natgillin/translations-raw huggingface dataset:
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.
Bolniki z/s: - družinsko anamnezo nenadne smrti ali prirojenega podaljšanja intervala QTc na elektrokardiogramu ali s katerim koli drugim kliničnim stanjem, za katerega je znano, da podaljša interval QTc.
Efavirenz may remain in your blood for a time after therapy is stopped.
Efavirenz lahko ostane v krvi še nekaj časa po prenehanju zdravljenja.
A positive relationship between efavirenz concentration and QTc prolongation was observed.
Ugotovili so pozitivno povezavo med koncentracijo efavirenza in podaljšanjem intervala QTc.
Table 1: Paediatric dose to be administered once daily*
Preglednica 1: Pediatrični odmerki za uporabo enkrat na dan*
- severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
- huda oblika depresije - misel na samomor - samomorilni poskusi (ne smrtni) - agresivno vedenje - paranoidne reakcije - manične reakcije
Eighty-seven percent of patients had received prior antiretroviral therapy.
Sedeminosemdeset odstotkov bolnikov se je že prej zdravilo s protiretrovirusnimi zdravili.
This proportion is approximately 3-fold higher than the nonprotein-bound (free) fraction of efavirenz in plasma.
Ta delež je približno 3-krat višji od frakcije efavirenza v plazmi, ki ni vezana na beljakovine (prosta frakcija).
if you have severe liver disease.
če imate hudo bolezen jeter.
A causal relationship of these events to the use of efavirenz has not been established, and the denominator is unknown.
Vzročna povezava med temi dogodki in uporabo efavirenza ni bila ugotovljena in tudi skupni imenovalec ni znan.
You must not take SUSTIVA with certain medicines.
Zdravila SUSTIVA ne smete jemati skupaj z določenimi zdravili.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Znaki osteonekroze so togost sklepa, bolečnost in bolečine (zlasti v kolku, kolenu in rami) in težave z gibljivostjo.
Very common (affects more than 1 user in 10) skin rash
Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) kožni izpuščaj
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
Bolnikom je treba svetovati, naj se v primeru pojava simptomov, kot so huda oblika depresije, psihoza ali misel na samomor, nemudoma posvetujejo s svojim zdravnikom, ki bo ocenil, ali so simptomi lahko povezani z jemanjem efavirenza, in odločil, ali je tveganje nadaljevanja zdravljenja z efavirenzem večje od koristi (glejte poglavje 4.8).
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Kljub jemanju tega zdravila lahko še vedno s HIV okužite druge osebe, čeprav je tveganje zmanjšano z učinkovitim protiretrovirusnim zdravljenjem.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Bolnikom je treba naročiti, naj se v primeru teh simptomov izogibajo potencialno nevarnim opravilom, kakršna sta vožnja ali upravljanje strojev.
In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Pri bolnikih, ki se zdravijo z drugimi zdravili, ki so toksična za jetra, prav tako priporočamo spremljanje jetrnih encimov.
For children who are not able to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e.g., yogurt ).
Za otroke, ki ne morejo pogoltniti kapsul, lahko zdravnik priporoči, da odprete trdo kapsulo in njeno vsebino zmešate z majhno količino (1-2 kavni žlički) hrane (npr. jogurta).
Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Zdravnik bo morda naročil krvne teste, da bo preveril, kako dobro delujejo vaša jetra, ali pa vam bo zamenjal zdravilo.
Pharmacokinetic studies have not been performed in the elderly.
Farmakokinetičnih študij pri starejših bolnikih še niso opravili.
These immunosuppressants are not anticipated to affect exposure of efavirenz.
Pri teh imunosupresivih ne pričakujemo, da vplivajo na izpostavitev efavirenzu.
Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment.
V nosečnosti se efavirenza ne sme uporabljati, razen če zdravstveno stanje bolnice zahteva tovrstno zdravljenje.
