natgillin/translations-raw huggingface dataset:
Co-administration with REYATAZ/ritonavir may result in increased concentrations of salmeterol and an increase in salmeterolassociated adverse events.
Istovremena primjena s lijekom REYATAZ/ritonavirom može rezultirati povišenim koncentracijama salmeterola i pojačanim nuspojavama povezanima sa salmeterolom.
REYATAZ 300 mg hard capsules are supplied in bottles of 30 capsules.
REYATAZ 300 mg tvrde kapsule isporučuju se u bočicama sa 30 kapsula.
STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 50 mg of atazanavir (as sulphate).
2. NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 50 mg atazanavira (u obliku atazanavirsulfata)
300 mg (6 sachetsa)
300 mg (6 vrećica a)
REYATAZ/ritonavir may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
REYATAZ/ritonavir može povisiti koncentracije verapamila u serumu zbog inhibicije enzima CYP3A4.
For treatment-naive paediatric patients, the mean baseline CD4 cell count was 930 cells/mm3 (range: 46 to 2291 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.81 log10 copies/ml (range: 3.4 to 5.9 log10 copies/ml).
Za liječenje pedijatrijskih bolesnika koji prethodno nisu bili liječeni srednja početna vrijednost broja CD4 stanica bila je 930 stanica /mm3 (raspon: 46 do 2291 stanica /mm3) srednje početne vrijednosti HIV-1 RNK u plazmi bile su 4,81 log10 kopija /ml (raspon: 3,4 do 5,9 log10 kopija /ml).
Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for REYATAZ capsules with ritonavir Body Weight (kg)
Tablica 1: Doza REYATAZ kapsula s ritonavirom za pedijatrijske bolesnike (u dobi od 6 do manje od 18 godina i tjelesne težine od najmanje 15 kg)
3 x 30 hard capsules: EU/1/03/267/010
3 x 30 tvrdih kapsula: EU/1/03/267/010
The mechanism of interaction is CYP3A4 inhibition by atazanavir/ritonavir.
Mehanizam interakcije je inhibicija enzima CYP3A4 lijekom atazanavirom/ritonavirom
REYATAZ 100 mg hard capsules
REYATAZ 100 mg tvrde kapsule
, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus;
, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka a,b medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS)a,b, angioedema urtikarija, alopecija, pruritus; rijetko: Stevens-Johnsonov sindroma,b, vezikulobulozni osip, ekcem, vazodilatacija
Atazanavir, simultaneous administration with ddI+d4T (fasted) Atazanavir AUC ↓87% (↓92% ↓79%) Atazanavir Cmax ↓89% (↓94% ↓82%) Atazanavir Cmin ↓84% (↓90% ↓73%)
Atazanavir AUC ↓87% (↓92% ↓79%) Atazanavir Cmax ↓89% (↓94% ↓82%) Atazanavir Cmin ↓84% (↓90% ↓73%)
Uncommon (may affect up to 1 in 100 people): peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) hypersensitivity (allergic reaction) asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) alopecia (unusual hair loss or thinning), pruritus (itching)
Manje često (mogu se javiti u do 1 na 100 osoba): periferna neuropatija (utrnulost, slabost, trnci ili bol u rukama i nogama) preosjetljivost (alergijska reakcija) astenija (neobičan umor ili slabost) smanjenje tjelesne težine, povećanje tjelesne težine, anoreksija (gubitak apetita), pojačan apetit depresija, tjeskoba, poremećaj spavanja dezorijentacija, amnezija (gubitak pamćenja), omaglica, somnolencija (izrazita pospanost), abnormalni snovi sinkopa (nesvjestica), hipertenzija (povišeni krvni tlak) otežano disanje (nedostatak zraka) pankreatitis (upala gušterače), gastritis (upala želuca), aftozni stomatitis (ranice u ustima i groznica na usnama), disgeuzija (promjene osjeta okusa), flatulencija (vjetrovi), suha usta, rastezanje trbuha angioedem (teško oticanje kože i drugih tkiva, najčešće usana i očiju) alopecija (neobičan gubitak ili prorijeđenost kose), pruritus (svrbež) mišićna atrofija (gubitak mišića), artralgija (bol u zglobovima), mialgija (bol u mišićima) intersticijalni nefritis (upala bubrega), hematurija (krv u mokraći), proteinurija (višak proteina u mokraći), polakizurija (učestalo mokrenje) ginekomastija (povećanje grudi u muškaraca) bol u prsištu, malaksalost (opće loše stanje), vrućica nesanica (poteškoće sa spavanjem)
triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) simvastatin and lovastatin (used to lower blood cholesterol).
triazolam i peroralni (uzima se kroz usta) midazolam (primjenjuje se za liječenje poremećaja spavanja i/ili ublažavanje tjeskobe) simvastatin i lovastatin (primjenjuju se za snižavanje kolesterola u krvi) lijekovi koji sadrže grazoprevir, ukljućujući fiksnu kombinaciju elbasvir/grazoprevir i fiksnu kombinaciju glekaprevir/pibrentasvir (koja se koristi u liječenju kronične infekcije virusom hepatitisa C)
Co-administration of REYATAZ/ritonavir with proton pump inhibitors is not recommended.
REYATAZ/ritonavira i inhibitora protonske pumpe.
Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Sofosbuvir 400 mg / velpatasvir 100 mg / voksilaprevir 100 mg jedna doza* (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Sofosbuvir 400 mg / velpatasvir 100 mg /voksilaprevir 100 mg jedna doza* (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
REYATAZ with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
REYATAZ s ritonavirom ne smije se primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
HIV RNA <50 copies/ml, % a All patients
HIV RNK <50 kopija/ml, % a Svi bolesnici
The mixture is fed to the infant or young child. An additional tablespoon of food is added to the small container for thorough delivery of the powder from the container and contents are mixed.The entire residual mixture is fed to the child. 3.
Dodatnu jušnu žlicu hrane treba dodati u mali spremnik kako bi se pokupio sav prašak iz spremnika i sadržaj se promiješa.
Atazanavir Cmax ↑18% (↑6.7% ↑31%)* Atazanavir Cmin ↑24 % (↑10% ↑39%)*
Atazanavir AUC ↑18% (↑6.5% Atazanavir Cmax ↑18% (↑6.7% ↑31%)* Atazanavir Cmin ↑24 % (↑10% ↑39%)*
Laboratory abnormalities
Poremećaji laboratorijskih nalaza
Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half.
Neprozirna crvena i plava kapsula s otisnutim "BMS 300 mg" na jednoj polovici i "3622" na drugoj polovici, bijelom tintom.
200 mg (4 sachetsb)
200 mg (4 vrećiceb)
There were fewer treatment discontinuations in the unboosted REYATAZ group (1 vs. 4 subjects in the REYATAZ + ritonavir group).
Zabilježen je manji broj prekida liječenja u skupini liječenoj nepojačanim lijekom REYATAZ (1 naspram 4 ispitanika u skupini koja je primala REYATAZ
Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) Blue ink containing: shellac, propylene glycol, ammonium hydroxide and indigocarmin (E132) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Sadržaj kapsule: krospovidon, laktoza hidrat i magnezijev stearat Ovojnica kapsule: želatina, indigokarmin (E132) i titanijev dioksid (E171) Plava tinta sadrži: šelak, propilenglikol, amonijev hidroksid i indigokarmin (E132) Bijela tinta sadrži: šelak, titanijev dioksid (E171), amonijev hidroksid, propilenglikol i simetikon REYATAZ 200 mg tvrde kapsule
Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena salmeterola i lijeka REYATAZ/ritonavira (vidjeti dio 4.4).
REYATAZ must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4, and 5.2).
REYATAZ se ne smije se primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
Elbasvir 50 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Elbasvir 50 mg jedanput dnevno (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
Tenofovir disoproxil fumarate 300 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Tenofovirdizoproksilfumarat 300 mg jedanput na dan (atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Nevirapine 200 mg twice daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Nevirapin 200 mg dvaput na dan (atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Opaque blue capsule printed with white ink, with "BMS 200 mg" on one half and with "3631" on the other half.
Neprozirna plava kapsula s otisnutim "BMS 200 mg" na jednoj polovici i "3631" na drugoj polovici, bijelom tintom.
