natgillin/translations-raw huggingface dataset:
EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
EFV + IDV + NRTI-ji IDV + NRTI-ji a NK = NA, ni končal = napaka analize b EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, zaviralec nukleozidne reverzne transkriptaze; NFV, nelfinavir.
Efavirenz Teva may make hormonal contraceptives less likely to work.
Efavirenz Teva lahko zmanjša delovanje hormonskih kontraceptivov.
AUC: ↔*/** (↓ 10 to ↑ 26) Cmax: ↔*/** (↓ 5 to ↑ 26) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49)
AUC: ↔*/** (↓ 10 do ↑ 26) Cmax: ↔*/** (↓ 5 do ↑ 26) Cmin : ↑ 12 %*/** (↓ 16 do ↑ 49)
It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
ki zmanjšuje količino virusa v krvi in se tako bori proti okužbi z virusom humane imunske pomanjkljivosti (HIV-1).
Delusion ‡, neurosis ‡, completed suicide‡,* Nervous system disorders Common Cerebellar co-ordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)* Uncommon Agitation, amnesia, ataxia, co-ordination abnormal, convulsions, thinking abnormal*, tremor†
Bolezni živčevja pogosti motnje cerebelarne koordinacije in ravnotežja†, motnje koncentracije (3,6 %), omotica (8,5 %), glavobol (5,7 %), zaspanost (2,0 %)*
Efavirenz Teva may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Med zdravilom Efavirenz Teva in drugimi zdravili, vključno s pripravki rastlinskega izvora, kot so izvlečki ginka (Ginkgo biloba), lahko pride do medsebojnega vpliva.
Amylase: In the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Amilaze: v kliničnem preizkušanju so v podskupini 1.008 bolnikov asimptomatska zvišanja vrednosti serumskih amilaz, večja kot 1,5-kratna zgornja meja normalne vrednosti, opazili pri 10 % bolnikov,
(CYP3A4 and CYP2B6 induction)
(indukcija CYP3A4 in CYP2B6)
<50 copies/ml (95% C.I.b)
< 50 kopij/ml (95-odstotni IZb)
Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Efavirenz Teva.
Zdravnik vam bo morda naročil, da pred začetkom zdravljenja z zdravilom Efavirenz Teva, opravite test nosečnosti, da se prepriča, da niste noseči.
No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h.
Geometrična srednja vrednost Cmin za indinavir (0,33 mg/l) pri dajanju z ritonavirjem in efavirenzem je bila večja kot srednja vrednost Cmin v preteklosti (0,15 mg/l) za indinavir samo v odmerku 800 mg na vsakih 8 ur.
The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Povišana koncentracija efavirenza, ki so jo opazili po zaužitju efavirenza s hrano, lahko vodi do povečane pogostosti neželenih učinkov (glejte poglavji 4.4 in 5.2).
Peak efavirenz plasma concentrations of 1.6-9.1 microM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Maksimalne plazemske koncentracije efavirenza, 1,6 - 9,1 µM, so bile pri neokuženih prostovoljcih dosežene 5 ur po dajanju enkratnih peroralnih odmerkov 100 mg do 1.600 mg. Od odmerka odvisna zvišanja Cmax in AUC so opazili pri odmerkih do 1.600 mg.
Other medicines and Efavirenz Teva You must not take Efavirenz Teva with certain medicines.
Zdravila Efavirenz Teva ne smete jemati skupaj z določenimi zdravili.
Liver enzymes in hepatitis B or C co-infected patients In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive).
Po dolgoročnih podatkih iz študije 006 je bilo ob presejanju seropozitivnih na hepatitis B (pozitivnih na površinski antigen) in/ali C (pozitivnih na protitelo proti hepatitisu C) 137 bolnikov na režimu, ki je vseboval efavirenz (mediana vrednost časa trajanja zdravljenja 68 tednov), in 84 bolnikov na kontrolnem režimu (mediana vrednost časa trajanja 56 tednov).
(PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
(PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Hrvaška Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
- Keep this leaflet.
(glejte spodaj).
Efavirenz Teva may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of efavirenz in your blood.
Zdravilo Efavirenz Teva lahko zmanjša količino vorikonazola v krvi, vorikonazol pa lahko poveča količino efavirenza v krvi.
Tests may show: - increased liver enzymes in the blood - increased triglycerides (fatty acids) in the blood
Testi lahko pokažejo: - povišane vrednosti jetrnih encimov v krvi
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
pojavijo tudi avtoimunske bolezni (stanja, do katerih pride, ko imunski sistem napade zdravo telesno tkivo).
Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
327 bolnikov, zdravljenih z NRTI, ne pa z ZP ali NNRTI.
Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
buprenorfinu se pri bolnikih niso pokazali odtegnitveni simptomi.
In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
(indukcija CYP3A4) V študiji pri uživalcih intravenskih drog, okuženih z virusom HIV, je sočasna uporaba efavirenza in metadona povzročila zmanjšanje ravni metadona v plazmi in znake odtegnitve od opiatov.
Approximately 14-34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Približno 14 - 34 % radiooznačenega odmerka efavirenza se je izločilo z urinom.
AUC: ↔* (↓ 9 to ↑ 10) Cmax: ↑ 17%* (↑ 8 to ↑ 27) Cmin: ↓ 42%* (↓ 31 to ↓ 51)
AUC: ↔* (↓ 9 do ↑ 10) Cmax: ↑ 17 %* (↑ 8 do ↑ 27) Cmin : ↓ 42 %* (↓ 31 do ↓ 51)
AUC: ↔ Cmax: ↑ 11% (↑ 3 to ↑19)
AUC: ↔ Cmax: ↑ 11 % (↑ 3 do ↑ 19)
- Methadone (a medicine used to treat opiate addiction): your doctor may recommend an alternative treatment.
- Metadon (zdravilo za zdravljenje odvisnosti od opiatov): zdravnik vam bo morda svetoval drugo zdravljenje.
Breast-feeding should be discontinued during treatment with efavirenz.
Med zdravljenjem z efavirenzem je treba dojenje prekiniti.
concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz.
Na začetku ali ob prenehanju zdravljenja z efavirenzem priporočamo skrbno spremljanje koncentracij imunosupresiva vsaj 2 tedna (dokler niso dosežene stabilne koncentracije).
Time to peak plasma concentrations (3-5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 67 days.
Čas za doseganje maksimalne plazemske koncentracije (3-5 ur) se pri večkratnem odmerjanju ni spremenil.
How to take Efavirenz Teva
Kako jemati zdravilo Efavirenz Teva
Efavirenz Teva 600 mg film-coated tablets
Efavirenz Teva 600 mg filmsko obložene tablete
Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes) such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Efavirenz je kontraindiciran pri sočasni uporabi zdravil (povzročijo lahko podaljšanje intervala QTc in torsade de pointes) kot so: antiaritmiki razreda IA in III, nevroleptiki in antidepresivi, določeni antibiotiki, vključno z nekaterimi učinkovinami iz naslednjih razredov: makrolidi, fluorokinoloni,
General disorders and administration site conditions Common Fatigue *,†, ‡ See section c. Description of selected adverse reactions for more details.
*, †, ‡ Za več podrobnosti glejte poglavje c. Opis izbranih neželenih učinkov.
AUC: ↓ 31% (↓ 8 to ↓47) Cmin: ↓ 40%
AUC: ↓ 31 % (↓ 8 do ↓ 47) Cmin: ↓ 40 %
- Ginkgo biloba extracts (a herbal preparation)
- Izvlečke ginka (pripravek rastlinskega izvora).
Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Efavirenza se ne sme jemati hkrati s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotaminom, dihidroergotaminom, ergonovinom in metilergonovinom), ker zaviranje njihovega metabolizma lahko povzroči resne,
There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when co-administered with efavirenz.
Pri sočasni uporabi z efavirenzem obstaja možnost zmanjšanja ali povečanja plazemskih koncentracij fenitoina, fenobarbitala in drugih antikonvulzivov, ki so substrati za izoencime CYP450.
The recommended dose of efavirenz 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 nukleozidnimi zaviralci reverzne transkriptaze (NRTI), z ali brez ZP, je priporočeni odmerek zdravila efavirenz 600 mg peroralno, enkrat na dan (glejte poglavje 4.5).
What Efavirenz Teva looks like and contents of the pack
Izgled zdravila Efavirenz Teva in vsebina pakiranja
Thirty-seven patients 3 months to 6 years of age (median 0.7 years) were treated with efavirenz.
Z efavirenzem se je zdravilo sedemintrideset bolnikov, starih od 3 mesecev do 6 let (mediana 0,7 leta).
Artemether/lumefantrine/efaviren z (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Antimalariki artemeter/lumefantrin/ efavirenz (20/120 mg tablete, 6 odmerkov po 4 tablete v 3 dneh /600 mg enkrat na dan)
The median time on study therapy was 181 weeks; 16% of patients discontinued before Week 48.
181 tednov; 16 % bolnikov je zdravljenje prekinilo pred 48. tednom.
Cellulose, microcrystalline Hydroxypropylcellulose Sodium laurilsulfate Sodium starch glycolate (Type A) Poloxamer 407
Jedro mikrokristalna celuloza hidroksipropilceluloza natrijev lavrilsulfat natrijev karboksimetilškrob (vrsta A) poloksamer 407 magnezijev stearat
Depomedroxyprogesterone acetate (DMPA)/efavirenz (150 mg IM single dose DMPA)
injekcija: depomedroksiprogesteronacetat (DMPA)/efavirenz (150 mg i.m.
Morning Cmin: ↑ 42% (↑ 9 to ↑ 86)
Cmin zjutraj: ↑ 42 % (↑ 9 do ↑ 86)b
If the co-administration of atazanavir with an NNRTI is required, an increase in 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.
Če je v kombinaciji z efavirenzem potrebna sočasna uporaba atazanavirja in NNRTI, lahko po potrebi in ob skrbnem kliničnem spremljanju povečate odmerek atazanavirja na 400 mg in odmerek ritonavirja na 200 mg.
The median time on study therapy was 132 weeks; 27% of patients discontinued before Week 48.
132 tednov; 27 % bolnikov je zdravljenje prekinilo pred 48. tednom.
AUC: ↑ 34% (↑ 18 to ↑ 53) Cmax: ↑ 49% (↑ 32 to ↑ 69)
AUC: ↑ 34 % (↑ 18 do ↑ 53) Cmax: ↑ 49 % (↑ 32 do ↑ 69)
Efavirenz Teva contains sodium
Zdravilo Efavirenz Teva vsebuje natrij
Pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole)
pimozid, imipramin, amitriptilin ali klomipramin (za zdravljenje določenih duševnih stanj) elbasvir ali grazoprevir (za zdravljenje hepatitisa C) šentjanževko (Hypericum perforatum) (rastlinski pripravek, ki se uporablja pri depresiji in tesnobi)
If you are currently taking any of the following medicines (see also “Other medicines and Efavirenz Teva): Astemizole or terfenadine (used to treat allergy symptoms) Bepridil (used to treat heart disease) Cisapride (used to treat heartburn)
- če trenutno jemljete katero koli od naslednjih zdravil (glejte tudi "Druga zdravila in zdravilo Efavirenz Teva"): astemizol ali terfenadin (za zdravljenje alergijskih simptomov) bepridil (za zdravljenje bolezni srca) - cisaprid (za zdravljenje zgage) - ergot alkaloide (kot na primer ergotamin, dihidroergotamin, ergonovin in metilergonovin) (za zdravljenje migrene in klaster glavobolov)
imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone.
imidazoli in triazolski antimikotiki, določeni nesedativni antihistaminiki (terfenadin, astemizol),
Cmax: ↓ 17% (↓ 6 to ↓ 26) b Cmin: ↓ 50% (↓ 40 to ↓ 59)
Cmax : ↓ 17 % (↓ 6 do ↓ 26)b Cmin : ↓ 50 % (↓ 40 do ↓ 59)
Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b
Cmin zvečer: ↑ 24 % (↑ 3 do ↑ 50)
LIPID-LOWERING MEDICINAL PRODUCTS HMG CoA Reductase Inhibitors Atorvastatin/efavirenz (10 mg once daily/600 mg once daily)
ZDRAVILA ZA ZMANJŠANJE RAVNI LIPIDOV Zaviralci HMG Co-A-reduktaze atorvastatin/efavirenz (10 mg enkrat na dan/600 mg enkrat na dan)
Methadone/efavirenz (stable maintenance, 35-100 mg once daily/600 mg once daily)
OPIOIDI metadon/efavirenz (stabilno vzdrževanje, 35-100 mg enkrat na dan/600 mg enkrat na dan)
Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
Študija PACTG 1021 je bila odprta študija za oceno farmakokinetike, varnosti, prenašanja in protivirusnega delovanja efavirenza v kombinaciji z didanozinom in emtricitabinom pri pediatričnih bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili.
- The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core.
Jedro tablete: mikrokristalna celuloza, hidroksipropilceluloza, natrijev lavrilsulfat, natrijev karboksimetilškrob (vrsta A), poloksamer 407 in magnezijev stearat.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV+IDV, 196 patients with EFV+ZDV+3TC and 127 patients with IDV+ZDV+3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ml, HIV-RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
IDV, 196 bolnikov, zdravljenih z EFV + ZDV + 3TC, in 127 bolnikov, zdravljenih z IDV + ZDV + 3TC) kažejo na dolgotrajnost odziva glede na deleže bolnikov s HIV RNA < 400 kopij/ml, HIV
Carbamazepine may make Efavirenz Teva less likely to work.
Karbamazepin lahko zmanjša delovanje zdravila Efavirenz Teva.
Co-administration of higher doses of either efavirenz or carbamazepine has not been studied.
Sočasne uporabe večjih odmerkov obeh, efavirenza ali karbamazepina,
Dose adjustment of buprenorphine or efavirenz may not be necessary when co-administered.
Pri sočasni uporabi prilagoditev odmerka buprenorfina ali efavirenza lahko ni potrebna.
Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/efavirenz (50 mg once daily/600 mg once daily)
Selektivni zaviralci ponovnega privzema serotonina (SSRI) sertralin/efavirenz (50 mg enkrat na dan/600 mg enkrat na dan)
006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 2.
Rezultate učinkovitosti študije 006 pri podskupini 614 bolnikov, vključenih vsaj
EU/1/11/742/001 (30 x 1 - blister PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - blister alu/alu)
EU/1/11/742/001 (30 x 1 - pretisni omot PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - pretisni omot alu/alu)
Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug-metabolising enzymes and/or transport proteins by St. John's wort.
Sočasna uporaba šentjanževke lahko zmanjša koncentracije efavirenza v plazmi, ker šentjanževka inducira encime, ki presnavljajo zdravilo in/ali transportne proteine.
Study AI266922 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with didanosine and emtricitabine in antiretroviral-naive and -experienced paediatric patients.
Študija AI266922 je bila odprta študija za oceno farmakokinetike, varnosti, prenašanja in protivirusnega delovanja efavirenza v kombinaciji z didanozinom in emtricitabinom pri pediatričnih bolnikih, ki so že bili zdravljeni ali še niso bili zdravljeni s protiretrovirusnimi zdravili.
No clinically significant pharmacokinetic interaction
Ni klinično pomembnih farmakokinetičnih interakcij.
Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders common hypertriglyceridaemia* uncommon hypercholesterolaemia*
Presnovne in prehranske motnje pogosti hipertrigliceridemija*
AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90)
AUC: ↓ 83 % (↓ 79 do ↓ 87) Cmax: ↓ 80 % (↓ 77 do ↓ 83) Cmin: ↓ 86 % (↓ 80 do ↓ 90)
ANTICOAGULANTS Warfarin/efavirenz Acenocoumarol/efavirenz
ANTIKOAGULANTI varfarin/efavirenz acenokumarol/efavirenz
Uncommon (affects 1 to 10 users in 1,000)
Občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov)
AUC: ↑ 20% (↑ 8 to ↑ 34) Cmax: ↑ 21% (↑ 10 to ↑ 33)
AUC: ↑ 20 % (↑ 8 do ↑ 34) Cmax : ↑ 21 % (↑ 10 do ↑ 33)
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46)
AUC: ↑ 21 % (↑ 10 do ↑ 34) Cmax: ↑ 14 % (↑ 4 do ↑ 26) Cmin: ↑ 25 % (↑ 7 do ↑ 46)b
- Efavirenz Teva is for oral use.
- Učinkovina je efavirenz.
- Once you start taking Efavirenz Teva, look out for: signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
če imate motnjo v delovanju srca, kot je nenormalen električni signal, ki se imenuje podaljšanje intervala QT. - Ko začnete jemati zdravilo Efavirenz Teva, bodite pozorni na: znake omotice, oteženo spanje, zaspanost, težave s koncentracijo ali nenormalne sanje.
Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
in ne zavira pomembno RT HIV-2 ali celičnih polimeraz DNA (α, β, γ ali δ).
Efavirenz Teva 600 mg film-coated tablets Efavirenz
Efavirenz Teva 600 mg filmsko obložene tablete efavirenz
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
(AIDS) in z oportunistično okužbo v anamnezi se lahko kmalu po začetku anti-HIV
(CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
Sočasna uporaba efavirenza z atorvastatinom, pravastatinom ali simvastatinom ni vplivala na vrednosti AUC ali Cmax efavirenza.
Ethinyloestradiol + norgestimate / efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
HORMONSKI KONTRACEPTIVI peroralni: etinilestradiol+norgestimat/efavir enz (0,035 mg+0,25 mg enkrat na dan/600 mg enkrat na dan)
Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔
AUC zjutraj: ↑ 18 % (↑ 6 do ↑ 33) AUC zvečer: ↔ Cmax zjutraj: ↑ 24 %
Grapefruit juice should be avoided when taking Efavirenz Teva.
Med jemanjem zdravila Efavirenz Teva se je potrebno izogibati uživanju soka grenivke.
Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment.
in omejenih kliničnih izkušenj pri bolnikih s kronično boleznijo jeter je potrebna previdnost pri predpisovanju efavirenza bolnikom z blago okvaro jeter.
Efavirenz Teva may reduce the amount of itraconazole in your blood.
Zdravilo Efavirenz Teva lahko zmanjša količino itrakonazola v krvi.
There have been occasional postmarketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients.
V obdobju trženja zdravila so pri bolnikih, ki so prejemali etonogestrel in efavirenz, občasno poročali o nezadostnem delovanju kontraceptiva.
Telaprevir/efavirenz (1,125 mg q8h/600 mg once daily)
telaprevir/efavirenz (1,125 mg q8h/600 mg enkrat na dan)
AUC12: ↓ 45% (↓ 38 to ↓ 51) Cmax: ↓ 51% (↓ 37 to ↓ 62)
AUC12: ↓ 45% (↓ 38 do ↓51) Cmax: ↓ 51% (↓ 37 do ↓ 62)
- Film-coated tablet: yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other - Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30 x 1 / 90 x 1 film-coated tablets (in perforated unit dose blisters) or a multi-pack bundle or carton containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet).
- Pakiranja: 30, 90 filmsko obloženih tablet ali 30 x 1 / 90 x 1 filmsko obložena tableta (v perforiranem enoodmernem pretisnem omotu) ali kot omot ali škatla, ki vsebuje 90 filmsko obloženih tablet (3 škatle po 30 x 1 filmsko obloženo tableto).
The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Pri zaužitju zdravila efavirenz skupaj s hrano se lahko poveča izpostavitev efavirenzu in lahko pride do večje pogostnosti neželenih učinkov (glejte poglavje 4.4).
Efavirenz Teva can reduce or increase the amount of anticonvulsant in your blood.
Zdravilo Efavirenz Teva lahko zmanjša ali poveča količino zdravila proti krčem v krvi.
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.
Ker ima fluoksetin podoben presnovni profil kot paroksetin, tj. močno zavira
AUC: ↑ 17% (↑ 6 to ↑ 29) ** Cmax: ↔** *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (Competitive inhibition of oxidative metabolism)
*v primerjavi z 200 mg samim dvakrat na dan **v primerjavi s 600 mg samim enkrat na dan (kompetitivno zaviranje oksidativne presnove)
Common Abdominal pain, diarrhoea, nausea, vomiting Uncommon Pancreatitis
Bolezni prebavil pogosti bolečine v trebuhu, driska, navzea, bruhanje občasni pankreatitis
d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
a NK = NA, ni končal = napaka analize b IZ, interval zaupanja c S.N.P., standardna napaka povprečja d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
- Efavirenz Teva should never be used alone to treat HIV.
- Zdravilo Efavirenz Teva je treba jemati vsak dan. - Za zdravljenje HIV ne smete nikoli uporabljati zdravila Efavirenz Teva samega.
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, je izkušenj z efavirenzem malo.