natgillin/translations-raw huggingface dataset:
Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
Niti emtricitabin niti tenofovir in vitro nista zavirala presnavljanja zdravil, ki se biotransformirajo s katerokoli od pomembnejših glavnih izooblik humanega CYP450.
Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Emtricitabin prav tako ni zaviral uridin- 5 '- difosfoglukuronil- transferaze, encima, ki je odgovoren za glukuronidacijo.
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Izločanje: efavirenz ima relativno dolg končni razpolovni čas, vsaj 52 ur po enkratnem odmerku (glejte tudi podatke iz bioekvivalenčne študije, opisane zgoraj) in 40 do 55 ur po večkratnih odmerkih.
Approximately 14 to 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Približno 14- 34% radioaktivno označenega odmerka efavirenza se je izločilo z urinom, manj kot 1% odmerka pa se je z urinom izločilo v obliki nespremenjenega efavirenza.
Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Emtricitabin se primarno izloča skozi ledvica – celoten odmerek se izloči z urinom (približno 86%) in blatom (približno 14%).
Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
13% odmerka emtricitabina so odkrili v urinu v obliki treh presnovkov.
The systemic clearance of emtricitabine averaged 307 ml/ min.
Sistemski očistek emtricitabina je v povprečju 307 ml/ min.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Tenofovir se primarno izloča skozi ledvica tako z glomerulno filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenskem vnosu približno 70- 80% odmerka izloči nespremenjenega z urinom.
Renal
Povprečni navidezni očistek tenofovirja je znašal približno 307 ml/ min.
30 clearance has been estimated to be approximately 210 ml/ min, which is in excess of the glomerular filtration rate.
Ocenili so, da znaša ledvični očistek približno 210 ml/ min, kar presega stopnjo glomerularne filtracije.
Age, gender and ethnicity: the pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Starost, spol in etnična pripadnost: farmakokinetične lastnosti emtricitabina in tenofovirja so podobne pri bolnikih moškega in ženskega spola.
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 pomanjkljivi podatki kažejo, da je lahko pri bolnikih ženskega spola in pri bolnikih iz Azije ali s Pacifiških otokov izpostavljenost efavirenzu večja, ne kaže, da bi le- ti zdravilo prenašali slabše.
Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in the elderly (over 65 years).
Farmakokinetične študije z efavirenzom, emtricitabinom ali tenofovirjem niso bile izvedene pri starejših bolnikih (nad 65 let).
Pharmacokinetic studies with Atripla have not been performed in infants and children (see section 4.2).
Farmakokinetičnih študij z zdravilom Atripla pri dojenčkih in otrocih niso opravili (glejte poglavje 4. 2).
Renal impairment: the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil fumarate after co-administration of the separate pharmaceutical forms or as Atripla have not been studied in HIV infected patients with renal impairment.
Ledvična okvara: farmakokinetike efavirenza, emtricitabina in tenofovirdizoproksil fumarata po sočasnem jemanju ločenih farmacevtskih oblik ali v obliki zdravila Atripla niso raziskovali pri bolnikih, okuženih z virusom HIV, ki imajo ledvično okvaro.
Pharmacokinetic parameters were determined following administration of single doses of the individual preparations of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Farmakokinetične parametre so določili po uporabi enkratnih odmerkov 200 mg emtricitabina ali 245 mg tenofovirdizoproksila pri bolnikih, ki niso bili okuženi s HIV, z različnimi stopnjami ledvične okvare.
The degree of renal impairment was defined according to baseline creatinine clearance (normal renal function when creatinine clearance > 80 ml/ min; mild impairment with creatinine clearance=50 to 79 ml/ min; moderate impairment with creatinine clearance=30 to 49 ml/ min and severe impairment with creatinine clearance=10 to 29 ml/ min).
Stopnja ledvične okvare je bila opredeljena glede na začetno vrednost kreatininskega očistka (ClCr) (normalno delovanje ledvic je pri kreatininskem očistku ClCr > 80 ml/ min, blaga okvara pri ClCr = 50- 79 ml/ min, zmerna okvara pri ClCr = 30- 49 ml/ min, huda okvara pa pri ClCr = 10- 29 ml/ min).