REYATAZ 300 mg hard capsules
REYATAZ 300 mg tvrde kapsule
CD4 Mean Change from Baseline, cells/mm3 by Baseline Characteristic HIV RNA <100,000 copies/ml
290 (n=317) CD4 prosječna promjena od početne vrijednosti, stanice/mm3 prema početnim značajkama HIV RNK <100 000 kopija/ml
The mechanism of interaction is CYP3A4 inhibition by REYATAZ and/or ritonavir.
Mehanizam interakcije je inhibicija enzima CYP3A4 lijekom REYATAZ i/ili ritonavirom.
Renal impairment: No dosage adjustment is needed in patients with renal impairment.
Oštećenje funkcije bubrega: U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze.
30 hard capsules: EU/1/03/267/008
30 tvrdih kapsula: EU/1/03/267/008
INFORMATION IN BRAILLE Outer carton: REYATAZ 50 mg
16. PODACI NA BRAILLEOVOM PISMU Kutija: REYATAZ 50 mg
Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Rifabutin 150 mg dvaput tjedno (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
Co-administration of voriconazole and REYATAZ 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 lijeka REYATAZ s ritonavirom osim kad procjena omjera koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dio 4.4).
Add a minimum of one tablespoon of food and mix.
Napunite mali spremnik sadržajem vrećica 2. Dodajte najmanje jednu jušnu žlicu hrane i promiješajte.
Larger volumes or quantities of liquid infant formula, beverage or food may be used for dosing.
Za doziranje se mogu primijeniti i veći volumeni ili količine tekuće dojenačke formule, pića ili hrane Pobrinite se da je uzeta sva količina dojenačke formule, pića ili hrane koja sadrži lijek
REYATAZ 150 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
REYATAZ 150 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 60 kapsula.
REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 150 mg tvrde kapsule isporučuju se u bocama sa 60 kapsula.
Omeprazole 20 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Omeprazol 20 mg jedanput na dan (atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
REYATAZ with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Primjena lijeka REYATAZ u kombinaciji s ritonavirom kontraindicirana je u bolesnika s umjerenom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
REYATAZ 300 mg hard capsules are also supplied in blister strips in packs of 30 capsules.
REYATAZ 300 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 30 kapsula.
Co-administration of REYATAZ with products containing St. John's wort is contraindicated.
Istovremena primjena lijeka REYATAZ i proizvoda koji sadrže gospinu travu je kontraindicirana.
Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovi 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.
U odraslih bolesnika koji su prethodno bili liječeni antiretrovirusnim lijekovima Ispitivanje 045 randomizirano je, multicentrično ispitivanje u kojem su REYATAZ/ritonavir (300/100 mg jedanput na dan) i REYATAZ/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 Prosječno trajanje prethodne izloženosti randomiziranih bolesnika antiretrovirusnim lijekovima iznosilo je 138 tjedana za inhibitore proteaze, 281 tjedana za NRTI-jeve i 85 tjedana za NNRTI-jeve.
Famotidine 40 mg twice daily Atazanavir AUC ↓23% (↓32% ↓14%) Atazanavir Cmax ↓23% (↓33% ↓12%) Atazanavir Cmin ↓20% (↓31% ↓8%) In Healthy volunteers with atazanavir/ritonavir at an increased dose of 400/100 mg once daily Famotidine 40 mg twice daily Atazanavir AUC ↔3% (↓14% ↑22%) Atazanavir Cmax ↔2% (↓13% ↑8%) Atazanavir Cmin ↓14% (↓32% ↑8%)
Atazanavir AUC ↓23% (↓32% ↓14%) Atazanavir Cmax ↓23% (↓33% ↓12%) Atazanavir Cmin ↓20% (↓31% ↓8%) Primjena atazanavira/ritonavira u povišenoj dozi od 400/100 mg jedanput na dan u zdravih dobrovoljaca
How to store REYATAZ
Kako čuvati REYATAZ
Co-administration of salmeterol and REYATAZ is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena salmeterola i lijeka REYATAZ (vidjeti dio 4.5).
