FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of efavirenz on male and female fertility in rats has only been evaluated at doses that achieved systemic drug exposures equivalent to or below those achieved in humans given recommended doses of efavirenz.
Slovenian: Učinek efavirenza na plodnost podganjih samcev in samic je bil ovrednoten le pri odmerkih, pri katerih so bile dosežene enake ali manjše sistemske izpostavljenosti učinkovini kot pri ljudeh, ki so jemali priporočene odmerke efavirenza.
English: Common (affects 1 to 10 users in 100) abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance stomach pain, diarrhoea, feeling sick (nausea), vomiting itching tiredness feeling anxious, feeling depressed
Slovenian: Pogosti (pojavijo se pri 1 do 10 od 100 bolnikov) nenormalne sanje, težave s koncentracijo, omotica, glavobol, oteženo spanje, zaspanost, težave s koordinacijo ali z ravnotežjem bolečine v trebuhu, driska, slabost (siljenje na bruhanje), bruhanje srbenje utrujenost občutek tesnobe, depresivno počutje
English: St. John's wort (Hypericum perforatum)
Slovenian: Šentjanževka (Hypericum perforatum)
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Slovenian: Izpuščaji so navadno blagi do zmerni makulopapularni kožni izpuščaji, ki se pojavijo v prvih dveh tednih po začetku zdravljenja z efavirenzem.
English: Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Slovenian: Za odstranitev neabsorbiranega efavirenza lahko uporabimo aktivno oglje.
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Slovenian: Za ublažitev odtegnitvenih simptomov so povečali odmerek metadona v povprečju za 22%.
English: Renal insufficiency
Slovenian: Ledvična insuficienca
English: In clinical controlled trials, frequently reported adverse reactions included, but were not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Slovenian: V nadzorovanih kliničnih preizkušanjih so pogosto poročani neželeni učinki vključevali tudi (vendar ne samo): omotico, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje.
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Slovenian: Induktivni učinek šentjanževke lahko traja vsaj še 2 tedna po prenehanju zdravljenja (glejte poglavje 4.3).
English: Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash.
Slovenian: Uporaba ustreznih antihistaminikov in/ali kortikosteroidov lahko izboljša prenašanje zdravila in pospeši zdravljenje izpuščaja.
English: 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).
Slovenian: 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).
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking SUSTIVA.
Slovenian: Zato morate upoštevati zgoraj opisana navodila glede kontracepcije še 12 tednov po prenehanju zdravljenja z zdravilom SUSTIVA.
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Slovenian: Zdravila za zdravljenje bakterijskih okužb, vključno s tuberkulozo in z AIDS-om povezano okužbo z Mycobacterium avium: klaritromicin, rifabutin, rifampicin.
English: A multipledose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Slovenian: Študija z večkratnim odmerjanjem ni pokazala nobenega pomembnega učinka na farmakokinetiko efavirenza pri bolnikih z blago okvaro jeter (razred A po Child Pugh-u) v primerjavi s kontrolno skupino.
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Slovenian: V teh študijah je bil odmerek efavirenza 600 mg enkrat na dan. Odmerek indinavirja pri uporabi z efavirenzem je bil 1.000 mg na vsakih 8 ur, brez uporabe efavirenza pa 800 mg na vsakih 8 ur.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Slovenian: Efavirenz je treba dajati v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
English: Mean Cmax µg/mL
Slovenian: Srednja vrednost Cmax µg/ml
English: In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose.
Slovenian: V eni študiji so se simptomi, povezani z živčnim sistemom, pogosto pojavili v prvi do prvih treh urah po zaužitju odmerka.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Slovenian: Upoštevati je treba možnost uporabe alternativ klaritromicinu (npr. azitromicina).
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however, inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Slovenian: Efavirenz morda inducira CYP2C19 in CYP2C9, vendar so opazili tudi inhibicijo in vitro, in zato skupni učinek sočasne uporabe s substrati za ta encima ni jasen (glejte poglavje 5.2).
English: Medicines used to treat depression such as imipramine, amitriptyline or clomipramine.
Slovenian: zdravila za zdravljenje depresije kot so imipramin, amitriptilin ali klomipramin.
English: Bupropion (a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
Slovenian: Bupropion (zdravilo za zdravljenje depresije ali za pomoč pri prenehanju kajenja): zdravnik vam bo morda spremenil odmerek bupropiona.
