a and at Week 96 (Study 045)
Tablica 6: Ishodi djelotvornosti u 48. tjednua i 96. tjednu (Ispitivanje 045)
Protease inhibitor resistance was defined as genotypic resistance to atazanavir or either component of the local NRTI backbone based on the criteria of 1) any major mutations: I50L, I84V, N88S and 2) ≥ 2 of the following minor or cross resistant mutations: M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I.
Rezistencija na inhibitore proteaze definirana je kao genotipska rezistencija na atazanavir ili bilo koji lijek koji je dio osnovnog liječenja u ksladu s nacionalnim smjernicama koje se sastoji od NRTI-ja, temeljem kriterija 1) bilo koja velika mutacija: I50L, I84V, N88S i 2) ≥ 2 od sljedećih malih ili unakrsno rezistentnih mutacija M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I.
If REYATAZ/ritonavir is coadministered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Ako se REYATAZ/ritonavir primjenjuje istovremeno s irinotekanom, bolesnike treba pažljivo pratiti zbog nuspojava povezanih s irinotekanom.
The residual mixture is drawn up into the syringe and administered into either the right or left inner cheek of the infant.
Preostali dio mješavine uvuče se u štrcaljku i primjeni s unutarnje strane desnog ili lijevog obraza dojenčeta.
CD4 count <50 cells/mm3
Broj CD4 stanica <50 stanica/mm3
The recommended adult dose of REYATAZ capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Preporučena doza REYATAZ kapsula za odrasle je 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan i s hranom, u kombinaciji s drugim anti-HIV lijekovima.
The dose of REYATAZ oral powder for children is calculated by body weight and is taken once daily with food and ritonavir as shown below:
Doza REYATAZ oralnog praška za djecu izračunava se na temelju tjelesne težine i uzima se jedanput na dan s hranom s ritonavirom na sljedeći način:
Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Među bolesnicima koji su primali REYATAZ 300 mg s ritonavirom 100 mg, učestalost žutice bila je 19%.
Rare (may affect up to 1 in 1,000 people): gait disturbance (abnormal manner of walking) oedema (swelling) hepatosplenomegaly (enlargement of the liver and spleen) myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) kidney pain
Rijetko (mogu se javiti u do 1 na 1000 osoba): poremećaj hoda (abnormalan način hodanja) edemi (oticanje), hepatosplenomegalija (povećanje jetre i slezene) miopatija (bolni mišići, osjetljivost na dodir i slabost mišića, što nije prouzročeno vježbanjem) bubrežni bolovi
Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Didanozin (puferirane tablete) 200 mg/stavudin 40 mg, oba u jednokratnoj dozi (atazanavir 400 mg, jednokratna doza)
Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ oral powder).
Provjerite tablicu doziranja za određenu formulaciju (vidjeti Sažetak opisa svojstava lijeka za REYATAZ oralni prašak).
Co-administration of a single 300 mg dose of REYATAZ and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Istovremena primjena jednokratne doze lijeka REYATAZ od 300 mg i doze ritonavira od 100 mg uz lagani obrok rezultirala je povećanjem AUC-a za 33% i povećanjem Cmax i 24-satne koncentracije atazanavira za 40% u odnosu na primjenu natašte.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze-galaktoze ili saharozaizomaltaza insuficijencijom ne smiju uzimati ovaj lijek.
Put the syringe tip into the mixture and pull back the plunger until the full amount of infant formula is taken up.
Stavite vrh štrcaljke u smjesu i povucite klip sve dok se puna količina dječje formule nije uvukla.
When given with REYATAZ/ritonavir, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Kad se daje s lijekom REYATAZ/ritonavira, preporučena doza rifabutina je 150 mg tri puta tjedno u određene dane (na primjer, ponedjeljak-srijeda-petak).
Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
Pedijatrijski bolesnici (u dobi od 6 godina do manje od 18 godina i tjelesne težine od najmanje 15 kg) Doza atazanavir kapsula za pedijatrijske bolesnike temelji se na tjelesnoj težini, kako je prikazano u tablici 1, i ne smije biti veća od preporučene doze za odrasle.
Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Jedna kutija sadrži 30 x 1 kapsulu; 5 blister kartica sa 6 x 1 kapsulom u perforiranom Al/Al blisteru djeljivom na pojedinačne doze.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with REYATAZ.
Osipi su obično blage do umjerene makulopapularne erupcije koje nastaju tijekom prva 3 tjedna od početka terapije lijekom REYATAZ.
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Bolesnici istovremeno zaraženi virusom hepatitisa B ili C Od 1151 bolesnika koji su primali atazanavir 400 mg jedanput na dan, 177 bolesnika istovremeno je imalo kroničnu infekciju virusom hepatitisa B ili C, dok je od 655 bolesnika koji su primali atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan, 97 bolesnika istovremeno imalo kroničnu infekciju virusom B ili C.
Study conducted in HIV infected patients
Ispitivanja provedena u bolesnika s HIV-infekcijom
In case of withdrawal of ritonavir from the initial recommended ritonavir boosted regimen (see section 4.4), unboosted REYATAZ could be maintained in patients with mild hepatic impairment at a dose of 400 mg, and in patients with moderate hepatic impairment with a reduced dose of 300 mg once daily with food (see section 5.2).
U slučaju izostavljanja ritonavira iz početnog preporučenog režima pojačanog ritonavirom (vidjeti dio 4.4), nepojačani REYATAZ može se nastaviti primjenjivati u boelsnika s blagim oštećenjem jetre u dozi od 400 mg, a u bolesnika s umjerenim oštećenjem funkcije jetre doza se mora smanjiti na 300 mg jedanput na dan i uzimati s hranom (vidjeti dio 5.2).
SPECIAL STORAGE CONDITIONS Does not require any special storage conditions.
Ne zahtijeva posebne uvjete čuvanja.
Alternative antiretroviral therapy to REYATAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Može se razmotriti primjena drugih antiretrovirusnih lijekova ako su žutilo kože ili sklera bolesniku neprihvatljivi.
B: To mix the recommended number of REYATAZ oral powder sachets with a beverage such as milk or water in a small drinking cup: A spoon is used to mix the content of the sachets with 30 ml of the beverage.
B: Za miješanje preporučenog broja vrećica REYATAZ oralnog praška s pićem kao što je mlijeko ili voda u maloj čaši: Žlica se koristi kako bi se promiješao sadržaj vrećica s 30 ml pića.
Integrase Inhibitors Raltegravir 400 mg twice daily (atazanavir/ritonavir)
Inhibitori integraze Raltegravir 400 mg dvaput na dan (atazanavir/ritonavir)
REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Sigurnost lijeka REYATAZ procijenjena je u kombiniranoj terapiji s drugim antiretrovirusnim lijekovima u kontroliranim kliničkim ispitivanjima u 1806 odraslih bolesnika koji su primali REYATAZ 400 mg jedanput na dan (1151 bolesnika, srednje trajanje liječenja 52 tjedna i maksimalno trajanje liječenja 152 tjedna) ili REYATAZ 300 mg s ritonavirom 100 mg jedanput na dan (655 bolesnika, srednje trajanje liječenja 96 tjedana i maksimalno trajanje liječenja 108 tjedana).
The child is to drink the entire residual mixture.
Dijete treba popiti u potpunosti preostali dio mješavine.
The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age.
Klinički podaci iz ovog ispitivanja nisu prikladni da bi se podržala primjena kapsula atazanavira (s ritonavirom ili bez njega) u djece mlađe od 6 godina.
For children who cannot eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and should be given using an oral syringe.
Kod djece koja ne mogu jesti krutu hranu ili piti iz čaše REYATAZ oralni prašak mora se pomiješati s dojenačkom formulom i potrebno ga je primijeniti koristeći oralnu štrcaljku.
Each carton contains 30 sachets.
Jedna kutija sadrži 30 vrećica.
Preparing and giving the medicine with drinks
Pripema i primjena lijeka s pićem
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
U bolesnika s već prisutnim poremećajima provođenja (atrioventrikularni blok drugog ili višeg stupnja ili kompletni blok grane) REYATAZ treba primjenjivati s oprezom i samo ako su koristi od liječenja veće od rizika (vidjeti dio 5.1).
Human experience of acute overdose with REYATAZ is limited.
Iskustvo s akutnim predoziranjem lijekom REYATAZ u ljudi je ograničeno.
rare: hepatosplenomegaly, cholecystitis a
rijetko: hepatosplenomegalija, kolecistitisa
Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of REYATAZ with sildenafil.
Vidjeti također PLUĆNA ARTERIJSKA HIPERTENZIJA u ovoj tablici za dodatne informacije o istovremenoj primjeni lijeka REYATAZ i sildenafila.
f Number of patients evaluable.
f Broj bolesnika koji su se mogli procijeniti.
Paediatric trials with REYATAZ capsules
Pedijatrijska ispitivanja s REYATAZ kapsulama
Through 96 weeks of treatment, mean HIV RNA changes from baseline for REYATAZ + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases.
Nakon 96 tjedana liječenja, prosječna promjena razine HIV RNK u odnosu na početnu vrijednost uz REYATAZ s ritonavirom i lopinavir s ritonavirom zadovoljila je kriterij neinferiornosti na temelju opaženih slučajeva.
When given with REYATAZ, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Kad se daje s lijekom REYATAZ, preporučena doza rifabutina je 150 mg tri puta tjedno u određene dane (na primjer, ponedjeljak-srijedapetak).
≥ 200 cells/mm3
≥ 200 stanica /mm3
Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Jedna kutija sadrži 60 x 1 kapsulu; 10 blister kartica sa 6 x 1 kapsulom u perforiranom Al/Al blisteru djeljivom na pojedinačne doze.
REYATAZ is also available as an oral powder for use in children at least 3 months old and weighing at least 5 kg.
REYATAZ je također dostupan u obliku oralnog praška za primjenu kod djece u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg.