natgillin/translations-raw huggingface dataset:
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
35 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
34 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Pri velikih odmerkih, ki povzročijo veliko izpostavljenost zdravilu, se lahko pojavita zlatenica, ki je posledica indirektne (nekonjugirane) hiperbilirubinemije (brez spremljajočih sprememb testov jetrnih funkcij), ali podaljšanje intervala PR (glejte poglavji 4. 4 in 4. 8).
Since atazanavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
36 izdatno presnavlja v jetrih in se v veliki meri veže na beljakovine v plazmi, zato ni verjetno, da bi dializa kaj dosti koristila pri njegovi odstranitvi.
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
37 Klinični rezultati Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri 883 bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, primerjalo uporabo zdravila REYATAZ/ ritonavirja (300 mg/ 100 mg enkrat na dan) z uporabo lopinavirja/ ritonavirja (400 mg/ 100 mg dvakrat na dan), oboje v kombinaciji s fiksnimi odmerki tenofovirja/ emtricitabina (300 mg/ 200 mg tablete enkrat na dan).
36 CD4 count
Število celic CD4
38 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.
Izločanje: po enkratnem 400- mg odmerku s 14C - označenega atazanavirja se je 79% radioaktivnosti pojavilo v blatu in 13% v urinu.
Age/ Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
40 Starost/ spol: farmakokinetične študije atazanavirja so bile izvedene pri 59 zdravih preiskovancih in preiskovankah (29 mladih, 30 starejših).
39 produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Med pred - in postnatalno oceno razvoja pri podganah je atazanavir povzročil prehodno zmanjšanje telesne mase mladičev pri maternalno toksičnih odmerkih.
Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
41 Atazanavir je v in vitro študiji očesnega draženja zvečal opalescenco goveje roženice, kar kaže, da bi ob neposrednem stiku z očesom lahko povzročil draženje.
Each capsule contains 200 mg of atazanavir (as sulphate)
Ena kapsula vsebuje 200 mg atazanavirja (v obliki sulfata).
109.57 mg of lactose per capsule.
109, 57 mg laktoze na kapsulo
Hard capsule Opaque blue capsule printed with white ink, with "BMS 200 mg" on one half and with "3631" on the other half.
Oznaki sta bele barve.
42 Method of administration: for oral administration.
Način uporabe: za peroralno uporabo.
43 There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
45 Pri bolnikih s hemofilijo A ali B, ki so dobivali zaviralce proteaz, so poročali o pogostejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
44 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
46 mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
47 terapevtski indeks, npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4. 3).
45 Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
Druge interakcije V spodnji tabeli so navedene interakcije med atazanavirjem/ ritonavirjem in zaviralci proteaz, drugimi protiretrovirusnimi zdravili ter drugimi neprotiretrovirusnimi zdravili (zvišanje je navedeno kot “ ↑ ”, znižanje kot “ ↓ ”, brez spremembe kot “ ↔ ”, dvakrat na dan kot “ 2x/ dan ” in enkrat na dan kot “ 1x/ dan ”).
46
↔ 1, 03
47 Co-administered medicinal
ritonavir uporablja skupaj s
48 Co-administered medicinal
Sočasno uporabljena
49
Varfarin
50 Co-administered medicinal
Sočasno uporabljena
Adult patients The following adverse reactions of moderate intensity or greater with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs have also been reported.
55 Odrasli bolniki Poročali so tudi o naslednjih neželenih učinkih zmerne ali močneje jakosti, ki bi vsaj lahko bili povezani s terapevtskimi shemami, ki so vključevale zdravilo REYATAZ in enega ali več nukleozidnih/ nukleotidnih zaviralcev reverzne transkriptaze.
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
56 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
54 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Pri velikih odmerkih, ki povzročijo veliko izpostavljenost zdravilu, se lahko pojavita zlatenica, ki je posledica indirektne (nekonjugirane) hiperbilirubinemije (brez spremljajočih sprememb testov jetrnih funkcij), ali podaljšanje intervala PR (glejte poglavji 4. 4 in 4. 8).
Since atazanavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
57 izdatno presnavlja v jetrih in se v veliki meri veže na beljakovine v plazmi, zato ni verjetno, da bi dializa kaj dosti koristila pri njegovi odstranitvi.