Ketoconazole and other imidazole antifungals
ketokonazol in drugi imidazolski antimikotiki
The dose for adults is 600 mg once daily.
Odmerek za odrasle je 600 mg enkrat na dan.
How to take SUSTIVA 4.
Kako jemati zdravilo SUSTIVA 4.
Neither aluminium/magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Niti aluminijevi/magnezijevi hidroksidni antacidi niti famotidin niso spremenili absorpcije efavirenza.
Hypromellose (E464)
Hipromeloza (E464)
Although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Čeprav malo podatkov kaže, da je lahko tako pri ženskah kot pri bolnikih iz Azije ali s Pacifiških otokov izpostavljenost efavirenzu večja, izgleda da ti bolniki zdravila ne prenašajo nič slabše.
While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Čeprav potencialna karcinogenost za ljudi ni znana, podatki nakazujejo, da klinični učinek efavirenza odtehta možno tveganje za karcinogenost pri ljudeh.
two 200 mg capsules one 600 mg tablet OR three 200 mg capsules *For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2.
dve 200 mg kapsuli ena 600 mg tableta ALI tri 200 mg kapsule *Za informacije o biorazpoložljivosti vsebine kapsule, zmešane s hranilnim sredstvom, si oglejte poglavje 5.2.
It is recommended that efavirenz be taken on an empty stomach.
Priporoča se jemanje efavirenza na prazen želodec.
Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Glejte povzetek glavnih značilnosti zdravila, ki vsebuje maravirok.
Cholesterol levels should be periodically monitored.
Raven holesterola je treba periodično nadzorovati.
In particular, severe depression was more common in those with a history of depression.
Zlasti huda oblika depresije se je pojavljala bolj pogosto pri bolnikih z anamnezo depresije.
if you have a history of mental illness, including depression, or of substance or alcohol abuse.
če ste v preteklosti imeli duševno bolezen, vključno z depresijo, ali bili odvisni od substanc ali alkohola.
Psychiatric symptoms
Psihiatrični simptomi
Substantial decrease in lopinavir exposure.
Bistveno zmanjšanje izpostavljenosti lopinavirju.
Other medicines and SUSTIVA
Druga zdravila in zdravilo SUSTIVA
In these studies, efavirenz did not impair mating or fertility of male or female rats (doses up to 100 mg/kg/bid), and did not affect sperm or offspring of treated male rats (doses up to 200 mg/bid).
V teh študijah efavirenz ni škodil parjenju ali plodnosti podganjih samcev ali samic (odmerki do 100 mg/kg/dvakrat na dan) in ni vplival na spermo ali potomce zdravljenih podganjih samcev (odmerki do 200 mg/dvakrat na dan).
Nervous system symptoms
Simptomi živčnega sistema
Patients taking drugs that are known to prolong the QTc interval (proarrythmic).
Bolniki, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QTc (proaritmično delovanje).
The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Other medicines and SUSTIVA).
Odmerek zdravila SUSTIVA bo morda treba povečati ali zmanjšati v primeru, da jemljete še kakšna druga zdravila (glejte Druga zdravila in zdravilo SUSTIVA).
The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Mešanico je treba čimprej zaužiti, a ne pozneje kot 30 minut po pripravi.
The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Klinični izid zaznanih zmanjšanih koncentracij boceprevirja ni bil neposredno ocenjen.
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.
Izpostavitev efavirenzu se lahko poveča pri uporabi skupaj z zdravili (npr. z ritonavirjem) ali s hrano (npr. s sokom grenivke), ki zavirajo aktivnost CYP3A4 ali CYP2B6.
The clinical significance of asymptomatic increases in serum amylase is unknown.
Klinična pomembnost asimptomatskih zvišanj serumske amilaze ni znana.
Carbamazepine plasma levels should be monitored periodically.
Koncentracije karbamazepina v plazmi je treba periodično nadzorovati.
Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Zdravnik bo pri vas preveril vrednost holesterola in, če bo potrebno, spremenil odmerek statina.
Sertraline dose increases should be guided by clinical response.
Odmerek sertralina je treba povečati glede na klinični odziv.
This may stop the medicines from working properly, or may make any side effects worse.
To lahko prepreči pravilno delovanje zdravil ali poslabša neželene učinke.
The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Protiretrovirusna zdravila naj bolnik začne ponovno jemati istočasno, in sicer po odpravi simptomov intolerance.
Mean AUC(0-24) µM·h
Srednja vrednost AUC(0-24) µM·h
No dose recommendation can be made.
Priporočila za odmerjanje ni mogoče dati.
Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, coadministration of efavirenz and another NNRTI is not recommended.
Ker uporaba dveh zdravil NNRTI ni pokazala koristi glede učinkovitosti in varnosti, sočasne uporabe efavirenza in drugega zdravila NNRTI ne priporočamo.
Efficacy results for study 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 3.
Rezultate učinkovitosti študije 006 pri podskupini 614 bolnikov, vključenih vsaj 48 tednov, prikazuje preglednica 3.
6.5 Nature and content of container
6.5 Vrsta ovojnine in vsebina
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Če opazite kakršnekoli simptome okužbe ali druge simptome, na primer mišično oslabelost, oslabelost, ki se najprej pojavi v dlaneh in stopalih in nato širi proti trupu, palpitacije, tremor ali hiperaktivnost, zaradi potrebnega zdravljenja nemudoma obvestite zdravnika.
ATC code: J05AG03
Oznaka ATC: J05A G03
b C.I., confidence interval.
c IZ, interval zaupanja d
13 Stir to make sure there is no drug residue remaining in the container (illustration e).
13 Premešajte in se prepričajte, da v posodi ni ostankov zdravila (slika e).
The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Kategorija pogostnosti "redki" je bila opredeljena v skladu z navodili v smernici za Povzetek glavnih značilnosti zdravila (SmPC) (A Guideline on Summary of Product Characteristics, rev. 2., sep. 2009) na podlagi ocenjene zgornje meje 95-odstotnega intervala zaupanja za 0 dogodkov, upoštevajoč število oseb, zdravljenih z efavirenzem v teh kliničnih preskušanjih (n = 3.969).
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.
Zaradi dolgega razpolovnega časa efavirenza priporočamo uporabo ustrezne kontracepcije še 12 tednov po prekinitvi zdravljenja z efavirenzem.
Tests may show: increased cholesterol in the blood
Testi lahko pokažejo: povišane vrednosti holesterola v krvi
Efavirenz is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2) and not recommended in patients with moderate hepatic impairment because of insufficient data to determine whether dose adjustment is necessary.
Efavirenz je kontraindiciran pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 5.2), ne priporočamo pa ga bolnikom z zmerno okvaro jeter zaradi nezadostnih podatkov glede tega, ali je potrebno prilagoditi odmerek.
Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Do podobnih rezultatov so prišli tudi raziskovalci v drugi študiji, pri čemer pa so bile plazemske vrednosti MPA bolj spremenljive.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
As neural tube defects occur within the first 4 weeks of foetal development (at which time neural tubes are sealed), this potential risk would concern women exposed to efavirenz during the first trimester of pregnancy.
Ker pa okvare nevralne cevi nastanejo v prvih štirih tednih razvoja zarodka (ko se nevralna cev zapre), to možno tveganje zadeva samo ženske, ki so efavirenzu izpostavljene v prvem trimesečju nosečnosti.
Biliary fibrosis has been observed in rats.
Pri podganah so opažali biliarno fibrozo.
Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Študije karcinogenosti so pokazale povečano pojavnost jetrnih in pljučnih tumorjev pri mišjih samicah, ne pa pri mišjih samcih.
Five of these NNRTI-resistant isolates were found to have K103N or a valine-toisoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Pri petih od teh na NNRTI-je rezistentnih izolatov so našli substitucijo K103N ali substitucijo valin-v-izolevcin na položaju 108 (V108I) na RT. Trije od teh testiranih izolatov iz neuspešnega zdravljenja z efavirenzem so ostali občutljivi na efavirenz v celični kulturi in so bili občutljivi tudi na nevirapin in delavirdin.
If you have taken SUSTIVA or the combination tablet containing efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če zdravilo SUSTIVA ali kombinirane tablete, ki vsebujejo efavirenz, emtricitabin in tenofovir, jemljete med nosečnostjo, bo zdravnik morda naročil redne krvne preiskave in druge diagnostične teste za spremljanje razvoja otroka.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
7 Carefully pull the cap away from the body of the capsule (illustration c).
7 Previdno povlecite pokrovček s telesa kapsule (slika c).
15 Do not give the child any additional food for 2 hours.
15 Naslednji 2 uri otroku ne smete dati dodatne hrane.
Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease.
Večina primerov se je pojavila pri bolnikih, ki so že imeli bolezen jeter, nekaj primerov pa je bilo tudi pri bolnikih brez predhodne bolezni jeter.
It is recommended that the tablet be swallowed whole with water.
Priporočamo, da tableto pogoltnete celo, z vodo.
Study Number/ Treatment Regimensb n % (95% C.I.c)
Številka študije/ režimi zdravljenjab n % (95-odstotni IZc)
Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
antibiotiki, vključno z naslednjimi skupinami: makrolidi, fluorokinoloni ali imidazoli.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in pljučnica, povzročena s Pneumocystis jiroveci (nekoč znana kot Pneumocystis carinii).
The potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild type viral strains.
Učinkovitost efavirenza v celičnih kulturah proti virusnim različicam z aminokislinskimi substitucijami na mestih 48, 108, 179, 181 ali 236 na RT ali različicam z aminokislinskimi substitucijami na proteazi je bila podobna njegovi učinkovitosti proti divjim tipom virusnih sevov.
In addition, your doctor may prescribe a higher dose of SUSTIVA.
Poleg tega vam bo zdravnik morda predpisal večji odmerek zdravila SUSTIVA.
Study 020 showed similar activity in NRTI-experienced patients over 24 weeks.
Študija 020 je pri bolnikih, ki so se že zdravili z NRTI-ji, po 24 tednih pokazala podobno aktivnost.
2 Wash and dry your hands before and after preparing the capsule sprinkle.
2Pred pripravo posutja kapsule in po njej si umijte roke in jih osušite.
One child was reported to have a neural tube defect, and the frequency and pattern of other birth defects were similar to those seen in children exposed to non-efavirenz-containing regimens, as well as those in HIV negative controls.
Pri enem otroku so poročali o okvari nevralne cevi, pogostnost in vzorec drugih prirojenih napak pa sta bila podobna kot pri tistih otrocih, ki so bili izpostavljeni režimu zdravljenja brez efavirenza, in kot v kontrolnih skupinah, ki niso bile okužene s HIV.
if you are currently taking any of the following medicines (see also “Other medicines and Sustiva”):
če trenutno jemljete katero koli od naslednjih zdravil (glejte tudi "Druga zdravila in zdravilo Sustiva"):
Thirteen isolates previously characterised as efavirenz-resistant were also resistant to nevirapine and delavirdine.
Trinajst izolatov, ki so jih poprej označili kot rezistentne na efavirenz, je bilo rezistentnih tudi na nevirapin in delavirdin.
If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced.
Če jemljete hkrati obe zdravili, je treba odmerek vorikonazola povečati in odmerek efavirenza zmanjšati.
In some cases, your doctor may need to adjust your dose or check your blood levels.
V nekaterih primerih bo zdravnik morda moral prilagoditi odmerek ali preveriti količino zdravil v krvi.
No dose adjustment is necessary for any of these medicinal products.
Prilagoditev odmerka ni potrebna za nobeno od teh zdravil.
In the long-term study (006), 1% of patients in each treatment arm discontinued because of liver or biliary system disorders.
V dolgoročni študiji (006) je 1 % bolnikov v vsakem kraku prekinilo zdravljenje zaradi motenj v delovanju jeter, žolčnika ali žolčevodov.
SUSTIVA must be taken with other medicines that act against the HIV virus.
Zdravilo SUSTIVA je treba jemati skupaj z drugimi zdravili, ki delujejo proti virusu HIV.
Since no dose recommendation for itraconazole can be made, alternative antifungal treatment should be considered.
Ker za itrakonazol ni mogoče dati priporočila za odmerjanje, je treba pretehtati možnost uporabe drugega antimikotika.
A third isolate which carried a substitution at position 236 of RT was not cross-resistant to efavirenz.
Tretji izolat, s substitucijo na položaju 236 na RT, ni bil navzkrižno rezistenten na efavirenz.
uncommon hypercholesterolaemia*
občasni hiperholesterolemija*
Precautions to prevent transmission should be taken in accordance with national guidelines.
V skladu z nacionalnimi smernicami je treba uporabiti varnostne ukrepe za preprečevanje prenosa
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).
Efavirenz je nekompetitivni zaviralec reverzne transkriptaze (RT) HIV-1 in ne zavira pomembno RT HIV-2 ali celičnih polimeraz DNA (α, β, γ ali δ).
Based on this new data, the PRAC considers that the statement that the interaction between etonogestrel and efavirenz has not been studied is no longer valid and that this statement should be removed from the SmPC of all efavirenz-containing products.
Na podlagi teh novih podatkov odbor PRAC meni, da navedba, da medsebojnega delovanja etonogestrela in efavirenza niso preučili, ne drži več, zato je treba to navedbo odstraniti iz vseh povzetkov glavnih značilnosti zdravila za vsa zdravila, ki vsebujejo efavirenz.
Efavirenz has also been shown to induce UGT1A1.
Pokazalo se je, da efavirenz inducira tudi UGT1A1.
The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Ni znano, da bi taka povezava imela klinične posledice, vendar pa možnost za povečanje pogostnosti in resnosti z efavirenzem povezanih neželenih učinkov ne more biti izključena.
Carcinogenicity studies in male mice, male and female rats were negative.
Študije karcinogenosti pri mišjih samcih ter samcih in samicah podgan so bile negativne.
Concomitant administration of sofosbuvir/velpatasvir with efavirenz resulted in a reduction (approximately 50%) in the systemic exposure of velpatasvir.
Sočasna uporaba efavirenza in sofosbuvira/velpatasvira je povzročila zmanjšanje (približno 50-odstotno) sistemske izpostavljenosti velpatasviru.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo bolečine v sklepih, togost sklepov ali težave z gibljivostjo.
Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Zdravila za znižanje maščob v krvi (imenovana tudi statini): atorvastatin, pravastatin, simvastatin.
It is recommended that the capsule be swallowed whole with water.
Priporočamo, da kapsulo pogoltnete celo, z vodo.
Efavirenz plasma exposure may be increased in patients with the homozygous G516T genetic variant of the CYP2B6 isoenzyme.
Plazemska izpostavljenost efavirenza je lahko povečana pri bolnikih s homozigotno G516T genetsko različico izoencima CYP2B6.
Rare (affects 1 to 10 users in 10,000) itchy rash caused by a reaction to sunlight liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Redki (pojavijo se pri 1 do 10 od 10.000 bolnikov) srbeč izpuščaj, ki nastane zaradi reakcije na sonce odpoved jeter, ki je v določenih primerih smrtna ali vodi do presaditve jeter, se je pojavila pri uporabi efavirenza.
Cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Profili navzkrižne rezistence na efavirenz, nevirapin in delavirdin v celičnih kulturah so pokazali, da substitucija K103N povzroči izgubo občutljivosti na vse tri NNRTI-je.
FURTHER INFORMATION
DODATNE informacije