natgillin/translations-raw huggingface dataset:
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ.
Inhibitori PDE5 koji se primjenjuju za liječenje erektilne disfunkcije: potreban je poseban oprez kad se propisuju inhibitori PDE5 (sildenafil, tadalafil ili vardenafil) za liječenje erektilne disfunkcije u bolesnika koji primaju REYATAZ.
Each bottle contains 30 hard capsules.
Jedna boca sadrži 30 tvrdih kapsula.
Didanosine should be taken at the fasted state 2 hours after REYATAZ/ritonavir taken with food.
Didanozin treba uzeti natašte 2 sata nakon uzimanja lijeka REYATAZ/ritonavira koji se uzima s hranom.
In HIV-infected patients (n=13), multiple dosing of REYATAZ 400 mg (without ritonavir) once daily with food produced a geometric mean (CV%) for atazanavir Cmax of 2298 (71) ng/ml, with time to Cmax of approximately 2.0 hours.
U bolesnika zaraženih HIV-om (n=13), višestruka primjena lijeka REYATAZ u dozi od 400 mg (bez ritonavira) jedanput na dan s hranom dovela je do geometrijske srednje vrijednosti (CV%) Cmax atazanavira od 2298 (71) ng/ml, uz vrijeme do postizanja Cmax od približno 2,0 sati.
80 mgc at least 35
80 mgc najmanje 35
The use of REYATAZ in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Primjena lijeka REYATAZ u djece mlađe od 3 mjeseca i tjelesne težine manje od 5kg nije ispitana zbog rizika od pojave ozbiljnih komplikacija.
Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine or pain when you urinate.
Odmah se obratite liječniku ako razvijete simptome bubrežnih kamenaca mogu uključivati bol u donjem dijelu leđa ili donjem dijelu trbuha, krv u mokraći ili bol pri mokrenju.
QUALITATIVE AND QUANTITATIVE COMPOSITION REYATAZ 100 mg hard capsules
2. KVALITATIVNI I KVANTITATIVNI SASTAV REYATAZ 100 mg tvrde kapsule
Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69%
Buprenorfin AUC ↑67% Buprenorfin Cmax ↑37% Buprenorfin Cmin ↑69%
REYATAZ given without ritonavir should not be considered in patients treated with a backbone regimen containing tenofovir disoproxil and with other concomitant medications that reduce atazanavir bioavailability (see section 4.5 In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen) or in case of perceived challenging compliance.
Primjena lijeka REYATAZ bez ritonavira ne smije se razmatrati u bolesnika liječenih osnovnim režimom koji sadrži tenofovirdizoproksil i drugim istovremeno primjenjivanim lijekovima koji smanjuju bioraspoloživost atazanavira (vidjeti odlomak "Ako se ritonavir izostavi iz preporučenog režima liječenja atazanavirom pojačanim ritonavirom" u dijelu 4.5), kao ni u bolesnika za koje se smatra da bi mogli imati poteškoća s pridržavanjem liječenja.
It is not known whether REYATAZ with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Nije poznato hoće li REYATAZ s ritonavirom primijenjen majci tijekom trudnoće pogoršati fiziološku hiperbilirubinemiju i dovesti do kernikterusa novorođenčeta i dojenčeta.
Concentrations of atazanavir were not significantly affected.
Koncentracije atazanavira nisu bile značajno promijenjene.
Frequency de novo PI substitution (n=26)a none none a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Učestalost de novo supstitucija za rezistenciju na inhibitor proteaze (n=26)a nijedna nijedna a Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml).
LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Simvastatin
Inhibitori reduktaze HMG-CoA Simvastatin
It is not known whether REYATAZ administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Nije poznato hoće li REYATAZ primijenjen majci tijekom trudnoće pogoršati fiziološku hiperbilirubinemiju i dovesti do kernikterusa novorođenčeta i dojenčeta.
g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
g Odabrane supstitucije uključuju svaku promjenu na položajima: L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84 i L90 (0-2, 3, 4 ili više) na početku.
As a result, greater peak to trough ratios are observed, however at recommended doses, geometric mean atazanavir exposures (Cmin, Cmax and AUC) in paediatric patients are expected to be similar to those observed in adults.