The mean (%CV) emtricitabine exposure increased from 12 µg• h/ ml (25%) in subjects with normal renal function to 20 µg• h/ ml (6%), 25 µg• h/ ml (23%) and 34 µg• h/ ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Srednja vrednost (% CV) izpostavljenosti emtricitabinu se je zvišala od 12 µg• h/ ml (25%) pri bolnikih z normalnim delovanjem ledvic na 20 µg• h/ ml (6%) pri bolnikih z blago ledvično okvaro, na 25 µg• h/ ml (23%) pri bolnikih z zmerno ledvično okvaro ter na 34 µg• h/ ml (6%) pri bolnikih s hudo ledvično okvaro.
The mean (%CV) tenofovir exposure increased from 2,185 ng• h/ ml (12%) in patients with normal renal function, to 3,064 ng• h/ ml (30%), 6,009 ng• h/ ml (42%) and 15,985 ng• h/ ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Srednja vrednost (% CV) izpostavljenosti tenofovirju se je zvišala od 2, 185 µg• h/ ml (12%) pri bolnikih z normalnim delovanjem ledvic na 3, 064 µg• h/ ml (30%) pri bolnikih z blago ledvično okvaro, na
In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg• h/ ml (19%) of emtricitabine, and over 48 hours to 42,857 ng• h/ ml (29%) of tenofovir.
Pri bolnikih s končno fazo ledvične bolezni (end- stage renal disease – ESRD), pri katerih je potrebna hemodializa, se je izpostavljenost zdravilu med dializami močno povečala v obdobju 72 ur na 53 µg• h/ ml (19%) emtricitabina, v obdobju 48 ur pa na 42, 857 ng• h/ ml (29%) tenofovirja.
However, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on exposure to efavirenz is likely to be minimal.
Vendar pa se manj kot 1% odmerka efavirenza izloči nespremenjenega v urinu, zato je verjetno vpliv ledvične okvare na izpostavljenost efavirenzu minimalen.
Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/ min).
Uporaba zdravila Atripla pri bolnikih z zmerno ali hudo ledvično insuficienco (kreatininski očistek < 50 ml/ min) ni priporočljiva.
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.2 and 4.4).
Pri bolnikih z zmerno ali hudo ledvično insuficienco je potrebna prilagoditev intervala odmerjanja emtricitabina in tenofovirdizoproksil fumarata, ki je ni mogoče doseči s kombinirano tableto (glejte poglavji 4. 2 in 4. 4).
Hepatic impairment: the pharmacokinetics of Atripla have not been studied in HIV infected patients with hepatic impairment.
Jetrna okvara: farmakokinetike zdravila Atripla pri bolnikih, okuženih z virusom HIV, ki imajo jetrno okvaro, niso raziskovali.
Atripla should be administered with caution to patients with mild-to-moderate liver disease (see sections 4.3 and 4.4).
Pri bolnikih z blago do zmerno jetrno boleznijo je treba zdravilo Atripla uporabljati previdno (glejte poglavji 4. 3 and 4. 4).
Atripla must not be used in patients with severe hepatic impairment (see section 4.3).
Zdravilo Atripla se ne sme uporabljati pri bolnikih s hudo jetrno okvaro (glejte poglavje 4. 3).
In the single patient studied with severe hepatic impairment (CPT, Grade C), half-life of efavirenz was doubled indicating a potential for a much greater degree of accumulation.
Pri edinem bolniku, ki je sodeloval v študiji, s hudo jetrno okvaro (stopnje C po lestvici CPT) se je razpolovni čas efavirenza podvojil, kar kaže, da obstaja možnost veliko večje stopnje akumulacije.
31 The pharmacokinetics of emtricitabine have not been studied in non-HBV infected patients with varying degrees of hepatic insufficiency.
Farmakokinetike emtricitabina niso raziskovali pri bolnikih z različnimi stopnjami jetrne insuficience, ki niso okuženi z virusom HBV.
A single 300 mg dose of tenofovir disoproxil fumarate was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
Bolnikom brez okužbe z virusom HIV z različnimi stopnjami jetrne okvare po klasifikaciji CPT so dali 300- miligramski odmerek tenofovirdizoproksil fumarata.
Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment of tenofovir disoproxil fumarate is required in these subjects.
Farmakokinetika tenofovirja se pri osebah z jetrno okvaro ni bistveno spremenila, kar nakazuje, da pri teh osebah ni treba prilagoditi odmerjanja tenofovirdizoproksil fumarata.
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.
Malformacije so opazili pri 3 od 20 opičjih zarodkov/ novorojencev vrste Cynomolgus, ki so prejemali odmerke, s katerimi so dosegli plazemske koncentracije efavirenza, podobne tistim pri človeku.
Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, micro-ophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Pri enem zarodku so opazili anencefalijo in unilateralno anoftalmijo s sekundarno povečanim jezikom, pri drugem mikrooftalmijo, pri tretjem pa razcepljeno nebo.
Efavirenz induced foetal resorptions in rats.
Efavirenz je sprožil resorpcijo fetusov pri podganah.
No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Pri zarodkih podgan in kuncev, ki so prejemali efavirenz, niso opazili malformacij.
Conventional reproductive/ developmental toxicity studies with emtricitabine and tenofovir disoproxil fumarate revealed no special hazard for humans.
Običajne študije reproduktivne in razvojne toksičnosti z emtricitabinom in tenofovirdizoproksil fumaratom niso pokazale posebnega tveganja za človeka.
Carcinogenicity studies using efavirenz showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Študije kancerogenosti so pokazale povečanje incidence jetrnih in pljučnih tumorjev pri mišjih samicah, ne pa tudi pri mišjih samcih.
Carcinogenicity studies using efavirenz in male mice and in male and female rats were negative.
Študije kancerogenosti efavirenza pri mišjih samcih ter podganjih samcih in samicah so bile negativne.
While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Morebitna kancerogenost pri človeku ni znana, vendar podatki nakazujejo, da klinični učinek efavirenza odtehta možno tveganje za kancerogenost pri človeku.
Tenofovir disoproxil fumarate did not show any carcinogenic potential in a long-term oral carcinogenicity study in rats.
37 Tenofovirdizoproksil fumarat ni pokazal kancerogenega potenciala v dolgotrajni študiji kancerogenosti na podganah po peroralnem dajanju učinkovine.
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
Dolgoročna raziskava kancerogenosti na miših po peroralnem dajanju je pokazala nizko incidenco tumorjev na dvanajstniku, ki so verjetno povezani z visokimi lokalnimi koncentracijami v prebavilih pri odmerku 600 mg/ kg/ dan.
While the mechanism of tumour formation is uncertain, the findings are unlikely to be of relevance to humans.
Čeprav mehanizem nastanka tumorjev ni gotov, te ugotovitve za človeka verjetno niso pomembne.
Emtricitabine did not show any carcinogenic potential in long-term studies in rats and mice.
Emtricitabin ni pokazal kancerogenega potenciala v dolgoročnih študijah na podganah in miših.
Efavirenz and emtricitabine were negative in conventional genotoxic assays.
Efavirenz in emtricitabin sta bila pri običajnih preskusih genotoksičnosti negativna.
Tenofovir disoproxil fumarate was positive in two out of three in vitro genotoxicity studies but negative in the in vivo micronucleus assay.
Tenofovirdizoproksil fumarat je bil pozitiven v dveh od treh študijah genotoksičnosti in vitro, vendar je bil negativen pri testu mikronukleusa in vivo.
The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
Kombinacija emtricitabina in tenofovirdizoproksil fumarata je bila pozitivna pri testu mišjega limfoma in vitro, rezultati pa so bili primerljivi s tistimi, ki so jih pridobili za sam tenofovirdizoproksil fumarat.
The combination of emtricitabine and tenofovir disoproxil fumarate was negative in the bacterial reverse mutation assay (Ames assay).
Kombinacija emtricitabina in tenofovirdizoproksil fumarata je bila negativna pri bakterijskem testu reverzne mutacije (Amesov test).
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.
Pri opicah Cynomolgus, ki so jim ≥ 1 leto dajali efavirenz v odmerkih, s katerimi so dosegli približno 2- krat večjo povprečno vrednost AUC kakor pri ljudeh, ki so prejemali priporočeni odmerek, so opazili biliarno hiperplazijo.
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Pri nekaterih opicah, ki so prejemale efavirenz ≥ 1 leto, so opazili prehodne konvulzije pri uporabi odmerkov, s katerimi so dosegli od 4 - do 13- krat večje vrednosti AUC kot pri ljudeh, ki so prejemali priporočene odmerke (glejte poglavji 4. 4 in 4. 8).
Preclinical studies of tenofovir disoproxil fumarate conducted in rats, dogs and monkeys revealed effects on bone and a decrease in serum phosphate concentration.
Predklinične študije tenofovirdizoproksil fumarata, opravljene na podganah, psih in opicah, so pokazale učinke na kosteh in znižanje koncentracije serumskega fosfata.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Ugotovitve študij, opravljenih na podganah in opicah, so pokazale z učinkovino povezano zmanjšanje absorpcije fosfata v črevesju s potencialnim sekundarnim zmanjšanjem mineralne gostote kosti.
The mechanisms of these toxicities are not completely understood.
Mehanizmi teh toksičnosti še niso popolnoma znani.
32 A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate found no exacerbation of toxicological effects compared to the separate components.
Uporaba kombinacije emtricitabina in tenofovirdizoproksil fumarata v enomesečni študiji na psih ni pokazala poslabšanja toksikoloških učinkov v primerjavi z uporabo ločenih učinkovin.
Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate
Jedro tablete: premreženi natrijev karmelozat hidroksipropilceluloza magnezijev stearat mikrokristalna celuloza natrijev lavrilsulfat
Iron oxide black Iron oxide red Macrogol 3350 Poly(vinyl alcohol) Talc Titanium dioxide
Filmska obloga: črni železov oksid rdeči železov oksid makrogol 3350 polivinilalkohol smukec titanov dioksid
6.2 Incompatibilities
38 6. 2 Inkompatibilnosti
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.
Steklenička iz polietilena velike gostote (HDPE) s polipropilensko za otroke varno zaporko, ki vsebuje 30 filmsko obloženih tablet in sušilo iz silikagela.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
Na voljo so naslednje velikosti pakiranj: škatle z 1 stekleničko ali s 3 stekleničkami po 30 filmsko obloženih tablet.
Dublin Ireland
Dublin Irska
34 ANNEX II
39 DODATEK II
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije:
Cork Ireland
Cork Irska
The MAH shall ensure that additional risk minimisation activities to address the renal safety concerns related to tenofovir disoproxil fumarate, one of the active substances contained in Atripla, are being implemented for this fixed combination like for all medicinal products containing tenofovir disoproxil fumarate.
Imetnik dovoljenja za promet mora zagotoviti implementacijo dodatnih ukrepov za zmanjšanje tveganja ob uporabi obstoječe fiksne kombinacije učinkovin kot pri vseh zdravilih, ki vsebujejo tenofovirdizoproksil fumarat, ter tako skrbeti za morebitne neželene učinke na ledvica, povezane s tenofovirdizoproksil fumaratom, ki je ena izmed učinkovin zdravila Atripla.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 (28/ 02/ 2008) and included in the Type II variation (EMEA/ H/ C/ 000797/ II/ 0003) is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora pred pričetkom trženja zdravila vzpostaviti delujoči sistem farmakovigilance, kot je opisan v različici 2. 0 (28/ 02/ 2008) in vključen v spremembo tipa II (EMEA/ H/ C/ 000797/ II/ 0003), in ga vzdrževati ves čas trženja zdravila.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 (February 2008) of the Risk Management Plan (RMP) presented with the first PSUR and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3 (februar 2008) načrta obvladovanja tveganja (RMP), predstavljenega v prvem rednem dopolnjenem poročilu o varnosti zdravila (PSUR), in vse naknadne dopolnitve načrta obvladovanja tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
41 V skladu s smernicami Odbora za zdravila za uporabo v humani medicini (CHMP) o sistemih obvladovanja tveganja za zdravila za uporabo v humani medicini je treba dopolnjen načrt obvladovanja tveganja predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
36 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je dopolnjen načrt obvladovanja tveganja treba predložiti: • ko se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali aktivnosti za zmanjšanje tveganja. • v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja). • na zahtevo Evropske agencije za zdravila (EMEA).
37 ANNEX III
42 DODATEK III
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
44 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
BOTTLE AND CARTON LABELLING
OZNAKE NA STEKLENIČKI IN ŠKATLI
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets efavirenz, emtricitabine and tenofovir disoproxil
Atripla 600 mg/ 200 mg/ 245 mg filmsko obložene tablete efavirenz, emtricitabin in tenofovirdizoproksil
Contains sodium.
Zdravilo vsebuje natrij.
30 film-coated tablets 3 x 30 film-coated tablets
3 x 30 filmsko obloženih tablet.
EU/ 1/ 07/ 430/ 001 30 film-coated tablets EU/ 1/ 07/ 430/ 002 3 x 30 film-coated tablets
EU/ 1/ 07/ 430/ 001 30 filmsko obloženih tablet EU/ 1/ 07/ 430/ 002 3 x 30 filmsko obloženih tablet
INFORMATION FOR THE USER
47 NAVODILO ZA UPORABO
What Atripla is and what it is used for 2.
Kaj je zdravilo Atripla in za kaj ga uporabljamo 2.
Before you take Atripla 3.
Kaj morate vedeti, preden boste vzeli zdravilo Atripla 3.
How to take Atripla 4.
Kako jemati zdravilo Atripla 4.
How to store Atripla 6.
Shranjevanje zdravila Atripla 6.
WHAT ATRIPLA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ATRIPLA IN ZA KAJ GA UPORABLJAMO
- Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
- efavirenz je nenukleozidni zaviralec reverzne transkriptaze (non- nucleoside reverse transcriptase
- Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
- emtricitabin je nukleozidni zaviralec reverzne transkriptaze (nucleoside reverse transcriptase
- Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
- tenofovir je nukleotidni zaviralec reverzne transkriptaze (nucleotide reverse transcriptase inhibitor
Atripla is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
Zdravilo Atripla je namenjeno zdravljenju okužbe z virusom humane imunske pomanjkljivosti (HIV) pri odraslih bolnikih, starih 18 let ali več, ki so bili predhodno zdravljeni z drugimi protiretrovirusnimi zdravili in pri katerih je okužba z virusom HIV- 1 nadzorovana vsaj tri mesece.
BEFORE YOU TAKE ATRIPLA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ATRIPLA
Do not take Atripla
Ne jemljite zdravila Atripla
- if you are allergic (hypersensitive) to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil
- če ste alergični na (preobčutljivi za) efavirenz, emtricitabin, tenofovir, tenofovirdizoproksil
fumarate, or any of the other ingredients of Atripla listed at the end of this leaflet.
fumarat ali katerokoli sestavino zdravila Atripla, navedeno na koncu tega navodila.
- if you are currently taking any of the following medicines:
- če trenutno jemljete katerokoli od naslednjih zdravil:
astemizole or terfenadine (used to treat hay fever or other allergies) bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
astemizol ali terfenadin (uporabljata se za zdravljenje senenega nahoda in drugih alergij), bepridil (uporablja se za zdravljenje bolezni srca), cisaprid (uporablja se za zdravljenje zgage), alkaloidi rženih rožičkov (na primer ergotamin, dihidroergotamin, ergonovin in metilergonovin) (uporabljajo se za zdravljenje migren in glavobolov v rafalih),