natgillin/translations-raw huggingface dataset:
↑ 1.15 ↑ 1.34 ↑ 1.13
(atazanavir 400 mg 1x/ dan)
A rifabutin dose
(0, 98; 1, 34)
(atazanavir 400 mg QD)
(1, 14; 1, 59)
atazanavir (0.98, 1.34) (1.14, 1.59) (0.68, 1.87)
(0, 68; 1, 87)
reduction of up to 75% (eg, 150 mg every
REYATAZ / ritonavirja priporočamo, da se
Rifabutin 150 mg QD
Rifabutin 150 mg 1x/ dan
↑ 2.10 ↑ 1.18 ↑ 3.43 rifabutin
rifabutin
other day or 3 times
odmerek rifabutina
(atazanavir 600 mg QD) This is not the recommended therapeutic dose of atazanavir.
(atazanavir 600 mg 1x/ dan)
The mechanism of rifabutin and atazanavir interaction is CYP3A4 inhibition
To ni priporočeni terapevtski
per week) is recommended when rifabutin is administered with REYATAZ/ ritonavir.
↑ 75, 6 *
Rifampicin ACID REDUCING AGENTS H2-Receptor antagonists
150 mg vsak
During attempts to overcome the decreased exposure by increasing the dose of REYATAZ or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
odmerek atazanavirja.
The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
rifabutin
Famotidine 40 mg BID
(15, 97; 30, 34)
↓ 0.82 ↓ 0.86 ↓ 0.72 atazanavir
(5, 90; 11, 40)
No dosage adjustment
(30, 1; 190, 0)
(atazanavir 300 mg QD with ritonavir 100 mg QD)
drugi dan ali 3- krat na
(0.75, 0.89) (0.79, 0.94) (0.64, 0.81) Although not studied, similar results are expected with other H2-receptor antagonists.
* Pri primerjavi z rifabutinom 300 mg 1x/ dan. teden).
The relevance of these data for HIV infected patients is unknown since the intragastric pH may be higher in this population.
Rifampicin
Therefore, the magnitude of this effect may be more pronounced.
Rifampicin je močan induktor CYP3A4.
The mechanism of interaction is decreased solubility of atazanavir as intra- gastric pH increases with H2 blockers.
Dokazano je bilo, da se vrednosti AUC atazanavirja zmanjšajo za 72%.
of REYATAZ/ ritonavir is required when co-administered with an H2-receptor antagonist, all as a single daily dose with food.
Posledica tega je lahko upad protivirusnega delovanja in razvoj rezistence.
Reductions in atazanavir concentrations may be avoided by temporal separation of REYATAZ and an H2-receptor antagonist as follows:
Ko so manjšo izpostavljenost poskušali nadomestiti z zvečanjem odmerka zdravila REYATAZ ali drugih zaviralcev proteaz v kombinaciji z ritonavirjem, so poročali o večji pogostnosti jetrnih neželenih učinkov.
REYATAZ 300 mg with ritonavir 100 mg once daily with food, 2 hours before and at least 10 hours
Sočasna uporaba rifampicina in zdravila REYATAZ skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte
concerning
atazanavir
co-administration
Pri sočasni uporabi
following the administration of an H2-receptor antagonist.
(atazanavir 300 mg 1x/ dan z ritonavirjem 100 mg 1x/ dan)
Proton pump inhibitors Omeprazole 40 mg QD
(0, 79; 0, 94)
atazanavir (am):
(0, 64; 0, 81)
2
H2.
(atazanavir 400 mg QD with
(atazanavir 400 mg 1x/ dan z
REYATAZ/ ritonavir
zdravila REYATAZ /
ritonavir 100 mg QD)
2 uri ritonavirjem 100 mg 1x/ dan) Omeprazol 20 mg 1x/ dan
omeprazole
po omeprazolu
(0.35, 0.45)
(0, 35; 0, 45)
(0.38, 0.51)
(0, 38; 0, 51)
(0.29, 0.41)
(0, 29; 0, 41)
with proton pump inhibitors is not recommended.
ritonavirja in zaviralcev protonske črpalke ne priporočamo.
combination of
atazanavir
1
uporaba zdravila
hr after
↓ 0, 70 *
↓ 0.70*
↓ 0, 69 *
↓ 0.69*
↓ 0, 69 *
↓ 0.69*
(dopoldan):
with a proton pump
REYATAZ / ritonavirja
ritonavir 100 mg QD)
ritonavirjem 100 mg 1x/ dan)
omeprazaole
po omeprazolu
(0.57, 0.86)
(0, 57; 0, 86)
(0.58, 0.83)
(0, 58; 0, 83)
(0.54, 0.88)
(0, 54; 0, 88)
unavoidable, close clinical monitoring is
z zaviralcem protonske črpalke nujna, je
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.
* Pri primerjavi z atazanavirjem 300 mg 1x/ dan z ritonavirjem 100 mg potreben skrben 1x/ dan. klinični nadzor, odmerek zdravila Če so povečan odmerek zdravila REYATAZ/ ritonavirja (400/ 100 mg REYATAZ pa je treba enkrat na dan) začasno ločili od uporabe omeprazola za 12 ur, se povečati na 400 mg in zmanjšanje vrednosti AUC, Cmax, in Cmin ni ublažilo.
This decrease in atazanavir exposure might negatively impact the efficacy of atazanavir.
Študije sicer niso ga uporabljati skupaj z bile izvedene, vendar pa podobne rezultate pričakujemo tudi pri uporabi ritonavirjem v drugih zaviralcev protonske črpalke.
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
To zmanjšanje izpostavljenosti odmerku 100 mg. atazanavirju lahko vpliva negativno na učinkovitost atazanavirja.
recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
(glejte poglavje 4. 4).
Antacids and medicinal products containing buffers ANTICOAGULANTS
Antacidi Antacidi in zdravila, ki vsebujejo pufre
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ/ ritonavir.
Zaradi zvišanja vrednosti pH želodčne vsebine zaradi uporabe antacidov, vključno z zdravili, ki vsebujejo pufre se lahko zmanjšajo
REYATAZ/ ritonavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Zdravilo REYATAZ / ritonavir je treba
Warfarin
Sočasno uporabljena
Co-administration with REYATAZ/ ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Vrednoteno
It is recommended that the INR be monitored carefully during treatment with REYATAZ/ ritonavir, especially when commencing therapy.
AUC
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Irinotecan Immunosuppressants
Cmax
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Cmin
If REYATAZ/ ritonavir is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Priporočila za
Cyclosporin Tacrolimus Sirolimus CARDIOVASCULAR AGENTS Antiarrhythmics
zdravila (odmerek v mg)
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ ritonavir due to CYP3A4 inhibition.
zdravilo
More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised.
(90% IZ) (90% IZ) (90% IZ)
Amiodarone, Systemic lidocaine, Quinidine
sočasno uporabo
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ/ ritonavir.
koncentracije atazanavirja.
Caution is warranted and therapeutic concentration monitoring is
uporabljati 2 uri pred ali 1 uro po uporabi antacida ali zdravila, ki vsebuje pufer.
9
Varfarin
Co-administered medicinal
Pri sočasni uporabi zdravila REYATAZ / ritonavirja se lahko vrednost INR (internacionalno normalizirano razmerje) zmanjša, v redkejših primerih pa tudi poveča.
Medicinal
Med zdravljenjem z zdravilom REYATAZ / ritonavirjem priporočamo skrben nadzor vrednosti INR, še posebej ob uvedbi zdravljenja.
AUC
ZDRAVILA Z DELOVANJEM NA NOVOTVORBE IN IMUNOSUPRESIVI Zdravila z delovanjem na novotvorbe Irinotekan Imunosupresivi
Cmax
Atazanavir zavira UGT in lahko vpliva na presnovo irinotekana, pri čemer toksičnost irinotekana lahko poveča.
Cmin
Če se zdravilo REYATAZ / ritonavir uporablja skupaj z irinotekanom, je bolnika treba skrbno nadzirati glede pojava neželenih učinkov irinotekana.
Recommendations
Ciklosporin Takrolimus Sirolimus
products (dose in mg)
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se zaradi zavrtja CYP3A4 lahko koncentracije teh imunosupresivov lahko povečajo.
product assessed
Priporočamo pogostejše spremljanje terapevtskih koncentracij teh zdravil, dokler se plazemske vrednosti ne ustalijo.
(90% CI) (90% CI) (90% CI)
ZDRAVILA ZA BOLEZNI SRCA Antiaritmiki
concerning
IN OŽILJA
Calcium channel blockers
Amiodaron, Lidokain za sistemsko uporabo, Kinidin Zaviralci kalcijevih kanalčkov
contraindicated due to potential inhibition of CYP3A by REYATAZ/ ritonavir.
Kinidin ima ozko terapevtsko okno, njegova uporaba pa je kontraindicirana zaradi možne inhibicije CYP3A z zdravilom REYATAZ / ritonavirjem.
recommended when available.
Potrebna je previdnost.
The concomitant use of quinidine is contraindicated (see section 4.3).
Sočasna uporaba kinidina je kontraindicirana (glejte poglavje 4. 3).
REYATAZ/ ritonavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Zdravila REYATAZ / ritonavirja se ne sme uporabljati skupaj z zdravili, ki so substrat za CYP3A4 in imajo ozki terapevtski indeks.
Co-administration with bepridil is contraindicated (see section 4.3)
Sočasna uporaba bepridila je kontraindicirana (glejte poglavje 4. 3).
Diltiazem 180 mg QD
Diltiazem 180 mg 1x/ dan
↑ 2.25 ↑ 1.98 ↑ 2.42 diltiazem
↑ 2, 42
An initial dose
Priporočamo začetno
(2.09, 2.41 (1.78, 2.19) (2.14, 2.73) desacetyl- ↑ 2.65 ↑ 2.72 ↑ 2.21 diltiazem (2.45, 2.87) (2.44, 3.03) (2.02, 2.42)
(2, 14; 2, 73)
reduction of diltiazem by 50% is recommended, with subsequent titration as
zmanjšanje odmerka diltiazema za 50% ter
No significant effect on atazanavir concentrations was observed.
desacetil- diltiazem
There was an increase in the maximum PR interval compared to atazanavir alone.
↑ 2, 21
needed and ECG monitoring
kasnejše povečevanje
Verapamil CORTICOSTEROIDS
(2, 45; 2, 87)
Serum concentrations of verapamil may be increased by REYATAZ/ ritonavir due to CYP3A4 inhibition..
(2, 44; 3, 03)
Caution should be exercised when verapamil is co-administered with REYATAZ/ ritonavir
(2, 02; 2, 42)
Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules BID) ERECTILE DYSUNCTION PDE5 Inhibitors
odmerka v skladu s spremljanjem EKG.
The effects of high fluticasone systemic exposure on ritonavir plasma levels are yet unknown.
Pomembnih učinkov na koncentracije atazanavirja niso opazili.
The mechanism of interaction is CYP3A4 inhibition.
V primerjavi z uporabo atazanavirja samega so poročali o podaljšanju najdaljšega PR intervala.
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).
Sočasne uporabe diltiazema in zdravila REYATAZ / ritonavirja niso raziskovali.
Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
Mehanizem interakcije diltiazem/ atazanavir je inhibicija CYP3A4.
Sildenafil
Verapamil KORTIKOSTEROIDI
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.
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se lahko serumske koncentracije verapamila povečajo zaradi inhibicije CYP3A4..
Patients should be warned about these possible side effects.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja in verapamila je potrebna previdnost.
HERBAL PRODUCTS
Flutikazonpropionat za
John's wort with REYATAZ/ ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Plazemske vrednosti flutikazonpropionata so se znatno povečale,
Co-administration of REYATAZ/ ritonavir
Sočasne uporabe
Medicinal
Vrednoteno AUC Cmax Cmin
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
intranazalno uporabo 50 µg 4 krat na dan, 7 dni (ritonavir 100 mg kapsule 2x/ dan) ZDRAVILA ZA ZDRAVLJENJE EREKTILNE DISFUNKCIJE Zaviralci PDE5
John's wort is contraindicated.
intrinzične vrednosti kortizola pa zmanjšale za približno 86% (90% interval zaupanja; 82- 89%).
Ethinyloestradiol 35 μ g + norethindrone (atazanavir 400
Večje učinke lahko pričakujemo pri uporabi inhalacijskih oblik flutikazonpropionata.
The concentration of oral contraceptives was increased due to UGT inhibition.
Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo.
In contrast, ritonavir may decrease ethinyloestradiol concentrations.
Omenjeni sistemski kortikosteroidni učinki se lahko pojavijo tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo s P450 3A, npr. budezonid.
The effects of co-administration of oral contraceptives and REYATAZ/ ritonavir have not been studied.
Učinki visoke sistemske izpostavljenosti flutikazonu na vrednosti ritonavirja v plazmi trenutno še niso znani.
Alternate reliable methods of contraception should be considered.
Mehanizem interakcije je inhibicija CYP3A4.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ/ ritonavir may result in increased concentrations.
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).
Co-administration of simvastatin or lovastatin with REYATAZ/ ritonavir is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Razmisliti je treba o zmanjšanju odmerka glukokortikoida in skrbno nadzirati morebiten pojav lokalnih ali sistemskih učinkov ali glukokortikoid zamenjati s takšnim, ki ni substrat za CYP3A4 (npr. beklometazon).
The use of another HMG- CoA reductase inhibitor which does not undergo metabolism by CYP3A such as pravastatin or fluvastatin is recommended.
V primeru prekinitve zdravljenja z glukokortikoidom bo morda treba odmerek zmanjševati postopoma daljši čas.
Atorvastatin OPIOIDS
Sildenafil
The risk of myopathy including rhabdomyolysis may also be increased with atorvastatin, which is also metabolised by CYP3A4.
Pri sočasni uporabi z zdravilom REYATAZ/ ritonavirjem se lahko koncentracije sildenafila povečajo in pojavijo neželeni učinki sildenafila, kot so hipotenzija, spremembe vida in priapizem.
Caution should be exercised.
Bolnike je treba opozoriti na te možne neželene učinke.
Buprenorphine, QD, stable maintenance dose,
PRIPRAVKI RASTLINSKEGA IZVORA
buprenorphine ↑ 1.67 ↑ 1.37 ↑ 1.69
Šentjanževka (Hypericum perforatum):
Co-administration warrants
HORMONSKI KONTRACEPTIVI
(atazanavir 300 mg QD with ritonavir 100 mg QD)
Pri sočasni uporabi šentjanževke in zdravila REYATAZ/ ritonavirja lahko pričakujemo pomembno zmanjšanje plazemskih vrednosti atazanavirja.
norbuprenorphine ↑ 2.05 ↑ 1.61 ↑ 2.01 The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Ta učinek je lahko posledica indukcije CYP3A4.
Concentrations of atazanavir were not significantly affected.
Obstaja tveganje za izgubo terapevtskega učinka in razvoj odpornosti (glejte poglavje 4. 3).
A dose reduction of buprenorphine may be considered
Sočasna uporaba zdravila REYATAZ/ ritonavirja in pripravkov s šentjanževko je kontraindicirana.
Methadone, stable maintenance dose (atazanavir 400 mg QD) SEDATIVES Benzodiazepines
Etinilestradiol 35 μg + noretindron (atazanavir 400 mg 1x/ dan)
No significant effect on methadone concentrations was observed.
Sočasni uporabi zdravila REYATAZ/ ritonavirja
No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir.
Zaradi zaviranja UGT so se koncentracije peroralnih kontraceptivov in peroralnih povečale.
Midazolam and triazolam are extensively metabolized by CYP3A4.
Nasprotno po lahko ritonavir zmanjša koncentracije kontraceptivov se je etinilestradiola.
Co-administration with REYATAZ/ ritonavir may cause a large increase in the concentration of these benzodiazepines.
Učinka sočasne uporabe peroralnih kontraceptivov in treba izogibati (glejte zdravila REYATAZ/ ritonavirja niso raziskovali. poglavje 4. 4).
No drug interaction study has been performed for the co-administration of REYATAZ/ ritonavir with benzodiazepines.
ZDRAVILA ZA ZMNAJŠANJE RAVNI LIPIDOV Zaviralci reduktaze HMG- CoA Simvastatin Lovastatin
Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Presnova simvastatina in lovastatina je močno odvisna od CYP3A4.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Pri sočasni uporabi zdravila REYATAZ/ ritonavirja se lahko koncentracije povečajo.
If REYATAZ is
Sočasna uporaba simvastatina ali lovastatina z zdravilom REYATAZ / ritonavirjem ni
concerning
sočasno uporabo
co-administration
Pri sočasni uporabi je potreben klinični nadzor sedacije in
co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/ or prolonged sedation.
Če se zdravilo REYATAZ uporablja skupaj s parenteralnim midazolamom, ga je treba uporabljati v enoti za intenzivno nego ali podobnih okoliščinah, ki zagotavljajo skrben klinični nadzor in možnost ustreznega zdravniškega ukrepanja v primeru pojava zavore dihanja in/ ali podaljšane sedacije.
