natgillin/translations-raw huggingface dataset:
EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
IDV + NRTIs a NC = F, ispitanici koji ne završe = terapijski neuspjeh. b EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nukleozidni inhibitor reverzne transkriptaze; NFV, nelfinavir.
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).
Prema podacima dugoročnog ispitivanja iz studije 006, 137 bolesnika na protokolu koji je uključivao efavirenz (medijan trajanja terapije 68 tjedana) i 84 bolesnika na kontrolnom protokolu (medijan trajanja 56 tjedana) bilo je seropozitivno na skriningu na hepatitis B (pozitivan površinski antigen) i/ili hepatitis C (pozitivno protutijelo na hepatitis C).
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Efavirenz Teva.
liječnik će Vam možda morati provjeriti razinu antikonvulzivnog lijeka u krvi kako bi bio siguran da se nije promijenila zbog uzimanja Efavirenza Teva.
- Efavirenz Teva should never be used alone to treat HIV.
- Efavirenz Teva nikada ne smijete uzimati kao jedini lijek za liječenje HIV infekcije.
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).
Farmakokinetika efavirenza nije ispitivana u bolesnika s insuficijencijom bubrega, no s obzirom da se manje od 1% efavirenza izlučuje mokraćom u nepromijenjenom obliku, utjecaj oštećenja bubrega na eliminacija efavirenza trebao bi biti minimalan (vidjeti dio 4.4).
Efavirenz Teva may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of efavirenz in your blood.
Efavirenz Teva može smanjiti koncentraciju vorikonazola u krvi, a vorikonazol može povećati koncentraciju efavirenza u krvi.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Virusni izolati dobiveni iz mononuklearnih stanica periferne krvi bolesnika s dokazanim terapijskim neuspjehom u kliničkim ispitivanjima efavirenza (povrat virusnog opterećenja), ispitani su na osjetljivost na NNRTI-je.
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.
U ispitivanju intravenskih ovisnika zaraženih HIV virusom istodobna primjena efavirenza i metadona dovela je do sniženja koncentracije metadona u plazmi i znakova ustezanja od opijata.
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.
Vršne koncentracije efavirenza u plazmi od 1,6-9,1 μM postignute su u nezaraženih dobrovoljaca 5 sati nakon jednokratne primjene oralnih doza lijeka od 100 do 1600 mg.
Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Psihijatrijski poremećaji često neuobičajeni snovi, anksioznost, depresija, nesanica * manje često emocionalna labilnost, agresija, stanje konfuzije, euforično raspoloženje,
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section
U periodičkim se razmacima moraju napraviti laboratorijske pretrage zbog procjene bolesti jetre (vidjeti dio 4.2).
EFV + NRTIs NFV + NRTIs Study 020
EFV + NRTIs NFV + NRTIs Ispitivanje 020 24 tjedna
You should not breast-feed your baby if you are taking Efavirenz Teva.
Ne smijete dojiti ako uzimate Efavirenz Teva.
AUC: ↔ Cmax: ↑ 50% (↑ 20 to ↑ 80)
AUC: ↔ Cmax: ↑ 50% (↑ 20 do ↑ 80)
It is recommended to be taken on an empty stomach preferably at bedtime.
Preporučuje se uzimati ga na prazan želudac, po mogućnosti prije spavanja.
AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) *
AUC: ↓ 7% (↓ 23 do ↑ 13) * Cmax: ↑ 23% (↓ 1 do ↑ 53) *
Efavirenz Teva 600 mg film-coated tablets
Efavirenz Teva 600 mg filmom obložene tablete
AUC: ↓ 25% (↓ 16 to ↓32)
AUC: ↓ 25% (↓ 16 do ↓32)
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).
Efavirenz se ne smije primjenjivati istodobno s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ili alkaloidima ražene glavnice (kao što su ergotamin, dihidroergotamin, ergonovin i metilergonovin) jer inhibicija njihovog metabolizma može uzrokovati ozbiljne i po život opasne događaje (vidjeti dio 4.3).
How to take Efavirenz Teva
Kako uzimati Efavirenz Teva
Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Efavirenz je indiciran u kombiniranom antivirusnom liječenju odraslih, adolescenata i djece u dobi od
- Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin,
- Lijekove za liječenje konvulzija/napadaja (antikonvulzive): karbamazepin, fenitoin, fenobarbital.
(CYP3A4 and CYP2B6 induction)
(indukcija CYP3A4 i CYP2B6)
There have been occasional postmarketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients.
Nakon stavljanja lijeka u promet povremeno su prijavljeni izostanci kontraceptivnog učinka etonogestrela u bolesnika koji su uzimali efavirenz.
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.
Koncentracija efavirenza u plazmi može se smanjiti zbog istodobne primjene gospine trave, jer ista inducira enzime koji metaboliziraju lijek i/ili transportne proteine.
The mean baseline CD4 cell count was 341 cells/mm3 and the mean baseline HIV-RNA level was 60,250 copies/ml.
Prosječan početni broj CD4 stanica iznosio je 341 stanica/mm3, a prosječna početna vrijednost HIV-RNK bila je 60250 kopija/ml.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
- Methadone (a medicine used to treat opiate addiction): your doctor may recommend an alternative treatment.
- Metadon (lijek za liječenje ovisnosti o opijatima): liječnik će Vam možda preporučiti zamjensko liječenje.
Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme, psychiatric adverse reactions including severe depression, death by suicide, and psychosis-like behaviour, and seizures have been reported in patients treated with efavirenz.
U bolesnika liječenih efavirenzom prijavljene su teške kožne reakcije poput Stevens-Johnsonovog sindroma i erythema multiforme, psihijatrijske nuspojave, uključujući tešku depresiju, samoubojstvo i psihotično ponašanje te napadaji.
Proguanil:
Progvanil:
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)
Clinically significant interactions are not expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Klinički značajne interakcije se ne očekuju jer se vigabatrin i gabapentin izlučuju isključivo nepromijenjeni mokraćom i nije vjerojatno da će se natjecati za iste metaboličke enzime i puteve eliminacije s efavirenzom.
ZDV + 3TC a NC = F, noncompleter = failure.
ZDV + 3TC a NC = F, ispitanici koji ne završe = terapijski neuspjeh. b C.I., interval pouzdanosti.
Efavirenz Teva contains sodium
Efavirenz Teva sadrži natrij
These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Ove se nuspojave mogu početi pojavljivati prvog ili u prva dva dana liječenja i obično nestaju nakon prva 2 do 4 tjedna.
(500/125 mg twice daily/ 600 mg once daily)
(500/125 mg dvaput na dan/ 600 mg jedanput na dan)
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.
Dugoročni rezultati nakon 168 tjedana ispitivanja 006 (ispitivanje je završilo 160 bolesnika liječenih kombinacijom efavirenz + indinavir, 196 bolesnika liječenih kombinacijom efavirenz + zidovudin + lamivudin te 127 bolesnika liječenih kombinacijom indinavir + zidovudin + lamivudin) ukazuju na održanost odgovora na liječenje s obzirom na udio bolesnika s HIV-RNK <400 kopija/ml, HIV-RNK <50 kopija/ml, te s obzirom na srednju vrijednost promjene od početnog broja CD4 stanica.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C, prethodno liječeni kombiniranom antiretrovirusnom terapijom, izloženi su povećanom riziku od razvoja ozbiljnih i potencijalno smrtonosnih jetrenih nuspojava.
Lopinavir/ritonavir tablets/ efavirenz
Lopinavir/ritonavir tablete/ efavirenz
Co-administration of higher doses of either efavirenz or carbamazepine has not been studied.
Istovremena primjena većih doza bilo efavirenza ili karbamazepina nije ispitana.
Concomitant administration of atovaquone/proguanil with efavirenz should be avoided.
Istovremenu primjenu atovakvona/progvanila s efavirenzom treba izbjegavati.
Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Poremećaji jetre i žuči često povišena razina aspartat aminotransferaze (AST) *, povišena razina alanin aminotransferaze (ALT) *, povišena razina gama-glutamiltransferaze (GGT)* manje često akutni hepatitis rijetko zatajenje jetre
Hypromellose 6cP (HPMC 2910) Lactose monohydrate Titanium dioxide Macrogol/PEG 3350
Film ovojnica hipromeloza 6cP (HPMC 2910) laktoza hidrat titanijev dioksid makrogol/PEG 3350 triacetin 3 željezov oksid, žuti
Efavirenz Teva can reduce or increase the amount of anticonvulsant in your blood.
Efavirenz Teva može smanjiti ili povećati koncentraciju antikonvulziva u krvi.
Artemether/lumefantrine/efaviren z (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Artemeter/lumefantrin/efavirenz (20/120 mg tableta, 6 doza od po 4 tablete, tijekom 3 dana/600 mg jedanput na dan
Breast-feeding should be discontinued during treatment with efavirenz.
Tijekom terapije efavirenzom mora se prekinuti dojenje.
Lumefantrine:
lumefantrin:
problems with coordination or balance - stomach pain, diarrhoea, feeling sick (nausea), vomiting - itching - tiredness - feeling anxious, feeling depressed
pospanost, poteškoće s koordinacijom ili ravnotežom - bol u trbuhu, proljev, mučnina, povraćanje
No dose adjustment is necessary for any of these medicinal products.
Nije potrebno prilagođavati dozu niti jednog od ovih lijekova.
Liver enzymes: Elevations of AST and 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).
više od pet puta iznad gornje granice normale opažene su u 3% od 1008 bolesnika liječenih efavirenzom u dozi od 600 mg (5-8% nakon dugotrajnog liječenja u studiji 006).
AUC: ↔ Cmax: ↑ 11% (↑ 3 to ↑19)
AUC: ↔ Cmax: ↑ 11% (↑ 3 do ↑19)
Efavirenz can be re-initiated in patients interrupting therapy because of rash.
Moguće je ponovno započeti liječenje efavirenzom u bolesnika koji su ga zbog osipa prekinuli.
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)
concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz.
Kod uvođenja ili prekida liječenja efavirenzom, preporučuje se pažljivo pratiti koncentracije imunosupresiva tijekom najmanje 2 tjedna (dok se postignu stabilne koncentracije).
There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour and catatonia.
Nakon stavljanja lijeka u promet prijavljivani su slučajevi jake depresije, samoubojstava, deluzija, psihotičnog ponašanja i katatonije.
This combination should be used with caution.
Mora se nastaviti s primjenom odgovarajućih mjera opreza.
Co-administration of efavirenz with the fixed-combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil is not recommended, unless needed for dose adjustment (for example, with rifampicin).
emtricitabin i tenofovirdizoproksil, osim ako nije potrebno zbog prilagodbe doze (na primjer, s rifampicinom).
AUC: ↑ 34% (↑ 18 to ↑ 53) Cmax: ↑ 49% (↑ 32 to ↑ 69)
AUC: ↑ 34% (↑ 18 do ↑ 53) Cmax: ↑ 49% (↑ 32 do ↑ 69)
Atovaquone:
Atovakvon:
Elevations of 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).
Porast vrijednosti gamaglutamiltransferaze (GGT) do više od pet puta iznad gornje granice normale zabilježen je u 4% svih bolesnika koji su primali efavirenz u dozi od 600 mg i u 1,5-2% bolesnika liječenih kontrolnim protokolom (nakon dugotrajnog liječenja u 7% ispitanika koji su primali efavirenz i u 3% ispitanika u kontrolnom protokolu).