Kao posljedica, opaženi su veći omjeri vršnih i najnižih vrijednosti, no očekuje se da kod preporučenih doza, geometrijska srednja vrijednost i izloženosti atazanaviru (Cmin, Cmax i AUC) u pedijatrijskih bolesnika budu slična onoj primjećenoj u odraslih osoba.
postpartuma (n=36)
Nakon porođajaa (n=36)
Put the oral syringe tip into the mixture and pull back the plunger until the full amount of infant formula is taken up.
3. Stavite vrh oralne štrcaljke u mješavinu i povucite klip sve dok se puna količina dojenačke formule nije uvukla.
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
* U kombiniranoj analizi, atazanavir 300 mg s ritonavirom 100 mg (n=33) uspoređen je s atazanavirom 400 mg bez ritonavira (n=28).
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ with concomitant low-dose ritonavir.
Inhibitori PDE5 koji se primjenjuju za liječenje erektilne disfunkcije: potreban je poseban oprez kad se propisuju inhibitori PDE5 (sildenafil, tadalafil ili vardenafil) za liječenje erektilne disfunkcije u bolesnika koji primaju REYATAZ s istovremenom primjenom niske doze ritonavira.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir, atazanavir concentrations are expected to be additionally decreased by about 20%.
Kad se uspoređuje s atazanavirom 300 mg s ritonavirom 100 mg bez tenofovira, očekuje se da će koncentracije atazanavira biti dodatno smanjene za približno 20%.
A clean pair of scissors is used to cut each sachet along the dotted line.
Treba upotrijebiti čiste škare i i odrezati vrećicu uz točkastu liniju.
REYATAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
REYATAZ treba primijeniti 2 sata prije ili 1 sat nakon antacida i puferiranih lijekova.
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of REYATAZ/ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Smanjenje AUC, Cmax i Cmin nije bilo ublaženo privremenim vremenskim razmakom između povišene doze lijeka REYATAZ s ritonavirom (400/100 mg jedanput na dan) i omeprazola od 12 sati.
REYATAZ Dose once daily (mg)
REYATAZ doza jedanput na dan (mg)
Ritonavir Dose* once daily (mg)
Ritonavir doza* jedanput na dan (mg)
Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ (see section 4.4).
Bolesnike treba upozoriti na ove moguće nuspojave kad se inhibitori PDE5 za erektilnu disfunkciju uzimaju istovremeno s lijekom REYATAZ (vidjeti dio 4.4).
Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much REYATAZ.
Ako uzmete više lijeka REYATAZ nego što ste trebali Žutilo kože i/ili očiju (žutica) i nepravilni otkucaji srca (produženje QTc intervala) mogu se pojaviti ako Vaše dijete uzme previše lijeka REYATAZ.
REYATAZ should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
REYATAZ se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
In a non-clinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility (see section 5.3).
U nekliničkim ispitivanjima utjecaja na plodnost i rani embrionalni razvoj u štakora, atazanavir je promijenio ciklus estrusa bez učinaka na parenje ili plodnost (vidjeti dio 5.3).
The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 9.
Farmakokinetički podaci prikupljeni u trudnica zaraženih HIV-om koje su uzimale REYATAZ kapsule s ritonavirom prikazani su u tablici 9.
Larger volumes or quantities of liquid infant formula, beverage or food may be used.
Za doziranje se mogu primijeniti i veći volumeni ili količine tekuće dojenačke formule, pića ili hrane.
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% The mechanism is UGT1A1 inhibition.
Raltegravir AUC ↑41% Raltegravir Cmax↑24% Raltegravir C12hr↑77% Mehanizam je inhibicija UGT1A1.
For treatment-experienced paediatric patients, the mean baseline CD4 cell count was 1441 cells/mm
Za liječenje pedijatrijskih bolesnika koji su prethodno bili liječeni srednja početna vrijednost broja CD4 stanica bila je 1441 stanica /mm
Instructions for REYATAZ oral powder:
Upute za primjenu REYATAZ oralanog praška:
Fifteen of 120 (13%) patients in the REYATAZ + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
+ ritonavir i 17 od 123 (14%) bolesnika u skupini koja je primala lopinavir + ritonavir imalo je četiri ili više supstitucija za rezistenciju na inhibitore proteaze: L10, M46, I54, V82, I84 i L90.
Among patients who received REYATAZ 400 mg once daily or REYATAZ 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Među bolesnicima koji su primali REYATAZ 400 mg jedanput na dan ili REYATAZ 300 mg s ritonavirom 100 mg jedanput na dan, jedine vrlo često zabilježene nuspojave bilo koje težine s barem mogućom povezanošću s protokolima koji sadrže REYATAZ i jedan ili više NRTI-jeva bile su mučnina (20%), proljev (10%) i žutica (13%).
CD4 Mean Change from Baseline, cells/mm3 All patients
CD4 prosječna promjena od početne vrijednosti, stanice/mm3 Svi bolesnici
The REYATAZ/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
U skupini koja je primala REYATAZ/ritonavir utvrđena je antivirusna djelotvornost slična (neinferiorna) onoj u skupini koja je primala lopinavir/ritonavir, što je procijenjeno na temelju udjela bolesnika s HIV RNK < 50 kopija/ml u 48. tjednu (tablica 5).
Polyester film/Aluminum/Polyethylene sealant film sachet.
Troslojna vrećica od poliestera/aluminija/polietilena.
Atazanavir and fluconazole concentrations were not significantly modified when REYATAZ/ritonavir was co-administered with fluconazole.
Koncentracije atazanavira i flukonazola nisu bile značajno promijenjene kad se REYATAZ s ritonavirom primjenjivao istovremeno s flukonazolom.
common: rash; uncommon: erythemia multiforme a,b
manje često: multiformni eritem a,b
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder).
Pedijatrijski bolesnici (u dobi od najmanje 3 mjeseca i tjelesne težine odnajmanje 5 kg): REYATAZ oralni prašak dostupan je za pedijatrijske bolesnike u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg (vidjeti Sažetak opisa svojstava lijeka za REYATAZ oralni prašak).
QT prolongation: Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
Produljenje QT intervala: U kliničkim je ispitivanjima opaženo asimptomatsko produljenje PR intervala povezano s dozom lijeka REYATAZ.
If REYATAZ is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Ako se REYATAZ primjenjuje istovremeno s irinotekanom, bolesnike treba pažljivo pratiti zbog nuspojava povezanih s irinotekanom.
A large prospective observational study has shown an association between an increased incidence of chronic kidney disease and cumulative exposure to atazanavir/ritonavir-containing regimen in HIV-infected patients with an initially normal eGFR.
Veliko prospektivno opservacijsko ispitivanje pokazalo je povezanost između povećan incidencije kronične bubrežne bolesti i kumulativnog izlaganja režimu koji sadrži atazanavir/ritonavir u bolesnika zaraženih HIV-om, s početno norrmalnom eGFR.
The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 8.
Farmakokinetički podaci prikupljeni u trudnica zaraženih HIV-om koje su uzimale REYATAZ kapsule s ritonavirom prikazani su u tablici 8.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica s 1,5g oralnog praška sadrži 50 mg atazanavira (u obliku atazanavirsulfata).
In a per protocol analysis which excluded non-completers (i.e. patients who discontinued before the week 48 HIV RNA assessment) and patients with major protocol deviations, the proportion of patients with HIV RNA < 50 copies/ml at week 48 was 86% (338/392) for REYATAZ/ritonavir and 89% (332/372) for lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: -3% [95% CI, -7.6%,
Prema analizi po realiziranom protokolu koja je isključila bolesnike koji nisu dovršili ispitivanje (npr. bolesnici koji su prekinuli terapiju prije procjene HIV RNK u 48. tjednu) i bolesnike s velikim odstupanjima od protokola, udio bolesnika s HIV RNK < 50 kopija/ml u 48. tjednu bio je 86% (338/392) za REYATAZ/ritonavir i 89% (332/372) za lopinavir/ritonavir (procjena razlike ATV/RTVLPV/RTV: -3% [95% CI, -7,6%, 1,5%].
Co-administration with REYATAZ with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Istovremena primjena s lijekom REYATAZ i ritonavirom zahtijeva kliničko praćenje zbog sedacije i kognitivnih učinaka.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%.
Kad se uspoređuje s atazanavirom 300 mg s ritonavirom 100 mg bez tenofovirdizoproksilfumarata, očekuje se da će koncentracije atazanavira biti dodatno smanjene za približno 20%.
Patients exposed only to antiretrovirals in utero or intrapartum were considered treatment-naive.
Bolesnici koji su bili izloženi antiretrovirusnim lijekovima samo in utero i tijekom poroda smatrali su se bolesnicima koji nisu bili prethodno liječeni.
(See sections 4.2 and 4.4.)
(Vidjeti dio 4.4.
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ, based on these data.
Budući da se pokazalo da niska doza ritonavira (100 mg dvaput na dan) nema značajan učinak na koncentraciju metadona, na temelju tih se podataka ne očekuje interakcija kod istovremene primjene metadona i lijeka REYATAZ.
REYATAZ/ritonavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
REYATAZ/ritonavir se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ and ritonavir, based on these data.
Budući da se pokazalo da niska doza ritonavira (100 mg dvaput na dan) nema značajan učinak na koncentraciju metadona, na temelju tih se podataka ne očekuje interakcija kod istovremene primjene metadona i lijeka REYATAZ i ritonavira.
Three of 20 infants (15%) born to women treated with REYATAZ/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with REYATAZ/ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Troje od 20 dojenčadi (15%) žena liječenih s REYATAZ/ritonavirom 300/100 mg i četvero od 20 dojenčadi (20%) žena liječenih s REYATAZ/ritonavirom 400/100 mg imalo je bilirubin 3.-4. stupnja.
It is recommended that the INR be monitored carefully during treatment with
Preporučuje se pažljivo pratiti međunarodni normalizirani omjer (INR) tijekom liječenja lijekom
Among experienced patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Među prethodno liječenim bolesnicima koji su primali REYATAZ 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan tijekom srednjeg razdoblja od 95 tjedana, 53% imalo je povišenje ukupnog bilirubina 3.-4. stupnja.
* In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg co-administered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ritonavir 300/100 mg (n=33).
* U kombiniranoj analizi nekoliko kliničkih ispitivanja, atazanavir/ritonavir 300/100 mg primijenjeni istovremeno s tenofovirdizoproksilfumaratom 300 mg (n=39) uspoređivani su s atazanavirom/ritonavirom 300/100 mg (n=33).
In a clinical study AI424-020, paediatric patients 3 months to less than 18 years of age who received either the oral powder or capsule formulation had a mean duration of treatment with REYATAZ of 115 weeks.
U kliničkom ispitivanju AI424-020, u pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 18 godina, koji su primali ili formulaciju oralnog praška ili formulaciju kapsule, srednje trajanje liječenja lijekom REYATAZ iznosilo je 115 tjedana.
Determine the dose and the number of REYATAZ oral powder sachets needed (see section 3 How to take REYATAZ).
Odredite potrebnu dozu i broj vrećica REYATAZ oralnog praška (pogledajte dio 3.
REYATAZ + saquinavir was shown to be inferior to lopinavir + ritonavir.
Pokazalo se da je REYATAZ sa sakvinavirom inferioran kombinaciji lopinavira s ritonavirom.
For further details on the preparation and administration of the REYATAZ oral powder, see the Patient Information Leaflet, Instructions for Use section
Za dodatne informacije o pripremi i primjeni REYTAZ oralnog praška vidjeti u uputi o lijeku, u dijelu Upute za primjenu lijeka.
Paediatric trials with REYATAZ oral powder
Pedijatrijska ispitivanja s REYATAZ oralnim praškom
Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene closure.
Jedna kutija sadrži jednu bocu od polietilena visoke gustoće (HDPE) zatvorenu polipropilenskim zatvaračem sigurnim za djecu.
Norbuprenorphine AUC ↑105% Norbuprenorphine Cmax ↑61% Norbuprenorphine Cmin ↑101%
Norbuprenorfin AUC ↑105% Norbuprenorfin Cmax ↑61% Norbuprenorfin Cmin ↑101%
CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules twice daily)
KORTIKOSTEROIDI Flutikazon propionat intranazalno 50 µg 4 puta na dan tijekom 7 dana (ritonavir 100 mg kapsule dvaput na dan)
They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Djeluju tako što smanjuju količinu HIV-a u Vašem tijelu, što jača
Your child's doctor will decide the right dose based on your child's age and weight.
Liječnik Vašeg djeteta odlučit će o ispravnoj dozi na temelju tjelesne težine i dobi djeteta.
Table 1: Dose of REYATAZ oral powder with ritonavir for paediatric patientsa (at least 3 months of age and weighing at least 5 kg)
Tablica 1: Doza REYATAZ oralnog praška s ritonavirom za pedijatrijske bolesnikea (najmanje 3 mjeseca starosti i tjelesne težine od najmanje 5 kg)
When co-administered with tenofovir disoproxil fumarate, it is recommended that REYATAZ 300 mg be given with ritonavir 100 mg and tenofovir disoproxil fumarate 300 mg (all as a single dose with food).
Kada se REYATAZ primjenjuje istovremeno s tenofovirdizoproksilfumaratom, preporučuje se primijeniti 300 mg lijeka REYATAZ sa 100 mg ritonavira i 300 mg tenofovirdizoproksilfumatata (svi se primjenjuju kao jednokratna doza s hranom).
Two percent of patients treated with REYATAZ experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Dva posto bolesnika liječenih lijekom REYATAZ imalo je istovremeno ALT/AST 3.-4. stupnja i povišenje ukupnog bilirubina 3.-4. stupnja.
Six of 20 (30%) women on REYATAZ/ritonavir 300/100 mg and 13 of 21 (62%) women on REYATAZ/ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinaemia.
Šest od 20 (30%) žena koje su primale REYATAZ/ritonavir 300/100 mg i 13 od 21 (62%) žene koje su primale REYATAZ/ritonavir 400/100 mg razvilo je hiperbilirubinemiju 3. do 4. stupnja.
Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (see section 4.5).
Istodobna primjena lijekova koji sadrže grazoprevir, ukljućujući fiksnu kombinaciju elbasvir/grazoprevir (vidjeti dio 4.5).
Adverse reactions were consistent between patients who received REYATAZ 400 mg once daily and patients who received REYATAZ 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with REYATAZ plus ritonavir.
Nuspojave u bolesnika koji su primali REYATAZ 400 mg jedanput na dan bile su sukladne nuspojavama u bolesnika koji su primali REYATAZ 300 mg s ritonavirom 100 mg jedanput na dan, osim što su žutica i povišene razine ukupnog bilirubina bile zabilježene češće uz REYATAZ s ritonavirom.
Clarithromycin AUC ↑94% (↑75% Clarithromycin Cmax ↑50% (↑32% Clarithromycin Cmin ↑160% (↑135%
Klaritromicin AUC ↑94% (↑75% Klaritromicin Cmax ↑50% (↑32% Klaritromicin Cmin ↑160% (↑135%
The dose of REYATAZ capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Doza REYATAZ kapsula za djecu izračunava se na temelju tjelesne težine i uzima se jedanput na dan s hranom i 100 mg ritonavira na sljedeći način:
If a higher dose of an H2-receptor antagonist is required (eg, famotidine 40 mg twice daily or equivalent) an increase of the REYATAZ/ritonavir dose from 300/100 mg to 400/100 mg can be considered.
Ako je potrebna viša doza antagonista H2 receptora (npr., famotidin 40 mg dvaput na dan ili ekvivalent) može se razmotriti povišenje doze lijeka REYATAZ s ritonavirom s 300/100 mg na 400/100 mg.
Co-administration with REYATAZ has the potential to increase or decrease warfarin concentrations.
Istovremena primjena s lijekom REYATAZ može povisiti ili sniziti koncentracije varfarina.
If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to REYATAZ 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
Ako je potrebno primijeniti tenofovirdizoproksil ili antagonist H2-receptora, možda će trebati razmotriti povećanje doze lijeka REYATAZ na 400 mg primijenjenu s ritonavirom od 100 mg uz praćenje koncentracije lijeka (vidjeti dijelove 4.6 i 5.2).
Combination of rifampicin with concomitant low-dose ritonavir (see section 4.5).
Kombinacija rifampicina s istovremenom niskom dozom ritonavira (vidjeti dio 4.5)
NAME OF THE MEDICINAL PRODUCT REYATAZ 50 mg oral powder
NAZIV LIJEKA REYATAZ 50 mg oralni prašak