English: Number of Capsules or Tablets and Strength to Administer kg
Slovenian: Število kapsul ali tablet in jakost odmerka
English: In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
Slovenian: V podskupini 1.008 odraslih bolnikov, ki so v nadzorovanih kliničnih študijah prejemali dnevno 600 mg efavirenza v kombinaciji z ZP-ji in/ali NRTI-ji, so bili najpogostejši neželeni učinki, ki so bili vsaj zmerne jakosti in so o njih poročali pri vsaj 5 % bolnikov: izpuščaj (11,6 %), omotica (8,5 %), navzea (8,0 %), glavobol (5,7 %) in utrujenost (5,5 %).
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
Slovenian: O hudem izpuščaju, ki ga spremljajo mehurji, vlažno luščenje kože ali ulceracije, so poročali pri manj kot 1 % bolnikov, zdravljenih z efavirenzem.
English: When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored.
Slovenian: Ko je zdravljenje z vorikonazolom končano, je potrebno ponovno uvesti začetni odmerek efavirenza.
English: If efavirenz and telaprevir are co-administered, telaprevir 1,125 mg every 8 hours should be used.
Slovenian: Pri sočasni uporabi efavirenza in telaprevirja je treba uporabiti telaprevir v odmerku 1,125 mg vsakih 8 ur.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing antiretroviral therapy and subjects receiving no antiretroviral therapy.
Slovenian: V 3-mesečni študiji interakcij med učinkovinami niso ugotovili pomembnih razlik v farmakokinetičnih parametrih medroksiprogesteronacetata (MPA) med osebami, ki so bile na protiretrovirusnem zdravljenju, ki je vključevalo efavirenz, in osebami brez protiretrovirusnega zdravljenja.
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Slovenian: Malo podatkov kaže na to, da ni klinično pomembnega učinka na farmakokinetiko valprojske kisline.
English: 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.
Slovenian: Pri analizi deležev bolnikov, ki so se odzvali na zdravljenje (bolnik, ki raziskave ni končal, pomeni napako analize; NK = NA), so privzeli, da imajo bolniki, ki so študijo iz kakršnega koli razloga predčasno prekinili ali so izpustili eno merjenje HIV-RNA vrednosti (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.
English: Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTIexperienced HIV-infected patients.
Slovenian: Dve nadzorovani študiji (006 in ACTG 364) z efavirenzem v kombinaciji z NRTI-ji in/ali zaviralci proteaze, ki sta trajali približno eno leto, sta pokazali zmanjšanje virusnega bremena pod mejo določitve testa in povečanje števila CD4 limfocitov pri s HIV okuženih bolnikih, ki še niso dobivali protiretrovirusnih zdravil in tistih, ki so že bili zdravljeni z NRTI-ji.
English: Clinically significant interactions are not expected since vigabatrin and gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Slovenian: Klinično pomembnih interakcij ni pričakovati, saj se vigabatrin in gabapentin izločata izključno z urinom v nespremenjeni obliki ter ni verjetno, da bi prišlo do kompeticije za iste presnovne encime in poti izločanja kot pri efavirenzu.
English: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms.
Slovenian: Najopaznejši neželeni učinki, povezani z efavirenzem, so izpuščaj in simptomi živčnega sistema.
English: An empty stomach is commonly defined as 1 hour before or 2 hours after a meal.
Slovenian: Na tešče običajno pomeni 1 uro pred ali 2 uri po obroku.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Slovenian: Pokazalo se je, da efavirenz inducira CYP3A4 in CYP2B6, s čimer povzroči indukcijo svoje lastne presnove, kar je lahko pri nekaterih bolnikih klinično pomembno.
English: The net effect of coadministration is not clear.
Slovenian: Skupni učinek sočasne uporabe ni jasen.
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Slovenian: Ker se rosuvastatin v veliki meri izloči nespremenjen z blatom, ne pričakujemo interakcij z efavirenzem.
English: Table 4: Efficacy results for studies ACTG 364 and 020
Slovenian: Preglednica 4: Rezultati učinkovitosti za študiji ACTG 364 in 020
English: If you forget to take SUSTIVA
Slovenian: Če ste pozabili vzeti zdravilo SUSTIVA
English: SUSTIVA, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Slovenian: Zdravilo SUSTIVA, ki vsebuje učinkovino efavirenz, spada v razred protiretrovirusnih zdravil, imenovanih nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
English: Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Slovenian: V študiji 020 je sodelovalo 327 bolnikov, zdravljenih z NRTI, ne pa z ZP ali NNRTI.