Ethinyloestradiol + norgestimate / efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
Etiniloestradiol + norgestimat / efavirenz (0,035 mg + 0,25 mg jedanput na dan/600 mg mg jedanput na dan)
Hydroxybupropion:
Hidroksibupropion:
Integrase strand transfer inhibitor Raltegravir/efavirenz (400 mg single dose/ -)
Inhibitori integraze Raltegravir/efavirenz (400 mg jednostruka doza/ -)
Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders common hypertriglyceridaemia* uncommon hypercholesterolaemia*
Poremećaji metabolizma i prehrane često hipertrigliceridemija* manje često hiperkolesterolemija*
< 400 copies/ml
< 400 kopija /ml
Common (affects 1 to 10 users in 100)
Često (javljaju se u 1 do 10 na 100 korisnika)
Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
364 uključeno je 196 bolesnika koji su već primali NRTI-je, ali ne i inhibitore proteaze ili NNRTI-je.
The net effect of coadministration is not clear
Neto učinak istodobne primjene nije razjašnjen.
Posaconazole/efavirenz (--/400 mg once daily)
Posakonazol/efavirenz (--/400 mg jedanput na dan)
AUC: ↓ 31% (↓ 8 to ↓47) Cmin: ↓ 40%
AUC: ↓ 31% (↓ 8 do ↓47) Cmin: ↓ 40%
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
U ispitivanju interakcija lijekova, istodobna primjena karbamazepina s efavirenzom snizila je koncentraciju karbamazepina u plazmi (vidjeti dio 4.5).
Hydroxyitraconazole:
Hidroksi-itrakonazol:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS EFAVIRENZ TEVA 600 mg FILM-COATED TABLET: BLISTER FOIL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP EFAVIRENZ TEVA 600 mg FILMOM OBLOŽENA
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Osip se obično javlja u prva dva tjedna od početka liječenja efavirenzom u obliku blagih do umjerenih makulopapuloznih kožnih erupcija.
(400/100 mg twice daily/ 600 mg once daily)
(400/100 mg dvaput na dan/ 600 mg jedanput na dan)
No dose adjustment is necessary for rifampicin, including 600 mg.
Nije potrebno prilagođavati dozu rifampicina, uključujući i dozu od
- Bupropion (a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
- Bupropion (lijek za liječenje depresije ili za pomoć pri prestanku pušenja): liječnik će Vam možda trebati promijeniti dozu bupropiona.
Rare (affects 1 to 10 users in 10,000)
Rijetko (javljaju se u 1 do 10 na 10 000 korisnika)
Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Koncentracije lopinavira: slično kao kod primjene lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan bez efavirenza
- Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.
- Jedna Efavirenz Teva filmom obložena tableta sadrži 600 mg djelatne tvari efavirenz.
These metabolites are essentially inactive against HIV-1.
Ovi metaboliti u pravilu nemaju učinak protiv
< 50 copies/ml
< 50 kopija /ml
Malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Kod cinomolgus ženki majmuna koje su primale efavirenz zabilježene su malformacije u 3 od 20 fetusa/novorođenih majmuna pri koncentracijama u plazmi sličnim onima u ljudi.
Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Pri prilagodbi doze blokatora kalcijevih kanala treba se voditi kliničkim odgovorom (vidjeti
Efavirenz Teva contains efavirenz and may cause dizziness, impaired concentration, and drowsiness.
Efavirenz Teva može prouzročiti omaglicu, smetnje koncentracije i pospanost.
If efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e. to 300 mg once daily.
Kod istodobne primjene s vorikonazolom, doza održavanja vorikonazola mora se povećati na 400 mg svakih 12 sati, a doza efavirenza smanjiti za 50%, odnosno na dozu od 300 mg jedanput na dan.
No clinically significant pharmacokinetic interaction
Nema klinički značajnih farmakokinetičkih interakcija
When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored (see section 4.5).