HIV RNA <50 copies/ml by select baseline PI substitutions,f, g % (responder/evaluable) NA
NP HIV RNK <50 kopija/ml prema odabranim supstitucijama za rezistenciju na inhibitor proteaze na početku ispitivanja,f, g % bolesnici s odgovorom/bolesnici koji su se mogli procijeniti) NP
REYATAZ 150 mg hard capsules atazanavir
REYATAZ 150 mg tvrde kapsule atazanavir
REYATAZ 200 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 200 mg tvrde kapsule isporučuju se u bočicama sa 60 kapsula.
30 hard capsules: EU/1/03/267/009
30 tvrdih kapsula: EU/1/03/267/009
uncommon: hypersensitivity
Poremećaji imunološkog sustava: manje često: preosjetljivost
other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) if you are taking an oral contraceptive ("the Pill") with REYATAZ to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking REYATAZ or 2 hours after taking REYATAZ, H2-blockers like famotidine and proton pump inhibitors like omeprazole) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil) atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) irinotecan (used to treat cancer) sedative agents (e.g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
druge lijekove za liječenje HIV-infekcije (npr. indinavir, nevirapin i efavirenz) boceprevir i sofusbuvir/velpatasvir/voksilaprevir (koji se koriste u liječenju hepatitisa C) sildenafil, vardenafil ili tadalafil (uzimaju ga muškarci za liječenje impotencije (erektilna disfunkcija) ako uzimate oralnu kontracepciju ("pilule") s lijekom REYATAZ, za sprečavanje trudnoće, pazite da je uzimate točno prema uputama liječnika i da ne propustite niti jednu dozu bilo koje lijekove za liječenje bolesti povezanih s kiselinom u želucu (npr., antacide, koji se moraju uzeti barem 1 sat prije uzimanja lijeka REYATAZ, ili 2 sata nakon uzimanja lijeka REYATAZ, H2-blokatore kao famotidin ili inhibitore protonske pumpe kao omeprazol) lijekove za snižavanje krvnog tlaka, usporavanje rada srca ili ispravljanje srčanog ritma (amiodaron, diltiazem, sistemski lidokain, verapamil) atorvastatin, pravastatin i fluvastatin (primjenjuju se za snižavanje kolesterola u krvi) salmeterol (primjenjuje se za liječenje astme) ciklosporin, takrolimus i sirolimus (lijekovi za sniženje učinaka imunološkog sustava tijela) određene antibiotike (rifabutin, klaritromicin) ketokonazol, itrakonazol i vorikonazol (antimikotici) varfarin (antikoagulans, primjenjuje se za smanjenje zgrušavanja krvi) karbamazepin, fenitoin, fenobarbital, lamotrigin (antiepileptici) irinotekan (primjenjuje se u liječenju raka) sedative (npr. midazolam primijenjen injekcijom) buprenorfin (primjenjuje se za liječenje ovisnosti o opijatima i boli).
Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Sadržaj kapsule: krospovidon, laktoza hidrat i magnezijev stearat Ovojnica kapsule: želatina, indigokarmin (E132) i titanijev dioksid (E171) Bijela tinta sadrži: šelak, titanijev dioksid (E171), amonijev hidroksid, propilenglikol i simetikon REYATAZ 300 mg tvrde kapsule
Fluconazole 200 mg once daily (atazanavir 300 mg and ritonavir 100 mg once daily)
Flukonazol 200 mg jedanput na dan (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
INFORMATION IN BRAILLE Outer carton: REYATAZ 300 mg
16. PODACI NA BRAILLEOVOM PISMU Kutija: REYATAZ 300 mg
Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.
Neprozirna plava i sivoplava kapsula s otisnutim "BMS 150 mg" na jednoj polovici i "3624" na drugoj polovici plavom i bijelom tintom.
Each sachet contains 50 mg of atazanavir (as sulphate).
Jedna vrećica sadrži 50 mg atazanavira (u obliku atazanavirsulfata).
INFORMATION IN BRAILLE Outer carton: REYATAZ 100 mg
16. PODACI NA BRAILLEOVOM PISMU Kutija: REYATAZ 100 mg
uncommon: nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain
manje često: nefrolitijazaa, hematurija, proteinurija, polakizurija; intersticijalni nefritis;kronična bubrežna bolesta; rijetko: bubrežni bolovi
Co-administration of REYATAZ with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Istodobna primjena lijeka REYATAZ s glekaprevir/pibrentasvirom kontraindicirana je jer postoji rizik povišenja vrijednosti ALTa zbog značajnog povećanja koncentracije glekaprevira i pibrentasvira u plazmi (vidjeti dio 4.3).
It is especially important to mention these: other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) if you are taking an oral contraceptive ("the Pill") with REYATAZ to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking REYATAZ or 2 hours after taking REYATAZ, H2-blockers like famotidine and proton pump inhibitors like omeprazole) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil) atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) irinotecan (used to treat cancer) sedative agents (e.g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Osobito je važno da spomenete sljedeće: druge lijekove za liječenje HIV-infekcije (npr. indinavir, nevirapin i efavirenz) boceprevir i sofusbuvir/velpatasvir/voksilaprevir (koji se koriste u liječenju hepatitisa C) sildenafil, vardenafil ili tadalafil (uzimaju ga muškarci za liječenje impotencije (erektilna disfunkcija) ako uzimate oralnu kontracepciju ("pilule") s lijekom REYATAZ, za sprečavanje trudnoće, pazite da je uzimate točno prema uputama liječnika i da ne propustite niti jednu dozu bilo koje lijekove za liječenje bolesti povezanih s kiselinom u želucu (npr., antacide, koji se moraju uzeti barem 1 sat prije uzimanja lijeka REYATAZ, ili 2 sata nakon uzimanja lijeka REYATAZ, H2-blokatore kao famotidin ili inhibitore protonske pumpe kao omeprazol) lijekove za snižavanje krvnog tlaka, usporavanje rada srca ili ispravljanje srčanog ritma (amiodaron, diltiazem, sistemski lidokain, verapamil) atorvastatin, pravastatin i fluvastatin (primjenjuju se za snižavanje kolesterola u krvi) salmeterol (primjenjuje se za liječenje astme) ciklosporin, takrolimus i sirolimus (lijekovi za sniženje učinaka imunološkog sustava tijela) određene antibiotike (rifabutin, klaritromicin) ketokonazol, itrakonazol i vorikonazol (antimikotici) varfarin (antikoagulans, primjenjuje se za smanjenje zgrušavanja krvi) karbamazepin, fenitoin, fenobarbital, lamotrigin (antiepileptici) irinotekan (primjenjuje se u liječenju raka) sedative (npr. midazolam primijenjen injekcijom) buprenorfin (primjenjuje se za liječenje ovisnosti o opijatima i boli).
Famotidine 20 mg twice daily Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
Atazanavir AUC ↓21% (↓34% ↓4%) * Atazanavir Cmax ↓21% (↓36% ↓4%) * Atazanavir Cmin ↓19% (↓37% ↑5%) *
REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
REYATAZ 200 mg tvrde kapsule isporučuju se i u blisterima u pakiranjima sa 60 kapsula.
s r.o.
+ ritonavir.
Co-administration of nevirapine with REYATAZ/ritonavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena nevirapina i lijeka REYATAZ/ritonavira (vidjeti dio 4.4)
REYATAZ 200 mg hard capsules
REYATAZ 200 mg tvrde kapsule
Famotidine 40 mg twice daily Atazanavir AUC ↓24% (↓36% ↓11%)* Atazanavir Cmax ↓23% (↓36% ↓8%) * Atazanavir Cmin ↓25% (↓47% ↑7%) *
Atazanavir AUC ↓24% (↓36% ↓11%)* Atazanavir Cmax ↓23% (↓36% ↓8%) * Atazanavir Cmin ↓25% (↓47% ↑7%) *
NAME OF THE MEDICINAL PRODUCT REYATAZ 150 mg hard capsules atazanavir
NAZIV LIJEKA REYATAZ 150 mg tvrde kapsule atazanavir
Co-administration of nevirapine and REYATAZ is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena nevirapina i lijeka REYATAZ (vidjeti dio 4.4)
Co-administration of REYATAZ/ritonavir with alfuzosin is contraindicated (see section 4.3)
Istovremena primjena alfuzosina i lijeka REYATAZ/ritonavira je kontraindicirana (vidjeti dio 4.3)