English: Dose adjustment of warfarin or acenocoumarol may be required.
Slovenian: Morda bo potrebno prilagoditi odmerek varfarina ali acenokumarola.
English: Clinically significant interactions are not expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Slovenian: Klinično pomembnih interakcij ni pričakovati, saj se zdravila NRTI presnavljajo po drugi poti kot efavirenz in ni verjetno, da bi prišlo do kompeticije za iste presnovne encime in poti izločanja.
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Slovenian: Ker ima fluoksetin podoben presnovni profil kot paroksetin, tj. močno zavira CYP2D6, tudi pri fluoksetinu ni pričakovati interakcij.
English: 3, or after failure of protease inhibitor (PI) containing regimens.
Slovenian: 3, ali po neuspelem zdravljenju z režimom, ki je vključeval zaviralce proteaze (ZP).
English: Coadministration of higher doses of either efavirenz or carbamazepine has not been studied.
Slovenian: Sočasne uporabe večjih odmerkov obeh, efavirenza ali karbamazepina, niso preučevali.
English: ↓glecaprevir ↓ pibrentasvir
Slovenian: ↓glekaprevir ↓pibrentasvir
English: The most notable unwanted effects reported with SUSTIVA in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
Slovenian: Najbolj opazni neželeni učinki, o katerih so poročali pri zdravilu SUSTIVA v kombinaciji z drugimi zdravili proti HIV, so kožni izpuščaji in simptomi, povezani z boleznimi živčevja.
English: The child should not be given any additional food for 2 hours.
Slovenian: Otroka ne hranite nadaljnji 2 uri.
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil.
Slovenian: Specifičnih študij interakcij z efavirenzem in zdravili NRTI, razen z lamivudinom, zidovudinom in dizoproksiltenofovirat, niso opravili.
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with SUSTIVA.
Slovenian: Zdravnik vam bo morda naročil, da pred začetkom zdravljenja z zdravilom SUSTIVA, opravite test nosečnosti, da se prepriča, da niste noseči.
English: Cross resistance
Slovenian: Navzkrižna rezistenca
English: Mean Cmin µg/mL
Slovenian: Srednja vrednost Cmin µg/ml
English: It is recommended to hold the capsule with the cap facing up and to pull the cap away from the body of the capsule, and to mix the capsule contents with food in a small container.
Slovenian: Kapsulo je priporočeno držati tako, da je pokrovček na vrhu, in povleči pokrovček od jedra kapsule, nato pa zmešati njeno vsebino s hrano v manjši posodi.
English: Concomitant administration of efavirenz with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir.
Slovenian: Sočasna uporaba efavirenza in elbasvira/grazoprevira je kontraindicirana, saj lahko povzroči izgubo virološkega odziva na elbasvir/grazoprevir.
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Slovenian: Je protiretrovirusno zdravilo, ki zmanjšuje količino virusa v krvi in se tako bori proti okužbi z virusom humane imunske pomanjkljivosti (HIV-1).
English: When using efavirenz with lowdose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Slovenian: Pri uporabi efavirenza z majhnim odmerkom ritonavirja, je treba upoštevati možnost povečanja pogostnosti neželenih učinkov, povezanih z efavirenzem, zaradi morebitnih farmakodinamičnih interakcij.
English: cells/mm3 (S.E.M.d)
Slovenian: celic/mm3 (S.N.P.d)
English: Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking another NNRTI.
Slovenian: Efavirenza ne priporočamo bolnikom, ki so imeli med jemanjem drugega NNRTI-ja življenje ogrožajočo reakcijo na koži (npr. StevensJohnsonov sindrom).
English: Efavirenz intact hard capsules must only be administered to children who are able to reliably swallow hard capsules.
Slovenian: Cele trde kapsule efavirenza smemo dati samo otrokom, ki so zagotovo zmožni pogoltniti trde kapsule.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of
Slovenian: Brez vpliva (↔) ustreza zmanjšanju povprečnega odstotka za ≤ 20 % ali zvečanju povprečnega odstotka za ≤ 25 %
English: When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Slovenian: Pri sočasni uporabi efavirenza in zaviralca kalcijevih kanalčkov, ki je substrat za encim CYP3A4, obstaja možnost za zmanjšanje plazemskih koncentracij zaviralca kalcijevih kanalčkov.
English: Two of three delavirdineresistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Slovenian: Dva od treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
English: The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
Slovenian: Varnost in učinkovitost efavirenza pri bolnikih z obstoječimi pomembnimi boleznimi jeter nista bili dokazani.
English: The mechanism of the effect on velpatasvir is induction of CYP3A and CYP2B6 by efavirenz.
Slovenian: Mehanizem učinka na velpatasvir je indukcija CYP3A in CYP2B6 zaradi efavirenza.
English: Tests may show: increased liver enzymes in the blood increased trigycerides (fatty acids) in the blood
Slovenian: Testi lahko pokažejo: povišane vrednosti jetrnih encimov v krvi povišane vrednosti trigliceridov (maščobnih kislin) v krvi
English: If you see any signs of a severe rash with blistering or fever, stop taking SUSTIVA and tell your doctor at once.
Slovenian: Če opazite kateri koli znak hudega izpuščaja z mehurji ali zvišano telesno temperaturo, prenehajte jemati zdravilo SUSTIVA in se takoj posvetujte z zdravnikom.
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
Slovenian: Zdravila za zdravljenje okužbe z virusom hepatitisa C: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voksilaprevir, glekaprevir/pibrentasvir.
English: Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti zvišana aspartat-aminotransferaza (AST)*, zvišana alanin-aminotransferaza (ALT)*, zvišana gama-glutamiltransferaza (GGT)*
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30 x 1) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Multipakiranje: 90 (3 pakiranja po 30 x 1) filmsko obloženih tablet
English: Liver enzymes: elevations of AST and ALT to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5-8% after longterm treatment in study 006).
Slovenian: Jetrni encimi: povišanje AST in ALT na več kot petkratno zgornjo mejo normalnih vrednosti (ZMN) so opazili pri 3 % od 1.008 bolnikov, zdravljenih s 600 mg efavirenza (5-8 % po dolgotrajnem zdravljenju v študiji 006).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION SUSTIVA 50 mg hard capsules
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA SUSTIVA 50 mg trde kapsule
English: Rash was more common in children than in adults treated with SUSTIVA.
Slovenian: Izpuščaj se je pojavljal bolj pogosto pri otrocih kakor pri odraslih, zdravljenih z zdravilom SUSTIVA.
English: - a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Slovenian: - anamnezo simptomatskih srčnih aritmij ali s klinično pomembno bradikardijo ali s kongestivnim srčnim popuščanjem skupaj z zmanjšanim iztisnim deležem levega prekata.
English: If you could get pregnant while receiving SUSTIVA, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Slovenian: Če med jemanjem zdravila SUSTIVA obstaja možnost zanositve, morate uporabljati zanesljivo mehansko kontracepcijo (na primer kondom) skupaj z drugimi metodami kontracepcije, vključno s peroralno kontracepcijo (tableto) ali drugimi hormonskimi kontraceptivi (na primer vsadki, injekcijo).
English: a 90% confidence intervals unless otherwise noted.
Slovenian: a 90-odstotni intervali zaupanja, razen če ni drugače navedeno b 95-odstotni intervali zaupanja
English: Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5).
Slovenian: Vedno je treba uporabljati mehansko metodo kontracepcije skupaj s še drugimi metodami kontracepcije (na primer peroralne ali druge hormonske kontraceptive, glejte poglavje 4.5).
English: common pruritus uncommon erythema multiforme, Stevens-Johnson syndrome*
Slovenian: pogosti srbenje občasni multiformni eritem, Stevens-Johnsonov sindrom*
English: Laboratory test abnormalities
Slovenian: Nenormalne vrednosti laboratorijskih testov
English: 25 to < 32.5
Slovenian: 25 do < 32,5
English: If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
Slovenian: Če potrebujete pomoč pri načrtovanju najboljšega urnika jemanja zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Dose adjustments of the immunosuppressant may be required.
Slovenian: Morda bo potrebno prilagoditi odmerek imunosupresiva.
English: Capsule sprinkle: for patients at least 3 months old and weighing at least 3.5 kg who cannot swallow capsules, the capsule contents can be administered with a small amount of food using the capsule sprinkle method of administration (see section 6.6 for instructions).
Slovenian: Posutje kapsule: bolnikom, ki so stari vsaj 3 mesece, tehtajo vsaj 3,5 kg in ne morejo pogoltniti kapsul, se lahko vsebina kapsule da z majhno količino hrane z uporabo metode posutja kapsule (navodila so v poglavju 6.6).
English: Artemether:
Slovenian: artemeter: