natgillin/translations-raw huggingface dataset:
Effects on drug levels Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
atazanavir (popoldne):
Recommendation concerning co-administration with efavirenz
odmerka ritonavira na 200 mg ob
Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 200 mg once daily/ 600 mg once daily, all administered with food)
(400 mg enkrat na dan/ 200 mg enkrat
Atazanavir (pm):
AUC: ↔ * / ** (↓ 10% do
This decrease in atazanavir Cmin might negatively
skrbem kliničnem spremljanju.
the dose of both atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
na dan/ 600 mg enkrat na dan, vse se vzame s hrano)
impact the efficacy of atazanavir. ** based on historical comparison
To zmanjšanje v Cmin atazanavira lahko negativno vpliva na učinkovitost atazanavira. ** temelji na pretekli primerjavi
Similar findings are expected with the approved darunavir/ ritonavir
Podobne ugotovitve pričakujemo za odobren odmerek darunavir/ ritonavir 600/ 100 mg
600/ 100 mg twice daily dose.
dvakrat na dan.
Indinavir/ Efavirenz (800 mg q8h/ 200 mg once daily)
(800 mg q8h/ 200 mg enkrat na dan)
Indinavir:
AUC: ↓ 31% (↓ 8 do ↓ 47)
AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40% A similar reduction in indinavir exposures was observed when indinavir 1.000 mg q8h was given with efavirenz 600 mg daily.
Cmin: ↓ 40% Pri jemanju indinavira 1000 mg q8h z efavirenzem 600 mg na dan so opazili podobno zmanjšanje v izpostavljenosti indinaviru.
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.
ugotovili, vendar je treba stopnjo opažene farmakokinetične interakcije upoštevati pri izbiri režima zdravljenja, pri katerem se uporabljata oba – efavirenz in indinavir.
Efavirenz:
Učinki na koncentracije
No dosage adjustment is necessary for efavirenz when given with indinavir or indinavir/ ritonavir.
Priporočilo glede sočasne
79 Medicinal product by therapeutic
terapevtskih področjih
co-administration with efavirenz
Ni klinično pomembnih farmakokinetičnih interakcij.
Indinavir/ ritonavir/ Efavirenz
Pri jemanju z indinavirom ali indinavirom/ ritonavirom indinavir/ ritonavir/ efavirenz (800 mg dvakrat na dan/ 100 mg
(800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
dvakrat na dan/ 600 mg enkrat na dan)
AUC: ↓ 25% (↓ 16 to ↓ 32) b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b Efavirenz:
Ni klinično pomembnih farmakokinetičnih interakcij.
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/ ~6.5 ml
Pri sočasni uporabi z efavirenzem je potrebno razmisliti o zvišanju odmerka lopinavir/ ritonavir mehkih kapsul ali peroralne
twice daily instead of 3 capsules/ 5 ml twice daily).
raztopine za 33% (4 kapsule/ ~6, 5 ml dvakrat dnevno, namesto 3 kapsule/ 5 ml dvakrat dnevno).
Caution is warranted since this dosage adjustment might be
Previdnost je utemeljena, saj je lahko tako prilagajanje
insufficient in some patients.
odmerkov pri nekaterih bolnikih nezadostno.
The dosage of lopinavir/ ritonavir tablets should be increased to 500/ 125 mg
Pri jemanju z efavirenzem 600 mg enkrat na dan
twice daily when co-administered with efavirenz 600 mg once daily.
je treba odmerek lopinavir/ ritonavir tablet povečati na 500/ 125 mg dvakrat na dan.
80 Medicinal product by therapeutic
Zdravilne učinkovine po
co-administration with efavirenz
Pri uporabi efavirenza z majhnim
Raltegravir/ Efavirenz (400 mg single dose/ -)
raltegravir/ efavirenz (400 mg enkratni odmerek / -) NRTI- ji in NNRTI- ji
81 Medicinal product by therapeutic
Prilagoditev odmerka ni potrebna za nobeno od teh zdravil.
areas (dose)
Priporočilo glede sočasne
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
terapevtskih področjih
co-administration with efavirenz
učinkovin
NRTIs and NNRTIs NRTIs/ Efavirenz
uporabe z efavirenzem
Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil fumarate.
Srednja sprememba AUC, Cmax, Cmin z intervali zaupanja, če so na voljoa (mehanizem)
No dosage adjustment is necessary for either medicinal product.
zidovudinom in tenofovirdizoproksilfumaratom, niso opravili.
Rifabutin/ Efavirenz (300 mg once daily/ 600 mg once daily)
Zdravilne učinkovine po terapevtskih področjih
Rifabutin:
Učinki
AUC: ↓ 38% (↓ 28 to ↓ 47) Cmax: ↓ 32% (↓ 15 to ↓ 46) Cmin: ↓ 45% (↓ 31 to ↓ 56) Efavirenz:
na koncentracije učinkovin
AUC: ↔ Cmax: ↔ Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction)
(odmerek)
The daily dose of rifabutin should be increased by 50% when administered with efavirenz.
Srednja sprememba AUC, Cmax, Cmin z intervali zaupanja, če so na voljoa (mehanizem)
Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week in combination with efavirenz.
Zdravila za zdravljenje okužb z mikobakterijami rifabutin/ efavirenz
82 Medicinal product by therapeutic
Pri sočasni uporabi z efavirenzem
Effects on drug levels
AUC: ↓ 38% (↓ 28 do↓ 47)
Recommendation concerning
je treba dnevni odmerek rifabutina
areas (dose)
na dan)
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
AUC: ↔ Cmax: ↔ Cmin: ↓ 12% (↓ 24 do ↑ 1) (indukcija CYP3A4)
co-administration with efavirenz
Pri režimih, kjer se rifabutin daje 2 - ali 3- krat na teden v kombinaciji z efavirenzem, je treba pretehtati možnost podvojitve odmerka rifabutina.
Rifampicin/ Efavirenz (600 mg once daily/ 600 mg once daily) Antifungals
rifampicin/ efavirenz (600 mg enkrat na dan/ 600 mg enkrat na dan)
83 Medicinal product by therapeutic
Zdravilne učinkovine po
co-administration with efavirenz
Pri sočasni uporabi efavirenza in
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i. e., to 300 mg once daily.
Ko je zdravljenje z vorikonazolom
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored.
uvesti začetni odmerek efavirenza.
Ketoconazole and other imidazole antifungals ACID REDUCING AGENTS
ketokonazol in drugi imidazolski antimikotiki ZDRAVILA ZA KISLINSKO POGOJENE BOLEZNI
Lorazepam/ Efavirenz (2 mg single dose/ 600 mg once daily)
lorazepam/ efavirenz (enkratni odmerek 2 mg/ 600 mg enkrat na dan)
84 Medicinal product by therapeutic
Zdravilne učinkovine po
ANTICONVULSANTS Carbamazepine/ Efavirenz (400 mg once daily/ 600 mg once daily)
karbamazepin/ efavirenz (400 mg enkrat na dan/ 600 mg enkrat na dan)
Vigabatrin/ Efavirenz Gabapentin/ Efavirenz ANTIDEPRESSANTS
vigabatrin/ efavirenz gabapentin/ efavirenz
Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/ Efavirenz (50 mg once daily/ 600 mg once daily)
88
AUC: ↔ Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
Zdravilne učinkovine po terapevtskih področjih
Sertraline dose increases should be guided by clinical response.
Učinki
85 Medicinal product by therapeutic
na koncentracije učinkovin
Effects on drug levels
Priporočilo glede sočasne uporabe z efavirenzem
co-administration with efavirenz
Odmerek sertralina je treba
Paroxetine/ Efavirenz (20 mg once daily/ 600 mg once daily)
(50 mg enkrat na dan/ 600 mg enkrat na AUC: ↓ 39% (↓ 27 do ↓ 50) dan) Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58) efavirenz:
No clinically significant pharmacokinetic interaction
Prilagoditev odmerka efavirenza ni potrebna.
No dosage adjustment is necessary for either medicinal product.
paroksetin/ efavirenz Ni klinično pomembnih (20 mg enkrat na dan/ 600 mg enkrat na farmakokinetičnih interakcij. dan)
Fluoxetine/ Efavirenz ANTIHISTAMINES
Prilagoditev odmerka ni potrebna za nobeno od teh zdravil.
Interaction not studied.
fluoksetin/ efavirenz Interakcij niso preučevali.
Since fluoxetine shares a similar metabolic profile with paroxetine, i. e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
ANTIHISTAMINIKI
Cetirizine:
cetirizin/ efavirenz cetirizin:
No dosage adjustment is necessary for either medicinal product.
ZDRAVILA ZA BOLEZNI SRCA IN OŽILJA Zaviralci kalcijevih kanalčkov
Diltiazem/ Efavirenz (240 mg once daily/ 600 mg once daily)
Prilagoditev odmerka ni potrebna za nobeno od teh zdravil.
Diltiazem:
diltiazem/ efavirenz diltiazem:
AUC: ↓ 69% (↓ 55 to ↓ 79) Cmax: ↓ 60% (↓ 50 to ↓ 68) Cmin: ↓ 63% (↓ 44 to ↓ 75) Desacetyl diltiazem:
(240 mg enkrat na dan/ 600 mg enkrat AUC: ↓ 69% (↓ 55 do ↓ 79) na dan) Cmax: ↓ 60% (↓ 50 do ↓ 68) Cmin: ↓ 63% (↓ 44 do ↓ 75) desacetildiltiazem:
Verapamil, Felodipine, Nifedipine and Nicardipine
verapamil, felodipin, nifedipin in Interakcij niso preučevali.
When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Pri nikardipin sočasni uporabi efavirenza in zaviralca kalcijevih kanalčkov, ki je substrat za encim
Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Odmerke zaviralcev kalcijevih kanalčkov je treba prilagoditi glede na klinični odziv (glejte Povzetek glavnih značilnosti zdravila za
86 Medicinal product by therapeutic
89
Effects on drug levels
Zdravilne učinkovine po Učinki na koncentracije
Recommendation concerning
Priporočilo glede sočasne
areas (dose)
uporabe z efavirenzem
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
CYP3A4, obstaja možnost za zmanjšanje plazemskih koncentracij zaviralca kalcijevih kanalčkov.
co-administration with efavirenz
zaviralec kalcijevih kanalčkov).
LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/ Efavirenz (10 mg once daily/ 600 mg once daily)
ZDRAVILA ZA ZMANJŠANJE RAVNI LIPIDOV Zaviralci HMG Co- A- reduktaze atorvastatin/ efavirenz
Rosuvastatin/ Efavirenz HORMONAL CONTRACEPTIVES
Učinki na koncentracije
Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Ker se rosuvastatin v veliki meri izloči nespremenjen z blatom, ne pričakujemo interakcij z efavirenzom.
No dosage adjustment is necessary for either medicinal product.
Prilagoditev odmerka ni potrebna za nobeno od zdravil.
Ethinyloestradiol/ Efavirenz (50 µg single dose/ 400 mg once daily)
etinilestradiol/ efavirenz (enkratni odmerek 50 µg/ 400 mg enkrat na dan)
areas (dose)
IMUNOSUPRESIVI
IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (e. g., cyclosporine, tacrolimus, sirolimus)/ Efavirenz OPIOIDS
Imunosupresivi, ki se presnavljajo s CYP3A4 (npr. ciklosporin, takrolimus, sirolimus) / efavirenz OPIOIDI
4.6 Pregnancy and lactation
91 4. 6 Nosečnost in dojenje
Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Ženske v rodni dobi: ženske, ki se zdravijo z efavirenzem, se morajo izogibati nosečnosti.
88 Lactation: studies in rats have demonstrated that efavirenz is excreted in milk reaching concentrations much higher than those in maternal plasma.
Dojenje: raziskave pri podganah so pokazale, da se efavirenz izloča v materino mleko, pri čemer dosega veliko višje koncentracije kakor v materini plazmi.
The most notableadverse reactions associated with efavirenz are rash and nervous system symptoms (see section 4.4).
Najpomembnejši neželeni učinki, povezani z efavirenzem, so izpuščaj in simptomi živčnega sistema (glejte poglavje 4. 4).
Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila iz razreda NNRTI- jev, so izkušnje z efavirenzem omejene.
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Spodaj so našteti neželeni učinki zmerne ali hujše resnosti, katerih vzročna povezava z zdravljenjem je bila (s strani raziskovalca) ocenjena najmanj kot mogoča in so jih poročali iz kliničnih raziskav
Nervous system disorders common
Bolezni živčevja pogosti
90 Ear and labyrinth disorders uncommon
Ušesne bolezni, vključno z motnjami labirinta
Gastrointestinal disorders
Bolezni prebavil pogosti
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja zelo pogosti
very common
izpuščaj
Pruritus
srbenje
General disorders and administration site conditions common
Splošne težave in spremembe na mestu aplikacije
Fatigue
pogosti
Immune system disorders
utrujenost
uncommon
Bolezni imunskega sistema občasni
Gynaecomastia
Psihiatrične motnje
Lipodystrophy and metabolic abnormalities:
Lipodistrofija in metabolne motnje:
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Prerazporeditev maščevja (lipodistrofija) pri bolnikih s HIV, vključno z izgubo perifernega in obraznega podkožnega maščevja, povečano intraabdominalno in visceralno maščevje, hipertrofijo prsi in akumulacijo dorzocervikalnega maščevja (bikovska grba) so povezali s kombiniranim protiretrovirusnim zdravljenjem.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
94 Kombinirano protiretrovirusno zdravljenje so povezali s pojavom metabolnih motenj, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in povišana vrednost laktata v krvi (glejte poglavje 4. 4).
Liver enzymes: elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients
Povišanje aspartat aminotransferaze (AST) in alanin aminotransferaze (ALT) na več kot petkratno zgornjo mejo normalnih vrednosti (ZMN) so opazili pri 3% od 1. 008 bolnikov, zdravljenih s 600 mg efavirenza (5– 8% po dolgotrajnem zdravljenju v raziskavi 006).
Elevations of gamma-glutamyltransferase (GGT) to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5 - 2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment).
Povišanje gama glutamiltransferaze (GGT) na več kot petkratno ZMN so opazili pri 4% bolnikov, zdravljenih s 600 mg efavirenza, in pri 1, 5– 2% bolnikov, zdravljenih s kontrolnim režimom (po dolgotrajnem zdravljenju pri 7% bolnikov, zdravljenih z efavirenzem, in 3% bolnikov, zdravljenih s kontrolnim režimom).
Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
Diarrhoea occurred in six of nineteen (32%) children, aged 3 – 8 years, who took efavirenz oral solution in combination with nelfinavir (20 – 30 mg/ kg given three times a day) and one or more NRTIs.
Driska se je pojavila pri šestih od devetnajstih (32%) otrok, starih od 3 do 8 let, ki so jemali efavirenz peroralno raztopino v kombinaciji z nelfinavirjem (20 – 30 mg/ kg trikrat dnevno) in enim ali večimi NRTI- ji.
92 4.9 Overdose
4. 9 Preveliko odmerjanje
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Profili navzkrižne rezistence na efavirenz, nevirapin in delavirdin v celičnih kulturah so pokazali, da substitucija K103N povzroči izgubo občutljivosti na vse tri NNRTI- je.
93 The potential for cross resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Možnost navzkrižne rezistence med efavirenzem in zaviralci proteaze je majhna, ker pri tem sodelujejo različni tarčni encimi.
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/ mm3, or in PI or NNRTI-experienced patients.
Efavirenza niso preučevali v kontroliranih raziskavah bolnikov z napredovano boleznijo HIV, to je pri bolnikih s CD4 < 50 celic/ mm3, ali bolnikih, ki so se zdravili z zaviralcem proteaze ali NNRTI- ji.
Table 3:
97 Preglednica 3:
Responder rates (NC = Fa) Plasma HIV-RNA
bolnikov, ki so se odzvali na zdravljenje (NK = NAa) plazemska HIV- RNA
<
< 400
400 copies/ ml (95% C. I. b)
kopij/ ml < 50 kopij/ ml
< 50 copies/ ml (95% C. I. b)
% C. I. b)
48 weeks
tednov 48 tednov
ZDV + 3TC EFV + IDV IDV +
EFV + IDV IDV + ZDV + 3TC a
(38
(60 (47 (38
%, 52%)
%, 73%) 54%%, 61%) 45%%, 52%)
(34
(55 (41 (34
%, 47%)
%, 69%) 48%%, 55%) 40%%, 47%)
(12.3)
(11, 8) 177 (11, 3) 153 (12, 3)
NC = F, noncompleter = failure. b C. I., confidence interval. c S. E. M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
NK = NA, ni končal = napaka analize b C. I., interval zaupanja c S. E. M., standardna napaka povprečja d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
94 Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Rezultate učinkovitosti v raziskavah ACTG 364 in 020 prikazuje preglednica 4.
baseline-CD4 cell count
celic/ mm3 (S. E. M. d)
(95
%%
In uninfected adult volunteers, the Cmax and AUC of a 240 mg dose of STOCRIN oral solution were 78% and 97%, respectively, of the values measured when STOCRIN was given as a 200 mg hard capsule.
Pri neokuženih odraslih prostovoljcih sta bila Cmax in AUC 240 mg odmerka STOCRIN peroralne raztopine zmanjšana na 78% in 97% izmerjenih vrednosti, ko je bil STOCRIN uporabljen v obliki 200 mg trde kapsule.
95 Effect of food: the AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30% and 43% respectively, when given with a high-fat meal, relative to fasted conditions.
Vpliv hrane: pri neokuženih odraslih prostovoljcih sta bila AUC in Cmax 240 mg odmerka peroralne raztopine ob obroku z veliko maščobami povečana za 30% oziroma 43% v primerjavi z vrednostima na tešče.
In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Pri neokuženih prostovoljcih so 10- dnevni večkratni odmerki 200 - 400 mg dnevno povzročili manjšo akumulacijo zdravila od pričakovane (22 – 42% manjšo) in krajši terminalni razpolovni čas čas v primerjavi z enkratnim odmerkom (glejte spodaj).
In the single patient studied with severe hepatic impairment (Child Pugh Grade C), half life was doubled indicating a potential for a much greater degree of accumulation.
99 Pri edinem bolniku s hudo jetrno okvaro (stopnja C po Child Pugh- u) je bil razpolovni čas dvakrat daljši, kar kaže na možnost veliko večje akumulacije.
Paediatric pharmacokinetics: the equivalent of a 600 mg dose of efavirenz was given as hard capsules (dose adjusted from calculated body size based on weight) to 49 paediatric patients.
Pediatrična farmakokinetika: pri 49 pediatričnih bolnikih, ki so dobivali odmerek, ekvivalenten 600 mg odmerku efavirenza (odmerek je bil prilagojen velikosti telesa, izračunan glede na telesno težo), je bila Cmax v stanju ravnotežja 14, 1 μM, Cmin v stanju ravnotežja 5, 6 μM in AUC 216 μM· h.
The pharmacokinetics of efavirenz in paediatric patients were similar to adults.
17 pediatričnih bolnikov je dobivalo raziskovalno študijsko raztopino, podobno raztopini na tržišču.
Steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
Odmerek, ki so ga dobivali je bil prilagojen na telesno velikost tako, da je bil primerljiv s 600 mg odmerkom v kapsuli za odrasle.
In 17 paediatric patients receiving an investigational oral solution similar to the commercial formulation adjusted on the basis of body size to be equivalent to an adult 600 mg capsule dose, the steady-state Cmax was 11.8 μ M, steady state Cmin was 5.2 μ M, and AUC was 188 μ M·h.
Cmax je bila v stanju ravnotežja 11, 8 μM, Cmin v stanju ravnotežja 5, 2 μM in AUC 188 μM· h.
In the subset of 6 children aged 3 – 5 who were compliant with their drug regimen, the mean AUC was 147 μ M·h, which was 23% lower than expected.
V podskupini 6 otrok starih 3 do 5 let, ki so zdravilo dobivali v skladu z navodili, je bil povprečni AUC 147 μM· h, kar je bilo 23% manj od pričakovanega.
Anencephaly and unilateral anophthalmia
Malformacije so opazili pri 3 od 20 opičjih zarodkov/ novorojencev vrste Cynomolgus, ki so bili zdravljeni z efavirenzem v odmerkih, s katerimi so dosegli plazemske koncentracije efavirenza, ki so podobne tistim pri človeku.
96 with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Pri enem zarodku so opazili anencefalijo in unilateralno anoftalmijo s sekundarno povečanim jezikom, pri drugem mikrooftalmijo in pri tretjem razcepljeno nebo.
Medium chain triglycerides Benzoic acid (E210) Strawberry/ mint flavour
srednjeverižni nasičeni trigliceridi benzojska kislina (E210) aroma jagode/ mete
6.3 Shelf life
100 6. 3 Rok uporabnosti
HDPE bottles with a child-resistant polypropylene closure containing 180 ml of oral solution.
Steklenička iz HDPE s polipropilenskim za otroke varnim zamaškom, ki vsebujejo po 180 ml peroralne raztopine.
An oral syringe with a push-in bottle-neck adapter is included in the carton.
V zloženki je brizga za peroralno dajanje z nastavkom.
EU/ 1/ 99/ 111/ 005 - bottle
EU/ 1/ 99/ 111/ 005 - plastenka
98 1.
101 102 1.
Excipient: each film-coated tablet contains 249.6 mg of lactose monohydrate.
Pomožne snovi: ena filmsko obložena tableta vsebuje 294, 6 mg laktoze monohidrata.
Dark yellow, capsule-shaped, debossed with “ 225 ” on one side.
Temno rumene barve, v obliki kapsule, z oznako » 225 « na eni strani.
Adults: the recommended dosage of STOCRIN in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
V kombinaciji z zaviralci nukleozidne reverzne transkriptaze (NRTI- ji), z ali brez ZP, je priporočeni odmerek zdravila STOCRIN 600 mg peroralno, enkrat dnevno (glejte poglavje 4. 5).
STOCRIN is not
STOCRIN trde kapsule smemo dati le otrokom, ki so trde kapsule zmožni pogoltniti.
99 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
103 Zdravila STOCRIN za otroke, stare manj kot 3 leta ali lažje od 13 kg, zaradi pomanjkanja podatkov o varnosti in učinkovitosti za to starostno skupino ne priporočamo (glejte poglavji 5. 1. in 5. 2.).
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
* Na voljo so STOCRIN 50 mg, 200 mg in 600 mg filmsko obložene tablete.
100 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
The choice of new antiretroviral agent(s) to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance (see section 5.1).
Pri izbiri novega protiretrovirusnega zdravila (ali več takih 104 zdravil) za uporabo v kombinaciji z efavirenzem je treba upoštevati možnost pojava navzkrižne virusne rezistence (glejte poglavje 5. 1).
101 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Pri bolnikih, ki se zdravijo z efavirenzem, so opazili krče, običajno pri tistih z napadi krčev v anamnezi.