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
58 Klinični rezultati Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri 883 bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, primerjalo uporabo zdravila REYATAZ/ ritonavirja (300 mg/ 100 mg enkrat na dan) z uporabo lopinavirja/ ritonavirja (400 mg/ 100 mg dvakrat na dan), oboje v kombinaciji s fiksnimi odmerki tenofovirja/ emtricitabina (300 mg/ 200 mg tablete enkrat na dan).
56 CD4 count
Število celic CD4
5.2 Pharmacokinetic properties
60 5. 2 Farmakokinetične lastnosti
58 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.
Izločanje: po enkratnem 400- mg odmerku s 14C - označenega atazanavirja se je 79% radioaktivnosti pojavilo v blatu in 13% v urinu.
Age/ Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
61 Starost/ spol: farmakokinetične študije atazanavirja so bile izvedene pri 59 zdravih preiskovancih in preiskovankah (29 mladih, 30 starejših).
59 produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Med pred - in postnatalno oceno razvoja pri podganah je atazanavir povzročil prehodno zmanjšanje telesne mase mladičev pri maternalno toksičnih odmerkih.
Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
62 Atazanavir je v in vitro študiji očesnega draženja zvečal opalescenco goveje roženice, kar kaže, da bi ob neposrednem stiku z očesom lahko povzročil draženje.
60 Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/ Alu perforated unit dose blisters.
Ena škatla vsebuje 60 x 1 kapsulo; 10 pretisnih omotov s 6 x 1 kapsulo v enoodmernem alu/ alu perforiranem pretisnem omotu.
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
63 BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Velika Britanija
Each capsule contains 300 mg of atazanavir (as sulphate)
Ena kapsula vsebuje 300 mg atazanavirja (v obliki sulfata).
164.36 mg of lactose per capsule.
164, 36 mg laktoze na kapsulo
Hard capsule Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half.
Oznaki sta bele barve.
62 Method of administration: for oral administration.
Način uporabe: za peroralno uporabo.
63 There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
66 Pri bolnikih s hemofilijo A ali B, ki so dobivali zaviralce proteaz, so poročali o pogostejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
64 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
67 mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
68 terapevtski indeks, npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4. 3).
65 Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
Druge interakcije V spodnji tabeli so navedene interakcije med atazanavirjem/ ritonavirjem in zaviralci proteaz, drugimi protiretrovirusnimi zdravili ter drugimi neprotiretrovirusnimi zdravili (zvišanje je navedeno kot “ ↑ ”, znižanje kot “ ↓ ”, brez spremembe kot “ ↔ ”, dvakrat na dan kot “ 2x/ dan ” in enkrat na dan kot “ 1x/ dan ”).
The co-administration of
ddI+d4T (na tešče) atazanavir,
(0.08, 0.21) (0.06, 0.18) (0.10, 0.27) with ddI+d4T
(0, 10; 0, 27)
REYATAZ/ ritonavir
sočasni uporabi zdravila REYATAZ / ritonavirja s
(fasted)
(0, 61; 1, 73)
with stavudine is not expected to
pomembnejših sprememb v
atazanavir, dosed ↔ 1.03 ↑ 1.12 ↔ 1.03 1 hr after ddI+d4T (0.64, 1.67) (0.67, 1.18) (0.61, 1.73) (fasted) Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Pri sočasni uporabi z didanozinom (pufrane tablete) in s stavudinom so se izpostavljenosti koncentracije atazanavirja močno zmanjšale.
The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Mehanizem te interakcije je stavudinu ne manjša topnost atazanavirja pri višjem pH- ju zaradi antacidnega sredstva v pričakujemo. didanozin pufranih tabletah.
significantly alter the exposure of stavudine.
Didanozin (skupaj
66
↓ 0, 66
67 Co-administered medicinal
ritonavir uporablja skupaj s
68 Co-administered medicinal
Sočasno uporabljena
69
Varfarin
needed and ECG monitoring
↑ 2, 65
Verapamil CORTICOSTEROIDS
↑ 2, 72
Serum concentrations of verapamil may be increased by REYATAZ/ ritonavir due to CYP3A4 inhibition..
↑ 2, 21
Caution should be exercised when verapamil is co-administered with REYATAZ/ ritonavir
kasnejše povečevanje
Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules BID) ERECTILE DYSUNCTION PDE5 Inhibitors
(2, 45; 2, 87)
The mechanism of interaction is CYP3A4 inhibition.
