natgillin/translations-raw huggingface dataset:
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Neustrezne vrednosti lipidov je potrebno ustrezno klinično obravnavati (glejte poglavje 4. 8).
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pri bolnikih z obstoječimi motnjami v delovanju jeter, vključno z aktivnim kroničnim hepatitisom, se med kombiniranim protiretrovirusnim zdravljenjem nepravilnosti v delovanju jeter pojavljajo bolj pogosto; bolnike je treba spremljati v skladu z utečeno prakso.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Če pride do poslabšanja bolezni jeter ali če vrednosti serumskih transaminaz vztrajajo na več kot petkratni zgornji meji normalnega območja, je treba pretehtati koristi nadaljevanja zdravljenja z efavirenzem z možnim tveganjem pomembne
Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Vpliv ledvične okvare na izločanje efavirenza bi moral biti torej minimalen (glejte poglavje 4. 2).
29 Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
V kliničnih raziskavah niso preučili zadostnega števila starejših bolnikov, da bi lahko ugotovili, ali se ti odzivajo drugače od mlajših bolnikov.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Efavirenz filmsko obložene tablete niso primerne za uporabo pri sicer redkih bolnikih s prirojenimi motnjami galaktozamije ali z malabsorbcijskim sindromom za glukozo/ galaktozo.
Individuals with these conditions may take efavirenz oral solution, which is free from lactose.
Posamezniki s temi stanji lahko uporabljajo peroralno raztopino efavirenz, ki ne vsebuje laktoze.
Table 2:
31 Preglednica 2:
30 Medicinal product by therapeutic
atazanavir/ ritonavir/ efavirenz
AUC: ↔ */ ** (↓ 10% to ↑ 26%) Cmax: ↔ */ ** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/ ** (↓ 16% to ↑ 49%) (CYP3A4 induction). * When compared to atazanavir 300 mg/ ritonavir 100 mg once daily in the evening without efavirenz.
↑ 26%) Cmax: ↔ * / ** (↓ 5% do ↑ 26%) Cmin: ↑ 12% * / ** (↓ 16% do ↑ 49%) (indukcija CYP3A4) * v primerjavi z atazanavirom 300 mg/ ritonavirom 100 mg enkrat na dan zvečer brez efavirenza.
31 Medicinal product by therapeutic
32
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
Pri jemanju z indinavirom ali indinavirom/ ritonavirom indinavir/ ritonavir/ efavirenz (800 mg dvakrat na dan/ 100 mg
32 Medicinal product by therapeutic
33
33 Medicinal product by therapeutic
34
35 Medicinal product by therapeutic
aluminijev hidroksidni- magnezijev hidroksidni- simetikonijev antacid/ efavirenz (enkratni odmerek 30 ml/ enkratni odmerek 400 mg) famotidin/ efavirenz (enkratni odmerek 40 mg/ enkratni odmerek 400 mg) ANKSIOLITIKI
AGENTS
37
36 Medicinal product by therapeutic
Zdravilne učinkovine po terapevtskih področjih
37 Medicinal product by therapeutic
verapamil, felodipin, nifedipin in Interakcij niso preučevali.
Effects on drug levels
39
Rosuvastatin/ Efavirenz
40
38
Priporočilo glede sočasne
Efavirenz should not be used during pregnancy unless there are no other appropriate treatment options.
4. 6 Nosečnost in dojenje 41 Efavirenza se med nosečnostjo ne sme uporabljati, razen če ni na voljo drugih ustreznih možnosti zdravljenja.
39 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.
40 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.
41 Nervous system disorders common
Bolezni živčevja pogosti
42 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
44 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 treated with 600 mg of efavirenz (5 - 8% after long-term treatment in study 006).
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).
43 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.
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
46 treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
Table 3:
47 Preglednica 3:
Responder rates (NC = Fa) Plasma HIV-RNA
Delež bolnikov, ki so se odzvali na zdravljenje (NK = NAa) plazemska HIV- RNA
(60 (47
(60 (47 (38
45
%, 73%) 54%%, 61%) 45%%, 52%)
< 50 copies/ ml (95% C. I. b)
(55 (41 (34
cells/ mm3 (S. E. M. c)
%, 69%) 48%%, 55%) 40%%, 47%)
Responder rates (NC = Fa)
Delež bolnikov, ki so se odzvali na zdravljenje (NK = NAa) plazemska HIV- RNA
Mean change from
Povprečna sprememba od začetne vrednosti CD4
baseline-CD4 cell count
3 (S. E. M. d)
46 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
49 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.
Capsule core Sodium laurilsulfate Lactose monohydrate Magnesium stearate Sodium starch glycolate
Jedro kapsule natrijev lavrilsulfat monohidrat laktoze magnezijev stearat natrijev karboksimetilškrob
Capsule shell Gelatine Sodium laurilsulfate Titanium dioxide (E171) Silicon dioxide (E551)
Ovojnica kapsule želatina natrijev lavrilsulfat rumeni železov oksid (E172) titanov dioksid (E171) silicijev dioksid
Printing ink Cochineal carminic acid (E120) Iindigo carmine (E132) Titanium dioxide (E171)
Črnila za potisk škrlatna karminska kislina (E120) indigo karmin (E132) titanov dioksid (E171)
48 6.3 Shelf life
6. 3 Rok uporabnosti
EU/ 1/ 99/ 111/ 002 - bottle
EU/ 99/ 111/ 002 - plastenka
Excipient: each hard capsule contains 114 mg of lactose monohydrate.
Pomožne snovi: ena trda kapsula vsebuje 114 mg laktoze monohidrata.
Dark yellow, printed with “ 3809”.
Trde kapsule so temno rumene in imajo napis » 3809 «.
50 STOCRIN is not 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).
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.).
51 Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
53 Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in tenofovirdizoproksilfumarat, ne priporočamo.
52 Effect of food: the administration of STOCRIN with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Pri zaužitju zdravila STOCRIN skupaj s hrano se lahko poveča izpostavitev efavirenzu (glejte poglavje 5. 2) in lahko pride do večje pogostosti neželenih učinkov (glejte poglavje 4. 8).
53 Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
V kliničnih raziskavah niso preučili zadostnega števila starejših bolnikov, da bi lahko ugotovili, ali se ti odzivajo drugače od mlajših bolnikov.
Table 2:
56 Preglednica 2:
54 Medicinal product by therapeutic
atazanavir/ ritonavir/ efavirenz
55 Medicinal product by therapeutic
57
Lopinavir concentrations: similar to lopinavir/ ritonavir 400/ 100 mg twice daily without efavirenz
Podobnekot pri lopinaviru/ ritonaviru 400/ 100 mg dvakrat na dan brez efavirenza
56 Medicinal product by therapeutic
58
57 Medicinal product by therapeutic
59
AUC: ↓ 77% Cmax: ↓ 61% Efavirenz:
61
AUC: ↑ 44% Cmax: ↑ 38%
terapevtskih področjih
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
Srednja sprememba AUC, Cmax, Cmin z intervali zaupanja, če so na voljoa (mehanizem)
Voriconazole/ Efavirenz (400 mg twice daily/ 300 mg once daily)
(200 mg dvakrat na dan/ 400 mg enkrat
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored.
vorikonazola je treba vzdrževalni
Fluconazole/ Efavirenz (200 mg once daily/ 400 mg once daily)
na dan)
No clinically significant pharmacokinetic interaction
AUC: ↑ 44% Cmax: ↑ 38% vorikonazol:
No dosage adjustment is necessary for either medicinal product.
Ko je zdravljenje z vorikonazolom
Ketoconazole and other imidazole antifungals
vorikonazol/ efavirenz
Interaction not studied
Cmax: ↑ 23% (↓ 1 do ↑ 53) *
No data are available to make a dose recommendation.
končano, je potrebno ponovno
59 Medicinal product by therapeutic
(400 mg dvakrat na dan/ 300 mg enkrat na dan)
Effects on drug levels
efavirenz:
Recommendation concerning
uvesti začetni odmerek efavirenza.
areas (dose)
flukonazol/ efavirenz (200 mg enkrat na dan/ 400 mg enkrat na dan)
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Ni klinično pomembnih farmakokinetičnih interakcij.
ACID REDUCING
Interakcij niso preučevali.
AGENTS
Ker na voljo ni podatkov, ne moremo podati priporočila glede odmerjanja.
Aluminium hydroxide-magnesium hydroxide-simethicone antacid/ Efavirenz (30 mL single dose/ 400 mg single dose) Famotidine/ Efavirenz (40 mg single dose/ 400 mg single dose) ANTIANXIETY AGENTS
aluminijev hidroksidni- magnezijev hidroksidni- simetikonijev antacid/ efavirenz (enkratni odmerek 30 ml/ enkratni odmerek 400 mg) famotidin/ efavirenz (enkratni odmerek 40 mg/ enkratni odmerek 400 mg) ANKSIOLITIKI
Neither aluminium/ magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Niti aluminijevi/ magnezijevi hidroksidni antacidi niti famotidin niso spremenili absorpcije efavirenza.
Lorazepam/ Efavirenz (2 mg single dose/ 600 mg once daily) ANTICONVULSANTS
lorazepam/ efavirenz (enkratni odmerek 2 mg/ 600 mg enkrat na dan)
AUC: ↑ 7% (↑ 1 to ↑ 14) Cmax: ↑ 16% (↑ 2 to ↑ 32) These changes are not considered clinically significant.
AUC: ↑ 7% (↑ 1 do ↑ 14) Cmax: ↑ 16% (↑ 2 do ↑ 32) Ti spremembi se ne smatrata za klinično pomembni.
60 Medicinal product by therapeutic
Zdravilne učinkovine po terapevtskih področjih
61 Medicinal product by therapeutic
verapamil, felodipin, nifedipin in Interakcij niso preučevali.
Effects on drug levels
64
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total HMG Co-A reductase inhibitors:
AUC: ↓ 58% (↓ 39 do ↓ 68) Cmax: ↓ 51% (↓ 32 do ↓ 58) skupni aktivni zaviralci HMG Co- A- reduktaze:
AUC: ↓ 60% (↓ 54 to ↓ 74) Cmax: ↓ 70% (↓ 58 to ↓ 85) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
AUC: ↓ 60% (↓ 52 do ↓ 68) Cmax: ↓ 62% (↓ 55 do ↓ 78) (indukcija CYP3A4) Sočasna uporaba efavirenza z atorvastatinom, pravastatinom ali simvastatinom ni vplivala na vrednosti AUC ali Cmax efavirenza.
Rosuvastatin/ Efavirenz
65
62
Priporočilo glede sočasne
4.6 Pregnancy and lactation
66 4. 6 Nosečnost in dojenje
63 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.
64 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.
In clinical studies 2.1% of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.
V kliničnih raziskavah je 2, 1% bolnikov, zdravljenih s 600 mg, efavirenza prenehalo z zdravljenjem zaradi simptomov živčnega sistema.
65 Nervous system disorders common
Bolezni živčevja pogosti
66 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
69 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).
67 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.
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
71 treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
Table 3:
72 Preglednica 3:
%, 73%) 54%%, 61%)
%, 73%) 54%%, 61%) 45%%, 52%)
(55 (41
(55 (41 (34
%, 69%) 48%%, 55%)
%, 69%) 48%%, 55%) 40%%, 47%)
Mean change from
Povprečna sprememba od začetnih vrednosti CD4
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
ACTG 382 je nekontrolirana raziskava, ki še poteka pri 57- ih pediatričnih bolnikih v starosti 3 do 16 let, ki so zdravljeni z NRTI- ji, in analizira farmakokinetiko, protivirusno aktivnost in varnost efavirenza v kombinaciji z nelfinavirom (20- 30 mg/ kg trikrat dnevno) in enim ali več NRTI- jem.
The starting dose of efavirenz was the equivalent of a 600 mg dose (adjusted from calculated body size based on weight).
Začetni odmerek efavirenza je bil ekvivalenten 600 mg (prilagojen glede na 73 izračunano velikost telesa na podlagi telesne teže).
70 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
74 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.
Capsule shell Gelatine Sodium laurilsulfate Yellow iron oxide (E172) Silicon dioxide (E551)
Ovojnica kapsule želatina natrijev lavrilsulfat rumeni železov oksid (E172) titanov dioksid (E171) silicijev dioksid
Printing ink Cochineal carminic acid (E120) Indigo carmine (E132) Titanium dioxide (E171)
Črnila za potisk škrlatna karminska kislina (E120) indigo karmin (E132) titanov dioksid (E171)
6.2 Incompatibilities
75 6. 2 Inkompatibilnosti
72 6.3 Shelf life
6. 3 Rok uporabnosti
For bottles:
Za plastenke:
3 years For blisters:
Za pretisne omote:
Packs of 42 x 1 hard capsules in aluminium perforated unit dose blisters.
Zloženke z 42 x 1 trdimi kapsulami v aluminijevih perforiranih pretisnih omotih za enkratne odmerke.
EU/ 1/ 99/ 111/ 003 - bottle EU/ 1/ 99/ 111/ 004 - blister
EU/ 1/ 99/ 111/ 003 - plastenka EU/ 1/ 99/ 111/ 004 - pretisni omot
28 May 2004.
28. maj 1999
STOCRIN 30 mg/ ml oral solution
STOCRIN 30 mg/ ml peroralna raztopina
Colourless to slightly yellow clear liquid.
Brezbarvna do svetlo rumena bistra tekočina.
STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the hard capsules or the film-coated tablets.
4. 1 Terapevtske indikacije
STOCRIN oral solution may be taken with or without food (see section 5.2).
STOCRIN peroralna raztopina se lahko jemlje s hrano ali brez nje (glejte poglavje 5. 2).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
Da bi bolniki bolje prenašali neželene učinke na živčni sistem, priporočamo v prvih dveh do štirih tednih zdravljenja in pri bolnikih, pri katerih se ti simptomi nadaljujejo, odmerjanje zvečer pred spanjem (glejte poglavje 4. 8).
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 24 ml orally, once daily.
V kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze (NRTI- ji), z ali brez ZP, je priporočeni odmerek efavirenza 24 ml peroralno enkrat dnevno (glejte poglavje 4. 5).
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN oral solution in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
V kombinaciji z ZP in/ ali NRTI- ji je priporočeni odmerek STOCRIN peroralne raztopine za bolnike stare od 3 do 17 let naveden v Preglednici 1.
STOCRIN hard capsules or film-coated tablets must only be administered to children who are able to reliably swallow capsules or tablets.
STOCRIN trde kapsule ali filmsko obložene tablete smemo dati le otrokom, ki so kapsule ali tablete zmožni pogoltniti.
74 STOCRIN is not 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).
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 oral solution (30 mg/ ml) Dose (ml)
STOCRIN peroralna raztopina (30 mg/ ml) Odmerek (ml) Otroci 3 - < 5 let Odrasli in otroci stari 5 let ali več
13 to < 15 15 to < 20 20 to < 25
13 do < 15 15 do < 20 20 do < 25 25 do < 32. 5 32. 5 do < 40 ≥ 40
12 13 15
12 9 13 10 15 12 17 15 - 17 - 24
STOCRIN oral solution is less bioavailable than the hard capsule on a mg per mg basis.
Biološka uporabnost 1 mg efavirenza v peroralni raztopini STOCRIN je manjša od 1 mg efavirenza v trdih kapsulah STOCRIN.
The dose recommendations in Table 1 have been adjusted to take into account the difference in bioavailability (see section 5.2).
Priporočeni odmerki v Preglednici 1 so prilagojeni glede na različno biološko uporabnost (glejte poglavje 5. 2).
Renalimpairment: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
Farmakokinetike efavirenza pri bolnikih z ledvično odpovedjo niso preučevali, vendar se manj kot 1% odmerka efavirenza izloči nespremenjenega v urinu, tako da naj bi bil učinek ledvične odpovedi na izločanje efavirenza minimalen (glejte poglavje 4. 4).
Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Efavirenza se ne sme uporabljati hkrati s terfenadinom, astemizolom, cisapridom, midazolamom ali triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin), ker bi kompeticija z efavirenzem za CYP3A4 lahko povzročila inhibicijo metabolizma in hude in/ ali življenjsko nevarne neželene učinke [na primer srčne aritmije, podaljšano sedacijo ali depresijo dihanja] (glejte poglavje 4. 5).
75 4.4 Special warnings and precautions for use
78 4. 4 Posebna opozorila in previdnostni ukrepi
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in tenofovirdizoproksilfumarat, ne priporočamo.
76 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.
In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
80 Pri bolnikih, ki se zdravijo z drugimi zdravili, ki so toksična za jetra, prav tako priporočamo spremljanje jetrnih encimov.
77 Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Vpliv ledvične okvare na izločanje efavirenza bi moral biti torej minimalen (glejte poglavje 4. 2).
Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
V kliničnih raziskavah niso preučili zadostnega števila starejših bolnikov, da bi lahko ugotovili, ali se ti odzivajo drugače od mlajših bolnikov.
Paediatric patients: efavirenz has not been evaluated in children below 3 years of age or who weigh less than 13 kg.
Pri otrocih mlajših od 3 let ali lažjih od 13 kg uporabe efavirenza niso preučili.
For this reason, efavirenz oral solution should not be given to children less than 3 years of age.
Zaradi tega uporabe peroralne raztopine efavirenza pri otrocih mlajših od 3 let ne priporočamo.
Table 2:
81 Preglednica 2:
If the co-administration of atazanavir with an NNRTI is required, an increase in
Če je v kombinaciji z efavirenzem potrebna sočasna uporaba atazanavira in NNRTI, lahko razmislite o povečanju odmerka atazanavira na 400 mg in
Medicinal product by therapeutic areas (dose)
atazanavir/ ritonavir/ efavirenz