natgillin/translations-raw huggingface dataset:
Because of the limited information available, a reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Zbog ograničenosti dostupnih podataka, uz hormonske kontraceptive treba koristiti i pouzdanu mehaničku metodu kontracepcije (vidjeti dio 4.6).
Efavirenz: no clinically significant interaction.
Efavirenz: nema klinički značajnih interakcija.
Multipack: 90 (3 packs of 30 x 1) film-coated tablets
Višestruko pakiranje: 90 (3 pakiranja sa 30 x 1) filmom obloženih tableta
Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5).
Uvijek treba primjenjivati mehanička kontracepcijska sredstva u kombinaciji s drugim metodama kontracepcije (kao što su peroralni i drugi hormonski kontraceptivi, vidjeti dio 4.5).
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.
infekcijom (AIDS), koji su već imali oportunističke infekcije, znakovi i simptomi upale od prijašnjih infekcija mogu nastupiti ubrzo nakon početka anti-HIV liječenja.
Nervous system symptoms of moderate-to-severe intensity were experienced by 19% (severe 2%) of patients compared to 9% (severe 1%) of patients receiving control regimens.
Simptomi živčanog sustava umjerenog do jakog intenziteta zabilježeni su u 19% bolesnika (teški u 2%) koji su primali efavirenz, u odnosu na 9% bolesnika u kontrolnoj skupini (teški u 1%).
< 400 copies/ml (95% C.I.b)
< 400 kopija/ml (95% C.I.b)
The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Također, antiretrovirusne lijekove treba ponovo uvesti u kombiniranu terapiju istodobno s povlačenjem simptoma nepodnošenja lijeka.
Forty-three patients 3 months to 21 years of age (median 9.6 years) were dosed with efavirenz.
Četrdeset tri bolesnika u dobi od 3 mjeseca do 21 godinu (medijan 9,6 godina) primali su efavirenz.
Posaconazole:
Posakonazol:
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored.
Kada liječenje vorikonazolom završi, mora se ponovno dati početna doza efavirenza.
The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Istraživanja in vitro ukazuju da su CYP3A4 i CYP2B6 glavni izoenzimi uključeni u metabolizam efavirenza te da efavirenz inhibira P450 izoenzime 2C9, 2C19 i 3A4.
Protease inhibitor : Elbasvir/grazoprevir
Inhibitor proteaze: elbasvir/grazoprevir
One hundred two patients 3 months to 16 years of age (median 5.7 years) were treated with efavirenz.
Stotinu i dva bolesnika u dobi od 3 mjeseca do 16 godina (medijan 5,7 godina) liječeni su efavirenzom.
- itchy rash caused by a reaction to sunlight - liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
- osip koji svrbi uzrokovan reakcijom na Sunčevu svjetlost - kod primjene efavirenza nastupilo je zatajenje jetre, koje je u nekim slučajevima dovelo do smrti ili presađivanja jetre.
Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash.
Primjena odgovarajućih antihistaminika i/ili kortikosteroida može poboljšati podnošenje lijeka i ubrzati nestajanje osipa.
Efavirenz Teva film-coated tablets are not recommended for children under the age of 3 years or weighing less than 40 kg.
Efavirenz Teva filmom obložene tablete se ne preporučuju za djecu mlađu od 3 godine ili djecu tjelesne težine manje od 40 kg.
Pliva Hrvatska d.o.o.
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
NNRTIs/efavirenz
NNRTI/efavirenz
Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors.
Farmakoterapijska skupina: Antivirusni lijekovi za sistemsku primjenu; nenukleozidni inhibitori reverzne transkriptaze.
They include some common medicines and a herbal remedy (St. John's wort) which can cause serious interactions.
Obuhvaćaju neke često primjenjivane lijekove i biljni pripravak (gospinu travu) koji mogu izazvati ozbiljne interakcije.
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir-boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
inhibitore proteaze: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavirom pojačan atazanavir, sakvinavir ili fosamprenavir/sakvinavir.
Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Slične su rezultate dobili i drugi ispitivači, premda su razine MPA
Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Ispitivanja u ljudi i istraživanja in vitro na humanim jetrenim mikrosomima pokazala su da se efavirenz najvećim dijelom razgrađuje posredstvom sustava citokroma P450 do hidroksiliranih metabolita, nakon čega slijedi njihova glukuronidacija.
(CYP3A4 induction) * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
(indukcija CYP3A4) * u usporedbi s kombinacijom atazanavir 300 mg/ritonavir 100 mg jedanput na dan navečer, bez efavirenza.
Neither aluminium/magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Antacidi koji sadrže aluminijev/magnezijev hidroksid kao niti famotidin nisu mijenjali apsorpciju efavirenza.
<50 copies/ml (95% C.I.b)
<50 kopija /ml (95% C.I.b)
In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
U podskupini od 1008 odraslih bolesnika koji su u kontroliranim kliničkim ispitivanjima primali efavirenz u dozi od 600 mg na dan u kombinaciji s inhibitorima proteaze i/ili NRTI-ma najčešće nuspojave koje su bile najmanje umjerene težine i prijavljene u najmanje 5% bolesnika bile su: osip (11,6%), omaglica (8,5%), mučnina (8,0%),
See package leaflet for further information.
Opis odabranih nuspojava za detaljnije informacije.
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.
Ako je potrebno primjenjivati atazanavir istodobno s NNRTI-jem, može se razmotriti povišenje doze atazanavira na 400 mg i ritonavira na 200 mg, u kombinaciji s efavirenzom, pod pomnim kliničkim nadzorom.
It is recommended that efavirenz be taken on an empty stomach.
Preporučuje se efavirenz uzimati na prazan želudac.
Norbuprenorphine:
Norbuprenorfin:
No dose adjustment is necessary
Nije potrebno prilagođavati dozu
- skin rash
- kožni osip
No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of administered with efavirenz.
Nema utjecaja (↔) jednako smanjenje procjene srednje vrijednosti omjera od ≤20% ili povećanje procjene srednje vrijednosti omjera od ≤25%
Thirty-seven patients 3 months to 6 years of age (median 0.7 years) were treated with efavirenz.
Trideset sedmero bolesnika u dobi od 3 mjeseca do 6 godina (medijan 0,7 godina) liječeno je efavirenzom.
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents,
antiartimike skupina IA i III, neuroleptike, antidepresive,
Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
iznenadnu smrt ili kongenitalno produljenje QTc intervala na elektrokardiogramu u obiteljskoj anamnezi, ili bilo koje drugo kliničko stanje za koje je poznato da uzrokuje produljenje QTc intervala.
Uncommon Erythema multiforme, Stevens-Johnson syndrome* Rare
često pruritus manje često Erythema multiforme, Stevens-Johnsonov sindrom* rijetko fotoalergijski dermatitis†
A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
Slično smanjenje izloženosti indinaviru opaženo je kad se indinavir 1000 mg q8h primjenjivao s efavirenzom 600 mg na dan. (indukcija CYP3A4)
if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
o ako ste imali konvulzije (napadaje) ili se liječite antikonvulzivnim lijekovima kao što su karbamazepin, fenobarbital i fenitoin.
Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
Bilijarna hiperplazija opažena je kod cinomolgus majmuna koji su efavirenz primali ≥1 godine u dozama koje su postizale srednje vrijednosti AUC gotovo dvosruko veće od onih postignutih u ljudi, pri preporučenim dozama lijeka.
Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Pri prilagođavanju doze potrebno je uzeti u obzir individualnu podnošljivost i virološki odgovor (vidjeti dio 5.2).
When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics.
Pri propisivanju lijekova koji se primjenjuju istodobno s efavirenzom, liječnici trebaju proučiti sažetak opisa svojstava lijeka za te lijekove.
4-hydroxy atorvastatin:
4-hidroksi atorvastatin:
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.
Zbog dugog poluvijeka efavirenza, preporučuje se primjena odgovarajućih kontracepcijskih metoda tijekom 12
Artemether:
Artemeter:
When taken with rifampicin in patients weighing 50 kg or greater, increasing efavirenz daily dose to 800 mg may provide exposure similar to a daily dose of 600 mg when taken without rifampicin.
Kod istodobne primjene rifampicina u bolesnika tjelesne težine od 50 kg ili veće, povećanje dnevne doze efavirenza na 800 mg može imati sličnu izloženost kao kod primjene dnevne doze od 600 mg bez rifampicina.
In HIV infected patients at steady-state, mean Cmax, mean Cmin, and mean AUC were linear with 200 mg, 400 mg, and 600 mg daily doses.
U bolesnika zaraženih HIV-om, srednje vrijednosti Cmax, Cmin i AUC u stanju dinamičke ravnoteže bile su linearne pri dnevnim dozama od 200 mg, 400 mg i 600 mg.
Interaction not studied.
Nisu provedena ispitivanja interakcija.
Darunavir/ritonavir/efavirenz (300 mg twice daily*/100 mg twice daily/600 mg once daily) *lower than recommended doses, similar findings are expected with recommended doses
Darunavir/ritonavir/efavirenz (300 mg dvaput na dan*/100 mg dvaput na dan /600 mg jedanput na dan) * niža doza od preporučene, slični se rezultati očekuju s preporučenim dozama
- certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
pojedini antibiotici koji uključuju neke lijekove sljedećih skupina: makrolide, fluorokinolone;
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.
Geometrijska sredina Cmin indinavira (0,33 mg/l) kad se davao s ritonavirom i efavirenzom bila je viša od prosječne retrospektivne Cmin (0,15 mg/l) kad se indinavir davao sam u dozi od 800 mg q8h.
Other medicines and Efavirenz Teva You must not take Efavirenz Teva with certain medicines.
Efavirenz Teva ne smijete uzimati s određenim lijekovima.
Co-administration 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 adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Istodobna primjena s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ili ergot alkaloidima (primjerice ergotaminom, dihidroergotaminom, ergonovinom i metilergonovinom) zbog toga što kompeticija efavirenza za CYP3A4 može uzrokovati inhibiciju metabolizma i povećati mogućnost ozbiljnih i/ili po život opasnih nuspojava [npr. srčane aritmije, produžena sedacija ili respiratorna depresija] (vidjeti dio 4.5).
If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Ako bolesnik već uzima gospinu travu, mora prestati, te provjeriti razinu virusa i po mogućnosti koncentraciju efavirenza.
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.
Amilaza: u podskupini od 1008 bolesnika u kliničkom ispitivanju, opaženo je asimptomatsko povišenje vrijednosti amilaze u serumu više od 1,5 puta iznad gornje granice normale u 10% bolesnika liječenih efavirenzom i u 6% bolesnika u kontrolnom protokolu.
A causal relationship of these events to the use of efavirenz has not been established, and the denominator is unknown.
Uzročna veza ovih događaja s primjenom efavirenza nije utvrđena i nije poznat zajednički nazivnik.
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†
rijetko deluzije ‡, neuroza ‡, počinjeno samoubojstvo‡,* Poremećaji živčanog sustava često poremećaji cerebelarne koordinacije i ravnoteže†, poremećaji pažnje (3,6%), omaglica (8,5%), glavobolja (5,7%), somnolencija (2,0%)*
- The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core.
- Drugi sastojci u jezgri su mikrokristalična celuloza, hidroksipropilceluloza, natrijev laurilsulfat, natrijev škroboglikolat (tip A), poloksamer 407 i magnezijev stearat.
No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Nisu zabilježene malformacije fetusa kod ženki štakora i zečeva koje su primale efavirenz.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Ovakve su se reakcije obično javljale u prvih nekoliko tjedana ili mjeseci nakon uvođenja kombinirane antiretrovirusne terapije.
- Diltiazem or similar medicines (called calcium channel blockers which are medicines typically used for high blood pressure or heart problems): when you start taking Efavirenz
- Diltiazem ili slične lijekove (koji se zovu blokatori kalcijevih kanala, a to su lijekovi koji se obično primjenjuju kod povišenog krvnog tlaka ili srčanih tegoba): kad počnete uzimati Efavirenz Teva, liječnik će Vam možda trebati prilagoditi dozu blokatora kalcijevih kanala.
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.
Niže su navedene umjerene ili teže nuspojave kod kojih je ustanovljena barem moguća povezanost s protokolom liječenja (prema ocjeni ispitivača), a koje su zabilježene u kliničkim ispitivanjima s efavirenzom u preporučenim dozama u kombiniranoj terapiji (n=1008).
(Decrease in itraconazole concentrations: CYP3A4 induction)
(Snižena koncentracija itrakonazola: indukcija CYP3A4)
Anencephaly and unilateral anophthalmia 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.
U jednog fetusa opažene su anencefalija i unilateralna anoftalmija sa sekundarnim povećanjem jezika, u drugog je zabilježena mikrooftalmija, a u trećega rascjep nepca.
Interaction not studied
Nisu provedena ispitivanja interakcija
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (kao što su Gravesova bolest i autoimuni hepatits); međutim, prijavljeno vrijeme do pojave je različito i ti se događaji mogu javiti više mjeseci nakon uvođenja liječenja.
Always notify your doctor immediately if you have these symptoms or any side effects while taking Efavirenz Teva.
Odmah obavijestite svog liječnika ako se tijekom uzimanja Efavirenza Teva pojave opisani simptomi ili bilo koja druga nuspojava.
The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI: 22-33%) and 79% (90% CI: 58-102%), respectively, when given with a high-fat meal, relative to when given under fasted conditions (see section 4.4).
Nakon primjene jednokratne doze od 600 mg efavirenz filmom obloženih tableta s punomasnim obrokom u nezaraženih dobrovoljaca, AUC je porastao 28% (90% Cl: 22-33%), a Cmax 79% (90% Cl: 58-102%) u usporedbi s primjenom lijeka natašte (vidjeti dio 4.4).
Efavirenz Teva may make hormonal contraceptives less likely to work.
Efavirenz Teva može smanjiti djelotvornost hormonske kontracepcije.
Other macrolide antibiotics (e.g. erythromycin)/efavirenz
Drugi makrolidni antibiotici (npr. eritromicin)/efavirenz
Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended, as it may decrease concentrations of velpatasvir and voxilaprevir.
Istodobna primjena velpatasvira/sofosbuvira/voksilaprevir a s efavirenzom se ne preporučuje, jer može smanjiti koncentracije velpatasvira i voksilaprevira.
itraconazole.
itrakonazol.
Since efavirenz is highly protein-bound, dialysis is unlikely to remove significant quantities of it from blood.
Budući da se efavirenz u velikoj mjeri veže za proteine plazme, mala je vjerojatnost da bi se dijalizom uklonile značajne količine lijeka iz krvi.
This may make some side effects (for example, dizziness, drowsiness) less troublesome.
To može ublažiti neke nuspojave (npr. omaglicu, pospanost).
For a summary of clinical and pharmacodynamic information, see section 5.1.
Za sažetak kliničkih i farmakodinamičkih podataka vidjeti dio 5.1. 4.2 Doziranje i način primjene
if you have a history of mental illness, including depression, or of substance or alcohol abuse.
• Obavijestite svog liječnika: o ako ste bolovali od psihičkih bolesti, uključujući depresiju, ili ste bili ovisni o drogama ili alkoholu.
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
U bolesnika zaraženih HIV-om s teškim imunološkim deficitom pri uvođenju kombinirane antiretrovirusne terapije mogu se pojaviti upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, što može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
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 izboru novih antiretrovirusnih lijekova za kombiniranu primjenu s efavirenzom mora se misliti i na mogućnost razvoja virusne ukrižene rezistencije (vidjeti dio 5.1).
When efavirenz is co-administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Kod primjene efavirenza istodobno s antikonvulzivom koji je supstrat izoenzima CYP450, mora se periodički kontrolirati koncentracija antikonvulziva.
Contact your doctor or pharmacist for advice.
Posavjetujte se sa svojim liječnikom ili ljekarnikom.
Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Zabilježen je više nego stostruki gubitak osjetljivosti protiv onih HIV inačica koje su pored drugih zamjena aminokiselina u reverznoj transkriptazi imale i zamjenu K103N.
Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment.
Vidjeti u daljnjem tekstu i dio 5.3. Efavirenz se ne smije uzimati tijekom trudnoće, osim ako kliničko stanje bolesnice ne zahtijeva takvo liječenje.
Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
(primjerice ritonavirom) ili hranom (primjerice sokom od grejpa) koji inhibiraju djelovanje CYP3A4 ili CYP2B6.
(CYP3A4 induction) Efavirenz:
(indukcija CYP3A4) Efavirenz:
It is important to tell your doctor or pharmacist if you are taking any of the following: - Other medicines used for HIV infection:
Važno je da obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova:
The administration of efavirenz 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).
Primjena efavirenza s hranom može povećati izloženost efavirenzu (vidjeti dio 5.2) i povećati učestalost nuspojava (vidjeti dio 4.8).
Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Efavirenz se ne smije primjenjivati kao monoterapija u liječenju HIV-a niti se dodatkom samo efavirenza smije dopunjavati neučinkoviti režim liječenja.
If efavirenz is co-administered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered (see section 4.5).
Kod istodobne primjene s rifampicinom u bolesnika tjelesne težine od 50 kg ili veće može se razmotriti povećanje doze efavirenza na 800 m na dan (vidjeti dio 4.5).
What you need to know before you take Efavirenz Teva Do NOT take Efavirenz Teva
Što morate znati prije nego počnete uzimati Efavirenz Teva
Cellulose, microcrystalline Hydroxypropylcellulose Sodium laurilsulfate Sodium starch glycolate (Type A) Poloxamer 407
Jezgra celuloza, mikrokristalična hidroksipropilceluloza natrijev laurilsulfat natrijev škroboglikolat (tip A) poloksamer 407 magnezijev stearat
Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens.
Efavirenz još nije dovoljno ispitan u bolesnika s uznapredovalom bolesti HIV-a, kao primjerice u bolesnika s brojem CD4 < 50 stanica /mm3 ili nakon neuspjeha kombiniranog liječenja inhibitorima proteaze (IP).
d S.E.M., standard error of the mean.
d S.E.M., standardna pogreška srednje vrijednosti. ---, nije analizirano.
Package leaflet: information for the user Efavirenz Teva 600 mg film-coated tablets efavirenz
Uputa o lijeku: Informacija za korisnika Efavirenz Teva 600 mg filmom obložene tablete efavirenz
Caution must be taken in any patient with a history of seizures.
Potreban je oprez u svih bolesnika s napadajima u anamnezi.