(2, 44; 3, 03)
Co-administration of REYATAZ/ ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
(2, 02; 2, 42)
Sildenafil
odmerka v skladu s spremljanjem EKG.
Sildenafil is metabolised by CYP3A4.
Pomembnih učinkov na koncentracije atazanavirja niso opazili.
Co-administration with REYATAZ/ ritonavir may result in increased concentrations of sildenafil and an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism.
V primerjavi z uporabo atazanavirja samega so poročali o podaljšanju najdaljšega PR intervala.
The mechanism of the sildenafil/ atazanavir interaction is CYP3A4 inhibition.
Sočasne uporabe diltiazema in zdravila REYATAZ / ritonavirja niso raziskovali.
Patients should be warned about these possible side effects.
Mehanizem interakcije diltiazem/ atazanavir je inhibicija CYP3A4.
HERBAL PRODUCTS
Verapamil KORTIKOSTEROIDI
John’ s wort (Hypericum perforatum):
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se lahko serumske koncentracije verapamila povečajo zaradi inhibicije CYP3A4..
John's wort with REYATAZ/ ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja in verapamila je potrebna previdnost.
Co-administration of REYATAZ/ ritonavir
Flutikazonpropionat za
70 Co-administered medicinal
Plazemske vrednosti flutikazonpropionata so se znatno povečale,
Medicinal
Sočasne uporabe
AUC
73
Cmax
Sočasno uporabljena
Cmin
Vrednoteno AUC Cmax Cmin
co-administration
intranazalno uporabo 50 µg 4 krat na dan, 7 dni (ritonavir 100 mg kapsule 2x/ dan) ZDRAVILA ZA ZDRAVLJENJE EREKTILNE DISFUNKCIJE Zaviralci PDE5
This effect may be due to an induction of CYP3A4.
Mehanizem interakcije je inhibicija CYP3A4.
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
zdravila REYATAZ / ritonavirja in teh glukokortikoidov ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4. 4).
with products containing St.
Sildenafil se presnavlja s CYP3A4.
John's wort is contraindicated.
Bolnike je treba opozoriti na te možne neželene učinke.
HORMONAL CONTRACEPTIVES
PRIPRAVKI RASTLINSKEGA IZVORA
Ethinyloestradiol 35 μ g + norethindrone (atazanavir 400
HORMONSKI KONTRACEPTIVI
The co-administration of
Ta učinek je lahko posledica indukcije CYP3A4.
mg QD) LIPID LOWERING AGENTS HMG-CoA reductase inhibitors
Etinilestradiol 35 μg + noretindron (atazanavir 400 mg 1x/ dan)
The concentration of oral contraceptives was increased due to UGT inhibition.
Sočasni uporabi zdravila REYATAZ/ ritonavirja
In contrast, ritonavir may decrease ethinyloestradiol concentrations.
Zaradi zaviranja UGT so se koncentracije peroralnih kontraceptivov in peroralnih povečale.
The effects of co-administration of oral contraceptives and REYATAZ/ ritonavir have not been studied.
Nasprotno po lahko ritonavir zmanjša koncentracije kontraceptivov se je etinilestradiola.
REYATAZ/ ritonavir and oral contraceptives should be avoided (see section 4.4).
Učinka sočasne uporabe peroralnih kontraceptivov in treba izogibati (glejte zdravila REYATAZ/ ritonavirja niso raziskovali. poglavje 4. 4).
Alternate reliable methods of contraception should be considered.
Razmisliti je treba o uporabi druge zanesljive metode kontracepcije.
Simvastatin Lovastatin
ZDRAVILA ZA ZMNAJŠANJE RAVNI LIPIDOV Zaviralci reduktaze HMG- CoA Simvastatin Lovastatin
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ/ ritonavir may result in increased concentrations.
Pri sočasni uporabi zdravila REYATAZ/ ritonavirja se lahko koncentracije povečajo.
4.6 Pregnancy and lactation
75 4. 6 Nosečnost in dojenje
Adult patients The following adverse reactions of moderate intensity or greater with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs have also been reported.
76 Odrasli bolniki Poročali so tudi o naslednjih neželenih učinkih zmerne ali močneje jakosti, ki bi vsaj lahko bili povezani s terapevtskimi shemami, ki so vključevale zdravilo REYATAZ in enega ali več nukleozidnih/ nukleotidnih zaviralcev reverzne transkriptaze.
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
77 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
74 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Pri velikih odmerkih, ki povzročijo veliko izpostavljenost zdravilu, se lahko pojavita zlatenica, ki je posledica indirektne (nekonjugirane) hiperbilirubinemije (brez spremljajočih sprememb testov jetrnih funkcij), ali podaljšanje intervala PR (glejte poglavji 4. 4 in 4. 8).
Since atazanavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
78 izdatno presnavlja v jetrih in se v veliki meri veže na beljakovine v plazmi, zato ni verjetno, da bi dializa kaj dosti koristila pri njegovi odstranitvi.
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
79 Klinični rezultati Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri 883 bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, primerjalo uporabo zdravila REYATAZ/ ritonavirja (300 mg/ 100 mg enkrat na dan) z uporabo lopinavirja/ ritonavirja (400 mg/ 100 mg dvakrat na dan), oboje v kombinaciji s fiksnimi odmerki tenofovirja/ emtricitabina (300 mg/ 200 mg tablete enkrat na dan).
76 CD4 count
Število celic CD4
5.2 Pharmacokinetic properties
81 5. 2 Farmakokinetične lastnosti
78 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.
Izločanje: po enkratnem 400- mg odmerku s 14C - označenega atazanavirja se je 79% radioaktivnosti pojavilo v blatu in 13% v urinu.
Age/ Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
82 Starost/ spol: farmakokinetične študije atazanavirja so bile izvedene pri 59 zdravih preiskovancih in preiskovankah (29 mladih, 30 starejših).
79 produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Med pred - in postnatalno oceno razvoja pri podganah je atazanavir povzročil prehodno zmanjšanje telesne mase mladičev pri maternalno toksičnih odmerkih.
Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
83 Atazanavir je v in vitro študiji očesnega draženja zvečal opalescenco goveje roženice, kar kaže, da bi ob neposrednem stiku z očesom lahko povzročil draženje.
Gelatine Red iron oxide Black iron oxide Yellow iron oxide Indigocarmin (E132) Titanium dioxide (E171)
Ovojnice kapsul: želatina Rdeči železov oksid Črni železov oksid Rumeni železov oksid indigotin (E132) titanov dioksid (E 171)
80 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure.
Plastenka je zaprta s polipropilensko zaporko, varno za otroke.
Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/ Alu perforated unit dose blisters.
Ena škatla vsebuje 30 x 1 kapsulo; 5 pretisnih omotov s 6 x 1 kapsulo v enoodmernem alu/ alu perforiranem pretisnem omotu.
REYATAZ 50 mg/ 1.5 g oral powder
REYATAZ 50 mg/ 1, 5 g peroralni prašek
One measuring spoon of 1.5 g oral powder contains 50 mg atazanavir (as sulphate).
Ena merilna žlička z 1, 5 g peroralnega praška vsebuje 50 mg atazanavirja (v obliki sulfata).
150 mg of aspartame and 1,218.15 mg of sucrose per measuring spoon of 1.5 g oral powder
150 mg aspartama in 1. 218, 15 mg saharoze na merilno žličko z 1, 5 g peroralnega praška
Off-white to pale yellow powder.
Sivobel do bledorumen prašek.
REYATAZ oral powder is available for patients who are unable to swallow capsules.
Odrasli: peroralni prašek REYATAZ je na voljo za bolnike, ki ne morejo pogoltniti kapsul.
The recommended dose of oral powder is 300 mg (6 level measuring spoons) once daily taken with ritonavir 100 mg once daily and with food.
Priporočeni odmerek peroralnega praška je 300 mg (6 rezanih merilnih žličk) enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan in skupaj s hrano.
One measuring spoon of 1.5 g of oral powder contains 50 mg atazanavir.
Ena merilna žlička z 1, 5 g peroralnega praška vsebuje 50 mg atazanavirja.
Patients with hepatic impairment:
86 Bolniki z okvaro jeter:
REYATAZ with ritonavir should be used with caution in patients with mild
Pri bolnikih z blago okvaro jeter je treba zdravilo REYATAZ z ritonavirjem uporabljati previdno.
REYATAZ should not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Zdravila REYATAZ se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavja 4. 3, 4. 4 in 5. 2).
The oral powder should be taken with food.
Peroralni prašek je treba jemati skupaj s hrano.