natgillin/translations-raw huggingface dataset:
Co-administration with atazanavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
Istovremena primjena s atazanavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s PDE5, uključujući hipotenziju, poremećaje vida i prijapizam.
Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for atazanavir + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Nakon 48 tjedana liječenja, prosječna promjena razine HIV RNK u odnosu na početnu vrijednost uz atazanavir s ritonavirom bila je slična (neinferiorna) onoj uz lopinavir s ritonavirom.
No dose adjustment is needed for atazanavir.
Nije potrebna prilagodba doze atazanavira.
• oedema (swelling)
• edemi (oticanje)
Study 045 is a randomised, multicenter trial comparing atazanavir /ritonavir (300/100 mg once daily) and atazanavir /saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil fumarate (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Ispitivanje 045 randomizirano je, multicentrično ispitivanje u kojem su atazanavir/ritonavir (300/100 mg jedanput na dan) i atazanavir/sakvinavir (400/1200 mg jedanput na dan) uspoređivani s lopinavirom + ritonavirom (400/100 mg, fiksna kombinacija doza, dvaput na dan), a svaka se od tih terapija primjenjivala u kombinaciji s tenofovirdizoproksilfumaratom (vidjeti dijelove 4.5 i 4.8) i jednim NRTI-jem u bolesnika u kojih je dva ili više prethodnih protokola s najmanje jednim inhibitorom proteaze, NRTI-jem i NNRTI-jem bilo virološki neuspješno.
The recommended dose of atazanavir is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Preporučena doza atazanavira je 300 mg jedanput na dan i uzima se s ritonavirom u dozi od 100 mg jedanput na dan i s hranom.
Co-administration of atazanavir with ritonavir and proton pump inhibitors is not recommended.
Ne preporučuje se istovremena primjena atazanavira s ritonavirom i inhibitorima protonske pumpe.
Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing atazanavir/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u bolesnika koji prethodno nisu bili liječeni u kojem se atazanavir/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoproksilfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
Skin and subcutaneous tissue disorders: common: rash; uncommon: erythemia multiforme a,b
često: osip; manje često: multiformni eritem a,b
HIV RNA <50 copies/ml, %
HIV RNK <50 kopija/ml, %
HIV RNA <50 copies/ml by select baseline PI substitutions,
b) HIV RNK <50 kopija/ml prema početnim odabranim supstitucijama za rezistenciju na inhibitor proteaze,
If the co-administration of Atazanavir Mylan with an NNRTI is required, an increase in the dose of both Atazanavir Mylan and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Ako je potrebno istovremeno primjenjivati Atazanavir Mylan s nekim NNRTI-jem, može se razmotriti povišenje doze lijeka Atazanavir Mylan na 400 mg i ritonavira na 200 mg u kombinaciji s efavirenzom, uz pažljivo praćenje bolesnika.
Proton pump inhibitors Omeprazole 40 mg once daily
Inhibitori protonske pumpe Omeprazol 40 mg jedanput na dan
(400 mg/100 mg twice daily) n=443
(400 mg/100 mg dvaput na dan) n=443
The combination of rifampicin and atazanavir is contraindicated (see section 4.3).
Kombinacija rifampicina i atazanavira je kontraindicirana (vidjeti dio 4.3).
Additional minor metabolic pathways consist of
Dodatni manji metabolički putovi sastoje se od N-dezalkilacije i hidrolize.
Concomitant use of St. John's wort with atazanavir may be expected to result in significant reduction in plasma levels of atazanavir.
Može se očekivati da istovremena primjena gospine trave i atazanavira rezultira značajnim sniženjem razine atazanavira u plazmi.
Ethinyloestradiol Cmin ↓37% (↓45%
Etinilestradiol Cmin ↓37% (↓45%
common: jaundice; uncommon: hepatitis, cholelithiasis a, cholestasis a;
često: žutica; manje često: hepatitis, kolelitijaza a, kolestaza a;
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Indinavir je povezan s indirektnom hiperbilirubinemijom zbog povišenja nekonjugiranog bilirubina, što je posljedica inhibicije UGT.
Lamotrigine should be used with caution in combination with atazanavir/ritonavir.
Lamotrigin se mora primjenjivati uz oprez u kombinaciji s atazanavirom i ritonavirom.
There was less hyperbilirubinaemia and jaundice in the unboosted atazanavir group compared with the atazanavir + ritonavir group (18 and 28 subjects, respectively).
U skupini liječenoj nepojačanim atazanavirom zabilježeno je manje slučajeva hiperbilirubinemije i žutice nego u skupini koja je primala atazanavir + ritonavir (18 naspram 28 ispitanika).
6.5 Nature and contents of container
6.5 Vrsta i sadržaj spremnika 150 mg
Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 4.3).
Atazanavir se prvenstveno metabolizira u jetri, pa su u bolesnika s oštećenjem jetre bile opažene povišene koncentracije atazanavira u plazmi (vidjeti dijelove 4.2 i 4.3).
Due to CYP3A4 inhibition by atazanavir, concentrations of quetiapine are expected to increase.
Budući da atazanavir inhibira CYP3A4, očekuje se povećanje koncentracija kvetiapina.
* When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily and tenofovir disoproxil fumarate 300 mg all as a single dose with food.
* Kad se uspoređuje s atazanavirom 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan i tenofovirdizoproksilfumaratom 300 mg, svi primijenjeni kao jednokratna doza s hranom.
Atazanavir with ritonavir has not been studied in patients with hepatic impairment.
Atazanavir s ritonavirom nije ispitan u bolesnika s oštećenjem funkcije jetre.
150 mg capsules
150 mg kapsule
Antiretroviral treatment experienced adult patients
Antiretrovirusno liječenje prethodno liječenih bolesnika
Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
U bolesnika koji su primali atazanavir nastupilo je reverzibilno povišenje indirektnog (nekonjugiranog) bilirubina povezano s inhibicijom UDP-glukuronozil transferaze (UGT) (vidjeti dio 4.8).
60 x 1 hard capsules.
60 x 1 tvrda kapsula.
• muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
• mišićna atrofija (gubitak mišića), artralgija (bol u zglobovima), mialgija (bol u mišićima)
Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir.
U bolesnika koji uzimaju atazanavir zabilježen je ozbiljni kožni osip, uključujući Stevens-Johnsonov sindrom.
Tenofovir disoproxil fumarate 300 mg once daily
Tenofovirdizoproksilfumarat 300 mg jedanput na dan
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Učestalost hepatitisa ili povišenja transaminaza koji su se u bolesnika s istovremenim infekcijama razvili tijekom liječenja atazanavir bila je slična onoj pri primjeni komparatorskih protokola (vidjeti dio 4.4).
The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir.
Mehanizam interakcije je inhibicija enzima CYP3A4 atazanavirom i/ili ritonavirom.
Chronic kidney disease
Kronična bubrežna bolest
Voriconazole AUC ↓33% (↓42%
Vorikonazol AUC ↓33% (↓42%
Combinations of atazanavir and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Kombinacije atazanavira i indinavira nisu ispitane pa se ne preporučuje njihova istovremena primjena (vidjeti dio 4.5).
In clinical trials of antiretroviral treatment naive patients treated with boosted atazanavir, the I50L substitution did not emerge in any patient without baseline PI substitutions.
U kliničkim ispitivanjima antiretrovirusnog liječenja pomoću pojačanog atazanavira u bolesnika koji prethodno nisu bili liječeni, supstitucija I50L nije se pojavila niti u jednog bolesnika koji na početku nije imao supstituciju za rezistenciju na inhibitore proteaze.
30 hard capsules.
30 tvrdih kapsula.
Dose related asymptomatic prolongations in PR interval with atazanavir have been observed in clinical studies.
U kliničkim je ispitivanjima opaženo asimptomatsko produljenje PR intervala povezano s dozom atazanavira.
Co- administration of atazanavir /ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Ne preporučuje se istovremena primjena atazanavira s ritonavirom i ovih glukokortikoida, osim ako je moguća korist od liječenja veća od rizika od sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
a and at Week 96 (Study 045)
Tablica 6: Ishodi djelotvornosti u 48. tjednu a i 96. tjednu (Ispitivanje 045)
CD4 Mean Change from Baseline, cells/mm All patients
CD4 prosječna promjena od početne vrijednosti, stanice/mm Svi bolesnici
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 atazanavir in randomised controlled and other available clinical trials (n = 2321).
Ove su nuspojave utvrđene u razdoblju nakon stavljanja lijeka u promet, premda, učestalost je procijenjena statističkim izračunom na temelju ukupnog broja bolesnika izloženih atazanaviru u randomiziranim kontroliranim i drugim dostupnim kliničkim ispitivanjima (n = 2321).
This medicine comes in blister packs containing 30 or 30 x 1 (unit dose) capsules or in bottles containing 30 or 90 hard capsules.
Lijek je dostupan u blister pakiranjima koja sadrže 30 kapsula ili 30 x 1 (jedinične doze) kapsulu ili u boci koja sadrži 30 ili 90 tvrdih kapsula.
No significant effect on methadone concentrations was observed.
Nisu opaženi značajni učinci na koncentraciju metadona.
Alternative antiretroviral therapy to Atazanavir Mylan 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.
Co-administration of voriconazole and Atazanavir Mylan with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Ne preporučuje se istovremena primjena vorikonazola i lijeka Atazanavir Mylan s ritonavirom, osim ako procjena omjera koristi i rizika opravdava primjenu vorikonazola.
In case of withdrawal of ritonavir from the recommended atazanavir-boosted regimen (see section 4.4)
Ako se ritonavir izostavi iz preporučenog režima liječenja atazanavirom pojačanim ritonavirom (vidjeti dio 4.4)
Ethinyloestradiol Cmax ↓16% (↓26%
Etinilestradiol Cmax ↓16% (↓26%
(300 mg/100 mg once daily) n=440
(300 mg/100 mg jedanput na dan) n=440
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Mehanizam interakcije je smanjena topljivost atazanavira s povišenjem želučanog pH zbog inhibitora protonske pumpe.
Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) (see section 4.5).
Istodobna primjena s lijekovima koji sadrže grazoprevir, uključujući fiksnu kombinaciju elbasvira/grazoprevira (koja se koristi u liječenju kronične infekcije virusom hepatitisa C) (vidjeti dio
30 x 1 hard capsules.
30 x 1 tvrda kapsula.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI ZA TVRDE KAPSULE
increase in the concentration of these benzodiazepines.
Istovremena primjena atazanavira može jako povećati koncentracije ovih benzodiazepina.
If you stop taking Atazanavir Mylan
Ako prestanete uzimati Atazanavir Mylan
60 hard capsules.
60 tvrdih kapsula.
Co-administration of Atazanavir Mylan with nevirapine or efavirenz is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Mylan s nevirapinom ili efavirenzom (vidjeti dio 4.5).
Efavirenz 600 mg once daily
Efavirenz 600 mg jedanput na dan
Didanosine AUC ↓34% (↓41%
Didanozin AUC ↓34% (↓41% ↓27%)
Elbasvir concentrations were increased when co-administered with atazanavir/ritonavir.
Koncentracije elbasvira bile su povišene s istodobnom primjenom atazanavira/ritonavira.
Nevirapine 200 mg twice daily
Nevirapin 200 mg dvaput na dan
200 mg capsules
200 mg kapsule
Midazolam and triazolam are extensively metabolised by CYP3A4.
Midazolam i triazolam opsežno metabolizira enzim CYP3A4.
Didanosine Cmax ↓38% (↓48%
Didanozin Cmax ↓38% (↓48% ↓26%)
For patients not taking tenofovir, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
300 mg/ritonavir 100 mg primjenjuju istovremeno s antagonistima H2 receptora, ne smije se prekoračiti doza jednaka dozi famotidina od 20 mg dvaput na dan.
300 mg capsules
300 mg kapsule
The co-administration of stavudine with atazanavir is not expected to significantly alter the exposure of stavudine.
Ne očekuje se da će istovremena primjena stavudina i atazanavira značajno promijeniti izloženost stavudinu.
Do not take Atazanavir Mylan
Nemojte uzimati Atazanavir Mylan
Due to phenytoin/phenobarbital inducing effect, a reduction in atazanavir exposure cannot be ruled out combination with atazanavir /ritonavir.
Zbog inducirajućeg učinka fenitoina/fenobarbitala, ne može se isključiti smanjena izloženost atazanaviru.