Nakon prestanka liječenja vorikonazolom, ponovo treba uvesti početnu dozu efavirenza (vidjeti dio
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Za lakše uklanjanje neapsorbiranog efavirenza, može se primijeniti aktivni ugljen.
Cmax: ↓ 17% (↓ 6 to ↓ 26) b Cmin: ↓ 50% (↓ 40 to ↓ 59)
Cmax: ↓ 17% (↓ 6 do ↓ 26) b Cmin: ↓ 50% (↓ 40 do ↓ 59)
Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Preporuke vezano za istodobnu primjenu s efavirenzom neizmijenjen putem stolice, pa se stoga ne očekuje interakcija s efavirenzom.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
konzumiranje alkohola, jaku imunosupresiju, povećani indeks tjelesne mase), prijavljeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom bolesti HIV-a i/ili u bolesnika na dugotrajnom liječenju kombiniranom antivirusnom terapijom.
The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost efavirenza u bolesnika koji su već imali značajne poremećaje jetrene funkcije nisu utvrđeni.
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).
Povišene koncentracije efavirenza nakon njegove primjene s hranom mogu povećati učestalost nuspojava (vidjeti dijelove 4.4 i 5.2).
Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/efavirenz (50 mg once daily/600 mg once daily)
Selektivni inhibitori ponovne pohrane serotonina (SSRI) Sertralin/efavirenz (50 mg jedanput na dan/600 mg
Reproductive system and breast disorders Uncommon Gynaecomastia
Poremećaji reproduktivnog sustava i dojki manje često ginekomastija
Efavirenz Teva 600 mg film-coated tablets Efavirenz
Efavirenz Teva 600 mg filmom obložene tablete efavirenz
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period) - whistling, ringing or other persistent noise in the ears - tremor (shaking) - flushing
ushita ili razdražljivosti), paranoja, suicidalne misli, katatonija (stanje u kojem je bolesnik neko vrijeme nepomičan i ne govori)
How to store Efavirenz Teva
Kako čuvati Efavirenz Teva
- nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts - blurred vision - a feeling of spinning or tilting (vertigo) - pain in the abdomen (stomach) caused by inflammation of the pancreas - allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
- osjećaj da se sve okreće ili tlo naginje (vrtoglavica) - bol u trbuhu (želucu) prouzročena upalom gušterače - alergijska reakcija (preosjetljivost) koja može prouzročiti teške kožne reakcije (multiformni eritem, Stevens-Johnsonov sindrom)
Depomedroxyprogesterone acetate (DMPA)/efavirenz (150 mg IM single dose DMPA)
Injekcija: Depomedroksiprogesteron acetat (DMPA)/efavirenz (150 mg IM jednostruka doza DMPA)
Each film-coated tablet contains 600 mg efavirenz.
Jedna filmom obložena tableta sadrži 600 mg efavirenza.
Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures.
U odraslih i pedijatrijskih bolesnika koji su uzimali efavirenz zabilježene su konvulzije i to obično u onih s napadajima u anamnezi.
- a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
simptomatske srčane aritmije u anamnezi ili klinički značajnu bradikardiju ili kongestivno zatajenje srca praćeno smanjenjem ejekcijske frakcije lijeve klijetke. teške poremećaje ravnoteže elektrolita, npr. hipokalijemiju ili hipomagnezemiju.
At baseline, median plasma HIV-1 RNA was 4.57 log10 copies/mL, median CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Na početku ispitivanja je medijan HIV-1 RNK u plazmi iznosio 4,57 log10 kopija/ml, medijan broja CD4+ stanica iznosio je 755 stanica/mm3, a medijan postotka CD4+ iznosio je 30%.
Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
zidovudin + lamivudin ili efavirenz + indinavir s kombinacijom indinavir + zidovudin + lamivudin u 1266 bolesnika koji prije ulaska u ispitivanje nisu primali efavirenz, lamivudin, NNRTI-je, niti inhibitore proteaze.
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