natgillin/translations-raw huggingface dataset:
Packaging Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Blister (Alu) Bottle (HDPE) Bottle (HDPE) Blister (Alu) Bottle (HDPE) Blister (Alu) bottle (HDPE) bottle (HDPE)
plastenka (HDPE) pretisni omot (alu) plastenka (HDPE) pretisni omot (alu) plastenka (HDPE) plastenka (HDPE)
Package size 30 capsules 30 capsules 90 capsules 42 capsules 180 ml oral solution 60 tablets 60 tablets 30 tablets 30 tablets 30 tablets 90 tablets
60 tablets 60 tablet 30 tablet 30 tablet 30 tablet 90 tablet
Stocrin is a medicine that contains the active substance efavirenz.
Stocrinje zdravilo, ki vsebuje zdravilno učinkovino efavirenz.
It is available as capsules (yellow and white:
Na voljo je v kapsulah (rumenih in belih:
50 mg; white:
50 mg; belih:
100 mg; yellow:
100 mg; rumenih:
200 mg), as yellow, capsule-shaped tablets (600 mg), as round, yellow tablets (50 and 200 mg), and as an oral solution (30 mg/ ml).
200 mg), tabletah rumene barve v obliki kapsul (600 mg), v okroglih tabletah rumene barve (50 in 200 mg) ter v obliki peroralne raztopine (30 mg/ ml).
It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se skupaj z drugimi protivirusnimi zdravili pri zdravljenju odraslih in otrok, starih tri leta in več, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1), virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Treatment with Stocrin should be started by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Stocrin mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
It is recommended that Stocrin be taken on an empty stomach and without food, preferably at bedtime.
Priporočljivo je, da se zdravilo Stocrin jemlje na tešče, in sicer brez hrane, po možnosti pred spanjem.
The recommended dose of Stocrin for adults is 600 mg once a day.
Priporočeni odmerek zdravila Stocrin pri odraslih je 600 mg enkrat dnevno.
In patients aged three to 17 years, the dose depends on body weight.
Pri bolnikih, starih od 3 do 17 let, je odmerek odvisen od telesne mase.
For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution.
Pri bolnikih, ki kapsul ali tablet ne morejo pogoltniti, se zdravilo Stocrin lahko daje v obliki peroralne raztopine.
The dose of Stocrin needs to be reduced in patients taking voriconazole (used to treat fungal infections).
Odmerek zdravila Stocrin je treba zmanjšati pri bolnikih, ki jemljejo vorikonazol (zdravilo za zdravljenje glivičnih okužb).
Patients taking rifampicin (an antibiotic) may need to take a higher dose of Stocrin.
Pri bolnikih, ki jemljejo rifampicin (antibiotik), pa bo morda treba odmerek zdravila Stocrin povečati.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Za podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The active substance in Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Zdravilna učinkovina v zdravilu Stocrin, efavirenz, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Zavira aktivnost reverzne transkriptaze, encima, ki ga proizvaja virus HIV in ki omogoča okužbo celic v telesu in nastajanje novih virusov.
By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Stocrin, uporabljeno v kombinaciji z drugimi protivirusnimi zdravili, z blokiranjem tega encima zmanjša količino virusa HIV v krvi in ga ohranja na nizki ravni.
Stocrin does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Stocrin ne ozdravi okužbe s HIV ali AIDS- a, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS- om.
Stocrin has been studied in three main studies involving over 1,100 adults:  in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine;  the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin;  the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Zdravilo Stocrin so proučevali v okviru treh glavnih študij, ki so vključevale več kot 1 100 odraslih:  v prvi študiji so zdravilo Stocrin v kombinaciji z lamivudinom in zidovudinom ali z indinavirjem (drugimi protivirusnimi zdravili) primerjali s kombinacijo indinavirja, lamivudina in zidovudina;  v drugi študiji so zdravilo Stocrin v kombinaciji z nelfinavirjem primerjali z dvema drugima protivirusnima zdraviloma v isti kombinaciji, a brez zdravila Stocrin;  v tretji študiji so pri bolnikih, ki so se že zdravili zaradi okužbe z virusom HIV, primerjali dodajanje zdravila Stocrin ali placeba (zdravila brez zdravilne učinkovine) kombinaciji protivirusnih zdravil, ki so vključevala indinavir in dve drugi protivirusni zdravili.
Stocrin has also been studied in 57 children aged between three and 16 years, in combination with nelfinavir and other antiviral medicines.
Zdravilo Stocrin so v kombinaciji z nelfinavirjem in drugimi protivirusnimi zdravili proučevali tudi pri 57 otrocih, starih od tri do 16 let.
In all of the studies, the main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment.
V vseh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so imeli po 24 ali 48 tednih zdravljenja v krvi nezaznavno koncentracijo HIV- 1 (virusno breme).
All of the studies showed that combinations including Stocrin were at least as effective as the comparator medicines:  the first study showed that 67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;  in the second study, Stocrin in combination with nelfinavir was superior to the combination without Stocrin:
Vse študije so pokazale, da so bile kombinacije z zdravilom Stocrin vsaj tako učinkovite kot primerjalna zdravila:  prva študija pokazala, da je imelo 67% odraslih, zdravljenih z zdravilom Stocrin v kombinaciji z zidovudinom in lamivudinom, po 48 tednih virusno breme pod 400 kopij/ ml, v primerjavi s 54% bolnikov, zdravljenih z zdravilom Stocrin in indinavirjem, ter 45% bolnikov, zdravljenih z indinavirjem, lamivudinom in zidovudinom;  v drugi študiji je bilo zdravilo Stocrin v kombinaciji z nelfinavirjem učinkovitejše od kombinacije brez zdravila Stocrin:
70% and 30% of the patients, respectively, had viral loads below 500 copies/ ml after 48 weeks;  the third study showed that more patients receiving Stocrin had viral loads below 400 copies/ ml than those taking placebo after 24 weeks.
70% oziroma 30% bolnikov je imelo po 48 tednih zdravljenja virusna bremena pod 500 kopij/ ml;  tretja študija je po 24 tednih pokazala, da je bilo virusno breme pod 400 kopij/ ml pogostejše pri bolnikih, zdravljenih z zdravilom Stocrin, kot pri tistih, ki so prejemali placebo.
The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash.
Najpogostejši neželen učinek zdravila Stocrin (opažen pri več kot 1 bolniku od 10) so izpuščaji.
Stocrin is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Zdravilo Stocrin je povezano tudi s simptomi živčnega sistema, kot so omotica, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje, ter s psihiatričnimi motnjami, kot so huda depresija, samomorilno razmišljanje, poskusi samomora in agresivno obnašanje, zlasti pri bolnikih, ki so v preteklosti že imeli duševne motnje.
For a more complete list of side effects reported with Stocrin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stocrin, glejte navodilo za uporabo.
Stocrin should not be used in patients who may be hypersensitive (allergic) to efavirenz or any of the other ingredients.
Zdravila Stocrin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) efavirenz ali katero koli drugo sestavino zdravila.
It must not be used in patients with severe liver disease or who are taking any of the following medicines:  astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);  dihydroergotamine, ergotamine, ergonovine, methylergonovine (used to treat migraine headache);  midazolam, triazolam (used to relieve anxiety or difficulty sleeping);  pimozide (used to treat mental illnesses);  cisapride (used to relieve certain stomach problems);  bepridil (used to treat angina);  St John ’ s wort (a herbal preparation used to treat depression).
Ne smejo ga uporabljati bolniki z resnimi obolenji jeter ali osebe, ki jemljejo katero od naslednjih zdravil:  astemizol, terfenadin (pogosto se uporabljata za zdravljenje simptomov alergije – ti zdravili sta na voljo brez recepta),  dihidroergotamin, ergotamin, ergonovin, metilergonovin (uporabljajo se za zdravljenje migrenskega glavobola),  midazolam, triazolam (uporabljata se za lajšanje tesnobnosti ali težav s spanjem),  pimozid (uporablja se za zdravljenje duševnih bolezni),  cisaprid (uporablja se za lajšanje določenih želodčnih težav),  bepridil (uporablja se za zdravljenje angine),  šentjanževko (zeliščni pripravek, ki se uporablja za zdravljenje depresije).
See the Package Leaflet for further details.
Za več informacij glejte navodilo za uporabo.
As with other anti-HIV medicines, patients taking Stocrin may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki jemljejo zdravilo Stocrin, nevarnost lipodistrofije (sprememb v porazdelitvi telesnega maščevja), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem, medtem ko se zdravi).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Stocrin.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravila Stocrin povečano tveganje za poškodbe jeter.
2/ 3 Why has Stocrin been approved?
2/ 3 Zakaj je bilo zdravilo Stocrin odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Stocrin’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Stocrin pri protivirusnem kombiniranem zdravljenju odraslih, mladostnikov in otrok, starih tri leta ali več, okuženih z virusom HIV, večje od z njim povezanih tveganj.
The Committee noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Odbor je ugotovil, da zdravilo Stocrin ni bilo ustrezno raziskano pri bolnikih z napredovalo boleznijo (število celic CD4 pod 50 celic/ mm3) ali po zdravljenju z zaviralci proteaze (drugo vrsto protivirusnega zdravila), ki ni bilo uspešno.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Odbor je poleg tega ugotovil, da obstaja malo informacij o koristih zdravljenja z zaviralci proteaze pri bolnikih, ki so bili v preteklosti zdravljeni z zdravilom Stocrin, ki je čez čas postalo neučinkovito, čeprav ni dokazov, da zaviralci proteaze pri teh bolnikih ne bi bili učinkoviti.
The Committee recommended that Stocrin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Stocrin odobri dovoljenje za promet.
Other information about Stocrin:
Druge informacije o zdravilu Stocrin:
The European Commission granted a marketing authorisation valid throughout the European Union for Stocrin to Merck Sharp & Dohme Limited on 28 May 1999.
Imetnik dovoljenja za promet je družba Bristol- Myers Squibb Pharma EEIG.
The marketing authorisation was renewed on 28 May 2004 and on 28 May 2009.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 28. maja 2004 in 28. maja 2009.
The full EPAR for Stocrin can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Stocrin je na voljo tukaj.
This summary was last updated in 05-2009.
Povzetek je bil nazadnje posodobljen 05- 2009.
Excipient: each hard capsule contains 28.5 mg of lactose monohydrate.
Pomožne snovi: ena trda kapsula vsebuje 28. 5 mg laktoze monohidrata.
Dark yellow and white, printed with “ 3805”.
Trde kapsule so temno rumene in bele barve in imajo napis » 3805 «.
STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
4. 1 Terapevtske indikacije
STOCRIN 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.
Uporabe zdravila STOCRIN še niso dovolj preučili pri bolnikih z napredovano boleznijo HIV, to je pri bolnikih z vrednostjo CD4 < 50 celic/ mm3, ali po neuspelem zdravljenju z režimom, ki je vključeval zaviralce proteaze (ZP).
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Čeprav navzkrižna rezistenca efavirenza z ZP ni dokumentirana, trenutno nimamo dovolj podatkov o učinkovitosti uporabe kombiniranega zdravljenja, ki vključuje ZP, po neuspelem zdravljenju z režimom, ki je vključeval tudi STOCRIN.
For a summary of clinical and pharmacodynamic information, see section 5.1.
Za povzetek kliničnih in farmakodinamičnih informacij glejte poglavje 5. 1.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje mora uvesti zdravnik z izkušnjami pri zdravljenju okužbe HIV.
Concomitant antiretroviral therapy:
Sočasno protiretrovirusno zdravljenje:
STOCRIN must be given in combination with other antiretroviral medicines (see section 4.5).
STOCRIN je treba dajati v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4. 5).
It is recommended that STOCRIN be taken on an empty stomach.
Priporočamo, da se STOCRIN jemlje na prazen želodec.
The increased efavirenz concentrations observed following administration of STOCRIN 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 zdravila STOCRIN s hrano, lahko vodi do povečane pogostosti neželenih učinkov (glejte poglavji 4. 4 in 5. 2).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended (see section 4.8).
Da bi bolniki bolje prenašali neželene učinke na živčni sistem, priporočamo 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 600 mg orally, once daily.
V kombinaciji z nukleozidnimi zaviralci revezne transkriptaze (NRTI- ji), z ali brez ZP, je priporočeni odmerek efavirenza 600 mg peroralno, enkrat dnevno (glejte poglavje 4. 5).
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN 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 zdravila STOCRIN za bolnike stare od 3 do 17 let naveden v Preglednici 1.
STOCRIN hard capsules must only be administered to children who are able to reliably swallow hard capsules.
STOCRIN trde kapsule smemo dati le otrokom, ki so trde kapsule zmožni pogoltniti.
2 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).
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.).
Table 1 Paediatric dose to be administered once daily
Pediatrični odmerki za uporabo enkrat dnevno
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
13 do < 15 15 do < 20 20 do < 25
Dosage adjustment: if STOCRIN is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the STOCRIN dose must be reduced by 50%, i. e., to 300 mg once daily.
Prilagoditev odmerjanja: če se STOCRIN uporablja hkrati z vorikonazolom je treba vzdrževalni odmerek vorikonazola povečati na 400 mg na 12 ur, odmerek zdravila STOCRIN pa zmanjšati za 50%, to je na 300 mg enkrat dnevno.
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see section 4.5).
Ko je zdravljenje z vorikonazolom končano, je potrebno ponovno uvesti začetni odmerek efavirenza (glejte poglavje 4. 5).
If STOCRIN is coadministered with rifampicin, an increase in the dose of STOCRIN to 800 mg/ day may be considered (see section 4.5).
Če se STOCRIN uporablja skupaj z rifampicinom, je priporočljivo pretehtati možnost povečanja odmerka zdravila STOCRIN na 800 mg dnevno (glejte poglavje 4. 5).
Renal impairment: 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).
Hepatic impairment: patients with mild to moderate liver disease may be treated with their normally recommended dose of efavirenz.
Bolnike z blago do zmerno jetrno boleznijo se lahko zdravi z njihovim običajnim priporočenim odmerkom efavirenza.
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Bolnike je treba pozorno spremljati zaradi možnih od odmerka odvisnih neželenih učinkov, še posebej tistih, ki so povezani z živčnim sistemom (glejte poglavji 4. 3 in 4. 4).
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali za katerokoli od pomožnih snovi.
Efavirenz must not be used in patients with severe hepatic impairment (Child Pugh Grade C) (see section 5.2).
Efavirenza ne smejo jemati bolniki s hudo okvaro jeter (stopnja C po Child Pugh- ovi skali) (glejte poglavje 5. 2).
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, 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).
John’ s wort (Hypericum perforatum) must not be used while taking efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), bolniki, ki prejemajo efavirenz, ne smejo uporabljati zaradi nevarnosti znižanja plazemske koncentracije in zmanjšanja kliničnega učinka efavirenza (glejte poglavje 4. 5).
Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Efavirenza ne smemo uporabljati kot samostojno zdravilo za zdravljenje HIV, prav tako ga ne smemo uporabiti kot edino zdravilo pri neuspelemu režimu zdravljenja.
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Če se efavirenz uporablja kot monoterapija, se tako kot pri vseh drugih nenukleozidnih zaviralcih reverzne transkriptaze (NNRTI - jih) lahko hitro pojavi rezistentni virus.
The choice of new antiretroviral agent(s) to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance (see section 5.1).
Pri izbiri novega protiretrovirusnega zdravila (ali več takih zdravil) za uporabo v kombinaciji z efavirenzem je treba upoštevati možnost pojava navzkrižne virusne rezistence (glejte poglavje 5. 1).
3 Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
3 Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in tenofovirdizoproksilfumarat, ne priporočamo.
When prescribing medicinal products concomitantly with STOCRIN, physicians should refer to the corresponding Summary of Product Characteristics.
Pri predpisovanju zdravil, ki se jemljejo hkrati z zdravilom STOCRIN, mora zdravnik upoštevati ustrezni Povzetek glavnih značilnosti zdravila.
Patients should be advised that current antiretroviral therapy, including efavirenz, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Bolnika je treba seznaniti s tem, da za sedanje protiretrovirusno zdravljenje, vključno z zdravljenjem z efavirenzem, ni bilo dokazano, da bi preprečevalo nevarnost prenosa virusa HIV na druge osebe s spolnimi odnosi ali z okuženo krvjo.
Appropriate precautions should continue to be employed.
Še naprej mora uporabljati ustrezno zaščito.
Rash: mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
V kliničnih raziskavah z efavirenzem so poročali o blagem do zmernem izpuščaju, ki je pri nadaljnjem zdravljenju običajno izginil.