If you forget to take Atazanavir Mylan
Ako ste zaboravili uzeti Atazanavir Mylan
Each capsule contains 84 mg lactose monohydrate
Jedna kapsula sadrži 84 mg laktoza hidrata 200 mg kapsule
Hyperbilirubinaemia
Hiperbilirubinemija
CD4 Mean Change from Baseline, cells/mm by Baseline Characteristic
CD4 prosječna promjena od početne vrijednosti, stanice/mm prema početnim značajkama
Fluconazole 200 mg once daily
Flukonazol 200 mg jedanput na dan
Patients with coexisting conditions
Bolesnici s drugim istovremeno prisutnim bolestima
Grazoprevir concentrations were greatly increased when co-administered with atazanavir/ritonavir.
Koncentracije grazoprevira značajno su porasle kada je primjenjivan istodobno s atazanavirom/ritonavirom.
ANTI-RETROVIRALS
ANTIRETROVIRUSNI
, toxic skin eruptions a,b drug rash with eosinophilia and systemic symptoms (DRESS) syndrome a,b
, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijekaa,b, medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS)
Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section
Sildenafil je kontraindiciran kad se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
This medicine comes in blister packs containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Lijek je dostupan u blister pakiranjima koja sadrže 30, 60 kapsula ili 60 x 1 (jedinične doze) kapsulu ili u boci koja sadrži 60 tvrdih kapsula.
However, Atazanavir Mylan is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Međutim, Atazanavir Mylan se ne preporučuje u bolesnika na hemodijalizi (vidjeti dijelove 4.2 i 5.2).
Co-administration of voriconazole and atazanavir with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Ne preporučuje se istovremena primjena vorikonazola i atazanavira s ritonavirom osim kad procjena omjera koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dio 4.4).
reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Mehanizam interakcije je smanjenje topljivosti atazanavira s povećanjem pH povezanim s prisutnošću antacida u puferiranim tabletama didanozina.
Each capsule contains 112 mg lactose monohydrate
Jedna kapsula sadrži 112 mg laktoza hidrata 300 mg kapsule
Co-administration of Atazanavir Mylan with proton pump inhibitors is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Mylan s inhibitorima protonske pumpe (vidjeti dio 4.5).
Co-administration of diltiazem and atazanavir /ritonavir has not been studied.
Istovremena primjena diltiazema i atazanavira s ritonavirom nije ispitana.
Atazanavir Mylan is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Atazanavir Mylan je kontraindiciran u bolesnika s teškom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
Concentrations of atazanavir with or without ritonavir are expected to be increased in patients with moderately or severely impaired hepatic function (see sections 4.2, 4.3, and 4.4).
U bolesnika s umjereno do teško oštećenom funkcijom jetre očekuju se povišene koncentracije atazanavira primijenjenog s ritonavirom ili bez njega (vidjeti dijelove 4.2, 4.3 i 4.4).
• chest pain, malaise (generally feeling unwell), fever
• bol u prsištu, malaksalost (opće loše stanje), vrućica
Symptoms of gallbladder problems may include pain in the right or middle upper stomach area, nausea, vomiting, fever or yellowing your skin or the white part of your eyes.
• Manje često mogu se pojaviti problemi sa žučnim kamencima u osoba koje uzimaju lijek Atazanavir Mylan . Simptomi problema sa žučnim kamencima mogu uključivati bol u desnom ili srednjem gornjem dijelu trbuha, mučninu, povraćanje, vrućicu ili žutilo kože ili bjeloočnica.
The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is CYP3A inhibition.
Mehanizam interakcije amiodarona ili sistemskog lidokaina s atazanavirom je inhibicija enzima CYP3A.
• vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion)
• povraćanje, proljev, bol u trbuhu (bol ili nelagoda u želucu), mučnina, dispepsija (probavne tegobe)
This medicine comes in blister packs containing 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Lijek je dostupan u blister pakiranjima koja sadrže 60 kapsula ili 60 x 1 (jedinične doze) kapsulu ili u boci koja sadrži 60 tvrdih kapsula.
For treatment-naive paediatric patients, the mean baseline CD4 cell count was 344 cells/mm
U pedijatrijskih bolesnika koji prethodno nisu bili liječeni, prosječni početni broj CD4 stanica bio je 344 stanice/mm (raspon: 2 do 800 stanica/ mm
ANTIFUNGALS Ketoconazole 200 mg once daily
Ketokonazol 200 mg jedanput na dan
If atazanavir/ritonavir with both tenofovir disoproxil fumarate and an H2-receptor antagonist are co-administered, a dose increase of atazanavir to 400 mg with 100 mg of ritonavir is recommended.