4.6 Pregnancy and lactation
12 4. 6 Nosečnost in dojenje
There are no adequate data from the use of atazanavir in pregnant women.
Ni zadostnih podatkov o uporabi atazanavirja pri nosečnicah.
Studies in animals have not shown evidence of selective developmental toxicity or effects on reproductive function and fertility (see section 5.3).
Študije na živalih niso pokazale selektivne razvojne toksičnosti ali vplivov na sposobnost razmnoževanja in plodnost (glejte poglavje 5. 3).
REYATAZ should be used during pregnancy only if the potential benefit justifies the potential risk.
Med nosečnostjo se sme zdravilo REYATAZ uporabljati le, če možne koristi upravičujejo možna tveganja.
In the prepartum period, additional monitoring and alternative therapy to REYATAZ should be considered.
V predporodnem obdobju je potrebno dodatno nadziranje in razmisliti je treba o alternativnem zdravljenju namesto uporabe zdravila REYATAZ.
It is not known whether atazanavir is excreted in human milk.
Ni znano, ali se atazanavir izloča v materino mleko.
It is therefore recommended that mothers being treated with REYATAZ not breast-feed their infants.
Zato je priporočljivo, da matere, ki jemljejo zdravilo REYATAZ, ne dojijo.
As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV.
Tudi na splošno je priporočljivo, da ženske, okužene z virusom HIV, ne dojijo, da ne bi prišlo do prenosa virusa HIV.
Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
Bolnike je treba opozoriti, da so med zdravljenjem s shemami, ki so vsebovale zdravilo REYATAZ, poročali o omotici (glejte poglavje 4. 8).
REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 48 weeks median duration and 101 weeks maximum duration).
Varnost zdravila REYATAZ so ocenili v sklopu kombiniranega zdravljenja z drugimi protiretrovirusnimi zdravili v nadzorovanih kliničnih preskušanjih pri 1. 806 odraslih bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 400 mg enkrat na dan (1. 151 bolnikov, mediani čas zdravljenja 52 tednov, najdaljši čas zdravljenja 152 tednov) ali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan (655 bolnikov, mediani čas zdravljenja 48 tednov, najdaljši čas zdravljenja 101 teden).
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.
Izjema sta bila le zlatenica in zvišanje vrednosti celotnega bilirubina, ki sta bila pri uporabi zdravila REYATAZ skupaj z ritonavirjem pogostejša.
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 (12%).
Pri bolnikih, ki so prejemali zdravilo REYATAZv odmerku 400 mg enkrat na dan ali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, so bili kot zelo pogosti opisani le naslednji neželeni učinki vseh jakosti, ki bi vsaj lahko bili povezani z uporabo zdravila REYATAZ v kombinaciji z enim nukleozidnim/ nukleotidnim zaviralcem reverzne transkriptaze (NRTI) ali več: navzea (20%), driska (10%) in zlatenica (12%).
Among patients receiving REYATAZ 300 mg with ritonavir
Pri bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg, je bila pogostnost zlatenice 17%.
In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
V večini primerov se je zlatenica pojavila v nekaj dneh do nekaj mesecih po uvedbi zdravljenja (glejte poglavje 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy, and dorsocervical fat accumulation (buffalo hump).
Kombinirano protiretrovirusno zdravljenje je bilo pri bolnikih s HIV povezano s prerazporeditvijo telesnega maščevja (lipodistrofija), vključno z izgubljanjem perifernega in obraznega podkožnega maščevja, kopičenjem intraabdominalnega in visceralnega maščevja, hipertrofijo dojk in dorzocervikalnim kopičenjem maščevja (bivolja grba).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, and hyperlactataemia (see sections 4.4 and 5.1).
Kombinirano protiretrovirusno zdravljenje je bil povezano s presnovnimi motnjami, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in hiperlaktatemija (glejte poglavji 4. 4 in 5. 1).
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.
13 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.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), or very rare (< 1/ 10,000).
Pogostost naštetih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000) ali zelo redki (< 1/ 10. 000).
Nervous system disorders:
redki: edem, palpitacije Srčne bolezni:
Respiratory, thoracic and mediastinal disorders:
pogosti: glavobol; Bolezni živčevja: občasni: periferna nevropatija, sinkopa, amnezija, omotica, somnolenca, paragevzija
Gastrointestinal disorders:
pogosti: očesni ikterus Očesne bolezni: