natgillin/translations-raw huggingface dataset:
At baseline, median plasma HIV-1 RNA was 4.57 log10 copies/mL, median CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Ob izhodišču je ugotovljeno: mediana plazemsko HIV-1 RNA je bila 4,57 log10 kopij/ml, mediana števila celic CD4+ je bila 755 celic/mm3 in mediana odstotka CD4+ je bila 30 %.
In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
(vrednost meritve pred ali za njo pa je bila nad mejo določitve testa), v manjkajočih časovnih točkah HIV-RNA vrednost izpuščene meritve nad 50 ali nad 400 kopij/ml.
At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Ob izhodišču so imeli mediano plazemsko HIV-1 RNA 4,8 log10 kopij/ml, mediana števila celic CD4+ je znašala 367 celic/mm3 in mediana odstotka CD4+ je znašala 18 %.
Recommendation concerning co-administration with efavirenz immunosuppressants are not anticipated to affect exposure of efavirenz.
Pri teh imunosupresivih ne pričakujemo, da vplivajo na izpostavitev efavirenzu.
Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with nelfinavir and an NRTI in antiretroviral-naive and NRTI-experienced paediatric patients.
Študija PACTG 382 je bila odprta študija za oceno farmakokinetike, varnosti, prenašanja in protivirusnega delovanja efavirenza v kombinaciji z nelfinavirjem in nukleozidnim zaviralcem reverzne transkriptaze (NRTI) pri pediatričnih bolnikih, ki se še niso zdravili s protiretrovirusnimi zdravili, vendar so se že zdravili z NRTI.
Clarithromycin/efavirenz (500 mg q12h/400 mg once daily)
klaritromicin/efavirenz (500 mg q12h/400 mg enkrat na dan)
Cmax: ↑ 11% (↑ 6 to ↑ 16)
Cmax: ↑ 11 % (↑ 6 do ↑ 16) Cmin: ↔
Multipack (carton) containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet) in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Škatla z 90 filmsko obloženimi tabletami (3 škatle po 30x1 filmsko obloženo tableto v belem, prozornem PVC/PVdC-aluminij ali aluminij-aluminij perforiranem enodomernem pretisnem omotu).
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Efavirenz Teva.
Če jemljete katero od naštetih zdravil, vam bo zdravnik morda preveril količino zdravila proti krčem v krvi.
Indinavir/efavirenz (800 mg q8h/200 mg once daily)
indinavir/efavirenz (800 mg q8h/200 mg enkrat na dan)
Clinical efficacy
Učinkovine po terapevtskih področjih
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
AUC: ↓ 60 % (↓ 52 do ↓ 68) Cmax: ↓ 62 % (↓ 55 do ↓ 78)
If you stop taking Efavirenz Teva When your Efavirenz Teva supply starts to run low, get more from your doctor or pharmacist.
Ko gre vaša zaloga zdravila Efavirenz Teva h koncu, si ga priskrbite pri zdravniku oz. farmacevtu.
Hepatitis C antivirals Boceprevir/efavirenz (800 mg 3 times daily/600 mg
Zdravila za zdravljenje hepatitisa C boceprevir/efavirenz (800 mg 3-krat na dan/600 mg enkrat na dan)
- You must remain under the care of your doctor while taking Efavirenz Teva.
- Med jemanjem zdravila Efavirenz Teva morate ostati pod nadzorom zdravnika.
AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58)
AUC: ↓ 39 % (↓ 21 do ↓ 53) Cmax: ↓ 37 % (↓ 20 do ↓ 51) Cmin: ↓ 44 % (↓ 27 do ↓ 58)
Norepinephrine and dopamine reuptake inhibitor Bupropion/efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Zaviralec ponovnega privzema noradrenalina in dopamina bupropion/efavirenz [150 mg enkratni odmerek
The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Za ublažitev odtegnitvenih simptomov so povečali odmerek metadona v povprečju za
In a single-dose study, half-life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
Okvara jeter V študiji z enkratnim odmerjanjem je bil pri edinem bolniku s hudo jetrno okvaro (razred C po Child
CCR5 antagonist Maraviroc/efavirenz (100 mg twice daily/600 mg once daily)
CCR5 antagonisti maravirok/efavirenz (100 mg dvakrat na dan/600 mg enkrat na dan)
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
↔efavirenz
zaradi efavirenza.
Using an ITT analysis, the overall proportion of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (58/102) and 43% (44/102), respectively.
V 48. tednu - pri uporabi analize ITT - je bil celotni delež bolnikov s HIV RNA < 400 kopij/ml 57 % (58/102) in celotni delež bolnikov s HIV RNA < 50 kopij/ml 43 %
Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
atazanavir/ritonavir/efavirenz (400 mg enkrat na dan/200 mg enkrat na dan/600 mg enkrat na dan, vse s hrano)
How to store Efavirenz Teva
Shranjevanje zdravila Efavirenz Teva
artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in your blood atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.
artemeter/lumefantrin: zdravilo Efavirenz Teva lahko zmanjša količino artemetra/lumefantrina v krvi.
Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
simeprevir/efavirenz (150 mg enkrat na dan/600 mg enkrat na dan)
Saquinavir/ritonavir/efavirenz
sakvinavir/ritonavir/efavirenz
Concomitant administration of velpatasvir/sofosbuvir/voxilaprevir with efavirenz is not recommended (see section 4.5).
Sočasne uporabe efavirenza in velpatasvira/sofosbuvira/voksilaprevira ne priporočamo (glejte poglavje 4.5).
AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
AUC: ↓ 64 % (↓ 62 do ↓ 67) Cmax: ↓ 46 % (↓ 39 do ↓ 52) Cmin: ↓ 82 % (↓ 79 do ↓ 85)
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
B ali C, prosimo, preberite tudi ustrezne povzetke glavnih značilnosti teh zdravil.
CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/efavirenz (240 mg once daily/600 mg once daily)
Zaviralci kalcijevih kanalčkov diltiazem/efavirenz (240 mg enkrat na dan/600 mg enkrat na dan)
Seizures
ZDRVILA
Fluoxetine/efavirenz
fluoksetin/efavirenz
ANTIHISTAMINES Cetirizine/efavirenz (10 mg single dose/600 mg once daily)
ANTIHISTAMINIKI cetirizin/efavirenz (enkratni odmerek 10 mg/600 mg enkrat na dan)
ANTICONVULSANTS Carbamazepine/efavirenz (400 mg once daily/600 mg once daily)
ANTIKONVULZIVI karbamazepin/efavirenz (400 mg enkrat na dan/600 mg enkrat na dan)
AUC: ↓ 27% (↓ 20 to ↓ 33) Cmax: ↓ 20% (↓ 15 to ↓ 24) Cmin: ↓ 35% (↓ 24 to ↓ 44)
AUC: ↓ 27 % (↓ 20 do ↓ 33) Cmax: ↓ 20 % (↓ 15 do ↓ 24) Cmin: ↓ 35 % (↓ 24 do ↓ 44)
AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
AUC: ↓ 75 % (↓ 59 do ↓ 84) Cmax: ↓ 64 % (↓ 57 do ↓ 69) Cmin: ↓ 62 % (↓ 44 do ↓ 75)
The median increase from baseline in CD4+ count at 48 weeks of therapy was 128 cells/mm3 and the median increase in CD4+ percentage was 5%.
V 48. tednu mediana povečanja od izhodišča za število celic CD4+ je bila 128 celic/mm3 in mediana povečanja odstotka celic CD4+ je bila 5 %.
Mean change from baseline-CD4 cell count Cells/mm3 (S.E.M.
celic/mm3 (S.N.P.
Lopinavir/ritonavir tablets/ efavirenz
lopinavir/ritonavir mehke kapsule ali peroralna raztopina/efavirenz lopinavir/ritonavir tablete/efavirenz
Triacetin 3
Preglednica 3.
The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in CD4+ percentage was 13%.
V 48. tednu mediana povečanja od izhodišča v številu celic CD4+ je bila 238 celic/mm3 in mediana povečanja odstotka celic CD4+ je bila 13 %.
AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
AUC: ↓ 26 % (↓ 15 do ↓ 36) Cmax: ↓ 20 % (↓ 11 do ↓ 28) Cmin: ↓ 32 % (↓ 15 do ↓ 46)
Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
rifampicin/efavirenz (600 mg enkrat na dan/600 mg enkrat na dan)
Integrase strand transfer inhibitor Raltegravir/efavirenz (400 mg single dose/ -)
raltegravir/efavirenz (400 mg enkratni odmerek/ - )
Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
in je zato pri substratih CYP3A4 z ozkim terapevtskim oknom potrebna previdnost (glejte poglavje 4.3).
Recommendation concerning co-administration with efavirenz efavirenz for any of these medicinal products.
Priporočilo glede sočasne uporabe z efavirenzem odmerjanja.
PARTICULARS TO APPEAR ON THE OUTER CARTON COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS)WITHOUT BLUE BOX
PODATKI NA ZUNANJI OVOJNINI DRUGIH PAKIRANJ SESTAVNI DEL ŠKATLE 90 (3 zloženke po 30x1 filmsko obloženih tablet) - brez »BLUE BOX«
Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
občasni čustvena labilnost, nasilno vedenje, zmedenost, evforično razpoloženje,
Package leaflet: information for the user Efavirenz Teva 600 mg film-coated tablets efavirenz
NAVODILO ZA UPORABO Efavirenz Teva 600 mg filmsko obložene tablete efavirenz
ACID-REDUCING AGENTS Aluminium hydroxidemagnesium hydroxidesimethicone antacid/efavirenz (30 ml single dose/400 mg single dose)
ZDRAVILA ZA KISLINSKO POGOJENE BOLEZNI aluminijev hidroksidnimagnezijev hidroksidnisimetikonijev antacid/efavirenz (enkratni odmerek 30 ml /enkratni odmerek 400 mg)
N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
AUC: ↓ 37 % (↓ 17 do ↓ 52) Cmax: ↓ 28 % (↓ 7 do ↓ 44) Cmin: ↓ 37 % (↓ 17 do ↓ 52)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX
PODATKI NA ZUNANJI OVOJNINI DRUGIH PAKIRANJ ZUNANJA NALEPKA ŠKATLE 90 (3 zloženke po 30x1 filmsko obloženih tablet) - z »BLUE BOX«
Itraconazole/efavirenz (200 mg q12h/600 mg once daily)
Antimikotiki itrakonazol/efavirenz (200 mg q12h/600 mg enkrat na dan)
Efavirenz Teva can reduce the amount of statins in your blood.
Zdravilo Efavirenz Teva lahko zmanjša količino statinov v krvi.
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
AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
AUC: ↓ 18 % (↓ 8 do ↓ 27) Cmax: ↓ 14 % (↓ 3 do ↓ 24) Cmin: ↓ 25 % (↓ 14 do ↓ 34)%
Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
fosamprenavir/ritonavir/ efavirenz (700 mg dvakrat na dan/100 mg dvakrat na dan/600 mg enkrat na dan)
Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Jemanje efavirenza je treba prekiniti pri bolnikih, pri katerih se razvije hud izpuščaj, ki ga spremljajo mehurji,
In 35 patients receiving efavirenz 600 mg once daily, steady-state Cmax was 12.9 ± 3.7 microM (29%) [mean ± S.D. (% C.V.)], steady-state Cmin was 5.6 ± 3.2 microM (57%), and AUC was 184 ± 73 microM·h (40%).
)], Cmin 5,6 ± 3,2 µM (57 %) in AUC 184 ± 73 µM·h (40 %).
Atovaquone and proguanil hydrochloride/efavirenz (250/100 mg single dose/600 mg once daily)
atovakon in progvanilijev klorid/efavirenz (250/100 mg enkratni odmerek/600 mg enkrat na dan)
Cmin: ↓ 44% Efavirenz:
Cmin: ↓ 91 % (↓ 88 do ↓ 92) efavirenz:
Film-coating
filmsko obložena tableta
Implant: Etonogestrel/efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Lahko pričakujemo zmanjšano izpostavitev etonogestrelu (indukcija CYP3A4).
The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Pri jemanju z efavirenzom 600 mg enkrat na dan je treba odmerek lopinavir/ritonavir tablet povečati na 500/125 mg dvakrat na dan. Glejte tudi informacije za ritonavir v nadaljevanju.
Skin rash was considered treatment-related in 18% of patients treated with efavirenz.
Pri 18 % bolnikov, zdravljenih z efavirenzem, so menili, da je pojav izpuščaja povezan z zdravljenjem.
(CYP3A induction by efavirenz)
(indukcija CYP3A z efavirenzem)
Simvastatin/efavirenz (40 mg once daily/600 mg once daily)
simvastatin/efavirenz (40 mg enkrat na dan/600 mg enkrat na dan)
problems with coordination or balance - stomach pain, diarrhoea, feeling sick (nausea), vomiting - itching - tiredness - feeling anxious, feeling depressed
- bolečine v trebuhu, driska, slabost (siljenje na bruhanje), bruhanje
Ritonavir/efavirenz (500 mg twice daily/600 mg once daily)
ritonavir/efavirenz (500 mg dvakrat na dan/600 mg enkrat na dan)
Valproic acid/efavirenz (250 mg twice daily/600 mg once daily)
valprojska kislina/efavirenz (250 mg dvakrat na dan/600 mg enkrat na dan)
In vitro efavirenz is also an inhibitor of CYP3A4.
Efavirenz je tudi inhibitor CYP3A4 in vitro, zato lahko teoretično v osnovi poveča izpostavljenost substratom CYP3A4
Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
flukonazol/efavirenz (200 mg enkrat na dan/400 mg enkrat na dan)
Indinavir/ritonavir/efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
indinavir/ritonavir/efavirenz (800 mg dvakrat na dan/100 mg dvakrat na dan/600 mg enkrat na dan)
Atovaquone:
atovakon:
Medicines used to treat depression such as imipramine, amitriptyline or clomipramine Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
- zdravila za zdravljenje depresije kot so imipramin, amitriptilin ali klomipramin.
Effects on drug levels Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea
Srednja sprememba AUC, Cmax,
Voriconazole/efavirenz (400 mg twice daily/300 mg once daily)
vorikonazol/efavirenz (400 mg dvakrat na dan/300 mg enkrat na dan)
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).
lahko po potrebi povečate odmerek zdravila Efavirenz na 800 mg/dan (glejte poglavje 4.5).
Stevens-Johnson syndrome) - yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver - breast enlargement in males - angry behaviour, mood being affected, seeing or hearing things that are not really there
- porumenelost kože ali oči, srbenje ali bolečina v trebuhu (želodcu) zaradi vnetja jeter - povečanje prsi pri moških
Symptoms including, but not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
V kliničnih študijah pri bolnikih, ki so jemali 600 mg efavirenza na dan, so pogosto poročali o neželenih učinkih, ki so vključevali tudi naslednje simptome: omotico, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje (glejte poglavje 4.8).
b C.I., confidence interval.
Cmin z intervali zaupanja, če so na voljo a
There have also been post-marketing reports of death by suicide, delusions, psychosis-like behaviour and catatonia.
V obdobju trženja zdravila so poročali tudi o smrti zaradi samomora, blodnjavih motnjah,
(induction of metabolism)
(indukcija presnove)
AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
AUC: ↑ 11 % (↑ 5 do ↑ 18) Cmax: ↑ 16 % (↑ 6 do ↑ 26) Cmin: ↑ 13 % (↑ 1 do ↑ 26)
< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); or very rare (< 1/10,000).
ali zelo redki (< 1/10.000).
Plasma trough concentrations of boceprevir were decreased when
Najnižje plazemske koncentracije boceprevirja pred naslednjim odmerkom so se pri sočasni uporabi z efavirenzem zmanjšale.
- Efavirenz Teva must be taken every day.
- Zdravilo Efavirenz Teva se vzame skozi usta.
Reproductive system and breast disorders Uncommon Gynaecomastia
redki fotoalergijski dermatitis† Motnje reprodukcije in dojk občasni ginekomastija
Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Koncentracije lopinavirja: podobne kot pri lopinavirju/ritonavirju 400/100 mg dvakrat na dan brez efavirenza nelfinavir/efavirenz (750 mg q8h/600 mg enkrat na dan)
Pravastatin/efavirenz (40 mg once daily/600 mg once daily)
pravastatin/efavirenz (40 mg enkrat na dan/600 mg enkrat na dan)
EXPIRY DATE
tremor†
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
Other interactions: efavirenz does not bind to cannabinoid receptors.
a 90-odstotni intervali zaupanja, razen če ni drugače navedeno b 95-odstotni intervali zaupanja Druge interakcije: efavirenz se ne veže na kanabinoidne receptorje.
NRTIs
CART.
AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
AUC: ↓ 52 % (↓ 33 do ↓ 66) Cmax: ↓ 45 % (↓ 25 do ↓ 59)
Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks.
Simptomi živčnega sistema se običajno pojavijo kmalu po začetku zdravljenja in običajno minejo po prvih 2 - 4 tednih.
Medicinal product by therapeutic areas (dose)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Voriconazole/efavirenz (200 mg twice daily/400 mg once daily)
vorikonazol/efavirenz (200 mg dvakrat na dan/400 mg enkrat na dan)
CD4+ count at 48 weeks was 215 cells/mm3 and the median increase in CD4+ percentage was 6%.
V 48. tednu mediana povečanja od izhodišča v številu celic CD4+ je znašala 215 celic/mm3 in mediana povečanja odstotka celic CD4+ je znašala
efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
morebitnih farmakodinamičnih interakcij.
Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended, as it may decrease concentrations of velpatasvir and voxilaprevir.
voksilaprevira ni priporočljiva, saj lahko zmanjša koncentracijo velpatasvira in voksilaprevira.
EU/1/11/742/004 (bundle multi-pack - blister PVC/PVDC/alu) EU/1/11/742/009 (bundle multi-pack - blister alu/alu)
EU/1/11/742/004 (omot z 90 filmsko obloženimi tabletami - pretisni omot PVC/PVDC/alu) EU/1/11/742/009 (omot z 90 filmsko obloženimi tabletami - pretisni omot alu/alu)
AUC: ↑ 7% (↑ 1 to ↑ 14) Cmax: ↑ 16% (↑ 2 to ↑ 32) These changes are not considered clinically significant.
AUC: ↑ 7 % (↑ 1 do ↑ 14) Cmax: ↑ 16 % (↑ 2 do ↑ 32)
EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
EU/1/11/742/005 (omot z 90 filmsko obloženimi tabletami - pretisni omot PVC/PVDC/alu) EU/1/11/742/010 (omot z 90 filmsko obloženimi tabletami - pretisni omot alu/alu)
AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
AUC: ↓ 18 % (↓ 10 do ↓ 26) Cmax: ↓ 24 % (↓ 15 do ↓ 32) Cmin: ↓ 10 % (↑ 1 do ↓ 19)%
Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Antibiotiki azitromicin/efavirenz (enkratni odmerek 600 mg/ 400 mg enkrat na dan)
Name and address of the manufacturer responsible for batch release PLIVA Hrvatska d.o.o.
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Efavirenz Teva may reduce the amount of posaconazole in your blood.
Zdravilo Efavirenz Teva lahko zmanjša količino posakonazola v krvi.
Antimycobacterials Rifabutin/efavirenz (300 mg once daily/600 mg once daily)
Zdravila za zdravljenje okužb z mikobakterijami rifabutin/efavirenz (300 mg enkrat na dan/600 mg enkrat na dan)
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i.e. to 300 mg once daily.
400 mg dvakrat na dan, odmerek efavirenza pa zmanjšati za 50 %, to je na 300 mg enkrat na dan.
30 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Perforirani, bel, prozoren PVC/PVdC-aluminij ali aluminij-aluminij, enoodmerni pretisni omot, ki vsebuje 30x1 filmsko obloženo tableto.
Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Zdravila za zdravljenje okužbe s HIV Zaviralci proteaze (ZP) atazanavir/ritonavir/efavirenz (400 mg enkrat na dan/100 mg enkrat na dan/600 mg enkrat na dan, vse s hrano)
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Efavirenz Teva.
Vendar pa v večini primerov izpuščaj izgine, ne da bi spremenili zdravljenje z zdravilom Efavirenz Teva.
Uncommon Tinnitus†, vertigo Vascular disorders
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus†, vertigo
Famotidine/efavirenz (40 mg single dose/400 mg single dose)
famotidin/efavirenz (enkratni odmerek 40 mg /enkratni odmerek 400 mg) ANKSIOLITIKI lorazepam/efavirenz (enkratni odmerek 2 mg/600 mg enkrat na dan)
Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient
Sočasni uporabi posakonazola in efavirenza se je treba izogibati,
HIV antivirals Protease inhibitors (PI)
Zaviralec integraze (prepreči vgradnjo virusne DNA v celično DNA)
In Europe, nimesulide is nationally authorised in 16 Member States (Austria, Belgium, Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Slovakia and Slovenia).
V Evropi so nimesulid odobrili pristojni nacionalni organi v 17 državah članicah (Avstriji, Belgiji, Bolgariji, Češki republiki, Cipru, Franciji, Grčiji, Madžarski, Italiji, Latviji, Litvi, Malti, Poljska, Portugalski, Romuniji, Slovaški in Sloveniji).
The harmonised product information were implemented in the Member States end of 2004-beginning of 2005.
Usklajene informacije o zdravilu so bile v državah članicah uveljavljene v obdobju od konca leta 2004 do začetka leta 2005.
Nimesulide-containing medicinal products are currently marketed in more than 50 countries worldwide, particularly in Europe and South America.
Zdravila, ki vsebujejo nimesulid, se trenutno tržijo v več kot 50 državah po svetu, zlasti pa v Evropi in Južni Ameriki.
Conditions of the Marketing Authorisations are identified in Annex IV of this Opinion.
Pogoji dovoljenja za promet z zdravilom so opredeljeni v Dodatku IV te odločbe.
Having considered all of the available evidence, the CHMP concluded that the data did not support a suspension of all marketing authorisations in Europe.
Ob upoštevanju vseh razpoložljivih dokazov je CHMP zaključil, da podatki ne podpirajo umika vseh dovoljenj za promet v Evropi.
The assessment of these consequences were supported by a simulation of the possible impact of nimesulide withdrawal in Italy.
Oceno teh posledic so podprli s simulacijo potencialnih učinkov umika nimesulida s trga v Italiji.
- The maximum duration of a treatment course with nimesulide is 15 days.
- Najdaljše trajanje zdravljenja z nimesulidom je 15 dni.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS) (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL (ZDRAVIL ZA SISTEMSKO UPORABO), KI VSEBUJEJO NIMESULID (glejte Dodatek I)