Za bolesnike koji uzimaju tenofovirdizoproksilfumarat, ako se atazanavir /ritonavir primjenjuju istovremeno s tenofovirdizoproksilfumaratom i antagonistom H2 receptora, preporučuje se povišenje doze atazanavira na 400 mg sa 100 mg ritonavira.
* When compared to Atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
* Kad je uspoređivan s atazanavirom 300 mg/ritonavirom 100 mg jedanput na dan, navečer, bez efavirenza.
Atazanavir is metabolised principally by CYP3A4.
Atazanavir uglavnom metabolizira enzim CYP3A4.
HCV Protease Inhibitors Boceprevir 800 mg three times daily
Boceprevir 800 mg triput na dan
Atazanavir is metabolised in the liver through CYP3A4.
Atazanavir se metabolizira u jetri putem enzima CYP3A4.
* When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily.
* Kad se uspoređuje s atazanavirom 300 mg jedanput na dan u kombinaciji s ritonavirom 100 mg jedanput na dan.
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving Atazanavir Mylan should be evaluated for alternative aetiologies.
Potrebno je provjeriti alternativne uzroke povišenja jetrenih transaminaza koje može nastati uz povišenje bilirubina u bolesnika koji primaju Atazanavir Mylan.
using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
Bolesnike treba upozoriti na ove moguće nuspojave kad se inhibitori PDE5 za erektilnu disfunkciju uzimaju istovremeno s atazanavirom (vidjeti dio 4.4).
Mean baseline CD4 cell count was 214 cells/mm
Prosječni broj CD4 stanica na početku iznosio je 214 stanica/mm
uncommon: nephrolithiasis a, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney disease a;
manje često: nefrolitijaza a, hematurija, proteinurija, polakizurija; intersticijalni nefritis; kronična bubrežna bolest a rijetko: bubrežni bolovi
common: ocular icterus
često: ikterus bjeloočnica
Co-administration of salmeterol and Atazanavir Mylan is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena salmeterola i lijeka Atazanavir Mylan (vidjeti dio 4.5).
Omeprazole 20 mg once daily
Famotidin 20 mg dvaput na dan
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900, Mađarska Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Nizozemska
The capsule shell and printing ink contain titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.
Ovojnica kapsule i tinta za označavanje sadrže titanijev dioksid (E171), indigo karmin (E132), žuti željezov oksid (E172), boju patent blue V (E131), želatinu, šelak, propilenglikol, koncentriranu otopinu amonijaka, crni željezov oksid (E172), kalijev hidroksid.
Laboratory abnormalities
abnormalni snovi
Table 1: Dose for paediatric patients (6 to less than 18 years of age and weighing at least 15 kg) for
Tablica 1: Doza Atazanavir Mylan kapsula s ritonavirom za pedijatrijske bolesnike (u dobi od 6 do manje od 18 godina i tjelesne težine od najmanje 15 kg) Tjelesna težina (kg)
Co-administration of atazanavir and indinavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena atazanavira i indinavira (vidjeti dio 4.4).
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
Tijekom praćenja nakon stavljanja lijeka u promet prijavljena je kronična bubrežna bolest u bolesnika zaraženih HIV-om liječenih atazanavirom, sa ili bez ritonavira.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
U osoba s hemofilijom A i B liječenih inhibitorima proteaze zabilježeni su slučajevi pojačanog krvarenja, uključujući spontani nastanak kožnih hematoma i hemartroze.
Titanium dioxide (E171) Patent blue V (E131) Gelatin
Titanijev dioksid (E171) Boja Patent blue V (E131) Želatina
For oral use.
Način primjene Za peroralnu primjenu.
Co-administration of lamotrigine and atazanavir/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Zbog indukcije UGT1A4, istodobna primjena lamotrigina i atazanavira s ritonavirom može sniziti koncentracije lamotrigina u plazmi.
Ethinyloestradiol AUC ↑48%
Etinilestradiol AUC ↑48% (↑31%