FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
Slovenian: Pri bolnikih z obstoječimi motnjami prevajanja (atrioventrikularni blok druge ali višje stopnje ali kompleksni kračni blok) je treba zdravilo REYATAZ uporabljati previdno in le, če korist odtehta tveganje (glejte poglavje 5.1).
English: REYATAZ 300 mg hard capsules Capsule contents: crospovidone, lactose monohydrate and magnesium stearate
Slovenian: REYATAZ 300 mg trde kapsule Vsebina kapsul: krospovidon, laktoza monohidrat in magnezijev stearat.
English: REYATAZ given without ritonavir should not be considered in patients treated with a backbone regimen containing tenofovir disoproxil and with other concomitant medications that reduce atazanavir bioavailability (see section 4.5 In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen) or in case of perceived challenging compliance.
Slovenian: Zdravila REYATAZ brez ritonavirja se ne sme uporabljati pri bolnikih, ki se zdravijo z osnovnim režimom, ki vsebuje dizoproksiltenofovirat, in z drugimi sočasno uporabljenimi zdravili, ki zmanjšujejo biološko uporabnost atazanavirja (glejte poglavje 4.5 V primeru odtegnitve ritonavirja iz priporočenega režima zdravljenja z okrepitvijo farmakokinetike atazanavirja) ali v primeru pričakovanih težav s sodelovanjem bolnika pri zdravljenju.
English: The mean AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Slovenian: Pri osebah z okvaro delovanja jeter je bila srednja vrednost AUC(0-∞) za 42% večja kot pri zdravih osebah.
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and REYATAZ without ritonavir may affect atazanavir concentrations co-administration of fluticasone and REYATAZ without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with REYATAZ without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Slovenian: Posamezen odmerek famotidina ne sme preseči 20 mg, skupni dnevni odmerek famotidina pa ne sme biti večji od 40 mg. upoštevati je treba pri sočasni uporabi vorikonazola in zdravila REYATAZ brez ritonavirja se lahko pojavi vpliv na koncentracije atazanavirja pri sočasni uporabi flutikazona in zdravila REYATAZ brez ritonavirja se lahko povečajo koncentracije flutikazona v primerjavi z uporabo flutikazona samega če bolnica uporablja peroralni kontraceptiv skupaj z zdravilom REYATAZ brez ritonavirja, je priporočljivo, da peroralni kontraceptiv ne vsebuje več kot 30 µg etinilestradiola odmerka lamotrigina ni treba prilagajati
English: The dose of REYATAZ oral powder for children is calculated by body weight and is taken once daily with food and ritonavir as shown below:
Slovenian: Odmerek zdravila REYATAZ peroralni prašek za otroke se izračuna na osnovi telesne mase in se ga jemlje enkrat na dan skupaj s hrano in z ritonavirjem, kot je prikazano v spodnji preglednici:
English: For young infants (less than 6 months) who cannot eat solid food or drink from a cup, REYATAZ oral powder should be mixed with infant formula and given using an oral syringe, which can be obtained from a pharmacist.
Slovenian: Manjšim dojenčkom (mlajšim od 6 mesecev), ki ne morejo uživati goste hrane ali piti iz kozarca, je treba zdravilo REYATAZ peroralni prašek zmešati z začetno formulo za dojenčke in dati s pomočjo brizge za peroralno dajanje, ki se jo lahko dobi pri farmacevtu.
English: d Ritonavir oral solution or capsule/tablet.
Slovenian: d Ritonavir v obliki peroralne raztopine ali kapsule/tablete.
English: Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Slovenian: Na račun nespremenjenega zdravila je šlo v blatu približno 20%, v urinu pa 7% apliciranega odmerka.
English: 100 mg a Ritonavir capsules, tablets or oral solution.
Slovenian: 100 mg a Ritonavir v obliki kapsul, tablet ali peroralne raztopine.
English: When REYATAZ/ritonavir is co-administered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Slovenian: Če se zdravilo REYATAZ/ritonavir uporablja sočasno bodisi s fenitoinom bodisi s fenobarbitalom, bo odmerek fenitoina ali fenobarbitala morda treba prilagoditi.
English: Your doctor should do blood tests prior you start REYATAZ and during treatment.
Slovenian: Zdravnik mora pred začetkom zdravljenja z zdravilom REYATAZ in med zdravljenjem opravljati krvne preiskave.
English: A: To mix the recommended number of REYATAZ oral powder sachets with liquid infant formula in a small medicine cup or small container and to administer with an oral syringe, which can be obtained from a pharmacist: A spoon is used to mix the content of the appropriate number of sachets (4 or 5 sachets depending on infant weight) with 10 ml of prepared liquid infant formula in the medicine cup or small container.
Slovenian: A: Priprava mešanice priporočenega števila vrečic zdravila REYATAZ peroralni prašek z začetno tekočo formulo za dojenčke v merici za odmerjanje zdravil ali manjši posodici in dajanje s pomočjo brizge za peroralno dajanje, ki jo lahko dobite pri farmacevtu: V merici za odmerjanje zdravil ali manjši posodici z žlico zmešajte vsebino ustreznega števila vrečic (4 ali 5 vrečic glede na telesno maso dojenčka) z 10 ml pripravljene začetne tekoče formule za dojenčke.
English: Interactions between atazanavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Slovenian: V spodnji preglednici so navedene interakcije med atazanavirjem/ritonavirjem in zaviralci proteaz, drugimi protiretrovirusnimi zdravili ter drugimi neprotiretrovirusnimi zdravili (zvišanje je navedeno kot “↑”, znižanje kot “↓”, brez spremembe kot “↔”).
English: The use of REYATAZ with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Med nosečnostjo se sme zdravilo REYATAZ z ritonavirjem uporabljati le, če možne koristi upravičujejo možna tveganja.
English: a Atazanavir peak concentrations and AUCs were found to be approximately 26-40% higher during the postpartum period (4-12 weeks) than those observed historically in HIV infected, non-pregnant patients.
Slovenian: a Najvišje koncentracije atazanavirja in vrednosti AUC so bile po porodu (4-12 tednov) za približno od 26 do 40% višje od vrednosti, predhodno ugotovljenih pri z virusom HIV okuženih bolnicah, ki niso bile noseče.
English: Linearity/non-linearity: the pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV infected patients; significant differences were observed between the two groups.
Slovenian: Linearnost/nelinearnost: farmakokinetiko atazanavirja so ocenili pri zdravih odraslih prostovoljcih in bolnikih, okuženih s HIV.
English: REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Slovenian: Varnost zdravila REYATAZ so ocenili v sklopu kombiniranega zdravljenja z drugimi protiretrovirusnimi zdravili v nadzorovanih kliničnih preskušanjih pri 1.806 odraslih bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 400 mg enkrat na dan (1.151 bolnikov, mediani čas zdravljenja 52 tednov, najdaljši čas zdravljenja 152 tednov) ali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan (655 bolnikov, mediani čas zdravljenja 96 tednov, najdaljši čas zdravljenja 108 tednov).
English: Effect on atazanavir and ritonavir exposure has not been studied.
Slovenian: Vpliva na izpostavljenost atazanavirju in ritonavirju niso raziskovali.
English: Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Slovenian: Pri bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg, je bila pogostnost zlatenice 19%.
English: Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for REYATAZ + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Slovenian: Pri 48-tedenskem zdravljenju so bile srednje spremembe vrednosti HIV RNA od izhodišča pri zdravilu REYATAZ + ritonavir in lopinavir + ritonavir podobne (niso bile slabše).
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Slovenian: Didanozin (pufrane tablete) 200 mg/stavudin 40 mg, oboje v enkratnem odmerku (atazanavir 400 mg enkratni odmerek)
English: It is recommended that the International Normalised Ratio (INR) be monitored carefully during treatment with REYATAZ, especially when commencing therapy.
Slovenian: Med zdravljenjem z zdravilom REYATAZ priporočamo skrben nadzor internacionalnega normaliziranega razmerja (INR), še posebej ob uvedbi zdravljenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION REYATAZ 100 mg hard capsules
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA REYATAZ 100 mg trde kapsule
English: Irinotecan
Slovenian: Irinotekan
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CId] Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml
Slovenian: Povprečna časovna razlika ATV/RTVLPV/RTV [97,5% IZd] 48. teden 96. teden 48. teden 96. teden 48. teden 96. teden Srednja sprememba vrednosti HIV RNA od izhodišča, log10 kopij/ml
English: If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product to your child.
Slovenian: Če vam je zdravnik povedal, da otrok ne prenaša nekaterih sladkorjev, se pred začetkom dajanja tega zdravila otroku posvetujte z zdravnikom.
English: common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Slovenian: pogosti: izpuščaj; občasni: multiformni eritema,b, toksični izbruhi na kožia,b, sindrom medikamentoznega izpuščaja z eozinofilijo in s sistemskimi simptomi (DRESS)a,b, angioedema, urtikarija, alopecija, pruritus; redki: Stevens-Johnsonov sindrom a,b
English: In paediatric patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk.
Slovenian: Pri pediatričnih bolnikih s predhodno prisotnimi težavami v prevajanju (atrioventrikularni blok druge ali višje stopnje ali kompleksni kračni blok) je treba zdravilo REYATAZ uporabljati previdno in samo v primerih, kjer so koristi za bolnika večje od tveganja.
English: De novo substitutions in treatment naive patients failing therapy with atazanavir + ritonavir (Study 138, 96 weeks)
Slovenian: Preglednica 3: Pojav novih substitucij pri predhodno še nezdravljenih bolnikih po neuspešnem zdravljenju z atazanavirjem + ritonavirjem (Študija 138, 96 tednov) Pogostnost
English: Co-administration warrants clinical monitoring for sedation and cognitive effects.
Slovenian: Pri sočasni uporabi je potreben klinični nadzor sedacije in učinkov na kognitivno funkcijo.
English: a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Slovenian: a Število bolnikov s pari genotipov, označenimi kot virusni neodziv (HIV RNA ≥ 400 kopij/ml).
English: uncommon: hypersensitivity
Slovenian: občasni: preobčutljivost
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
Slovenian: * V kombinirani analizi so atazanavir 300 mg in ritonavir 100 mg (n=33) primerjali z atazanavirjem 400 mg brez ritonavirja (n=28).
English: For children who are able to drink from a cup, REYATAZ oral powder must be taken with food or drinks.
Slovenian: Otroci, ki lahko pijejo iz kozarca, morajo zdravilo REYATAZ peroralni prašek vzeti skupaj s hrano ali napitkom.
English: Itraconazole
Slovenian: Itrakonazol
English: Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% The mechanism is UGT1A1 inhibition.
Slovenian: Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12ur ↑77% Mehanizem je zaviranje UGT1A1.
English: Put the syringe tip into the mixture and pull back the plunger until the full amount of infant formula is taken up.
Slovenian: Konico brizge namestite v mešanico in bat vlecite nazaj, dokler v brizgo ne izvlečete celotno količino začetne formule za dojenčke.
English: REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Slovenian: Zdravilo REYATAZ kapsule je ob sočasni uporabi majhnih odmerkov ritonavirja indicirano za zdravljenje s HIV-1 okuženih odraslih in pediatričnih bolnikov, starih 6 let ali več, v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.2).
English: The mechanism of interaction between REYATAZ/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Slovenian: Mehanizem interakcije med zdravilom REYATAZ/ritonavirjem in sofosbuvirjem/velpatasvirjem/voksilaprevirjem je zaviranje OATP1B, Pgp in CYP3A.
English: Preparing and giving the medicine with liquid infant formula using a medicine cup or small container and oral syringe (ask your pharmacist for an oral syringe):
Slovenian: Priprava in dajanje zdravila z začetno tekočo formulo za dojenčke z uporabo merice za odmerjanje zdravil ali manjše posodice in brizge za peroralno dajanje (glede brizge za peroralno dajanje se posvetujte s farmacevtom):
English: Pregnancy:
Slovenian: Nosečnost:
English: The recommended adult dose of REYATAZ capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Slovenian: Priporočeni odmerek zdravila REYATAZ kapsule za odrasle je 300 mg enkrat na dan s 100 mg ritonavirja enkrat na dan in skupaj s hrano, v kombinaciji z drugimi zdravili proti HIV.
English: Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Slovenian: Ena škatla vsebuje 60 x 1 kapsulo; 10 pretisnih omotov s 6 x 1 kapsulo v enoodmernem alu/alu perforiranem pretisnem omotu.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja.
English: Capsules should be swallowed whole.
Slovenian: Kapsule morate pogoltniti cele.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vrečica z 1,5 g peroralnega praška vsebuje 50 mg atazanavirja (v obliki sulfata).
English: Give to your child the recommended dose of ritonavir immediately after giving REYATAZ oral powder.
Slovenian: Otroku takoj po zdravilu REYATAZ peroralni prašek dajte še priporočeni odmerek ritonavirja.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Slovenian: Ena škatla vsebuje 30 x 1 kapsulo; 5 pretisnih omotov s 6 x 1 kapsulo v enoodmernem alu/alu perforiranem pretisnem omotu.
English: REYATAZ/ritonavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Slovenian: Zdravila REYATAZ/ritonavirja se ne sme uporabljati skupaj z zdravili, ki so substrat za CYP3A4 in imajo ozek terapevtski indeks.
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ capsules).
Slovenian: Glejte tabelo za odmerjanje posamezne farmacevtske oblike (glejte povzetek glavnih značilnosti zdravila REYATAZ kapsule).
English: g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
Slovenian: g Izbrane substitucije vključujejo katero koli spremembo na pozicijah L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84 in L90 (0-2, 3, 4 ali več) ob izhodišču.
English: Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69%
Slovenian: Buprenorfin AUC ↑67% Buprenorfin Cmax ↑37% Buprenorfin Cmin ↑69%
English: At Week 48 there were 134 paediatric patients aged 3 months to less than 11 years that received REYATAZ oral powder with ritonavir that were evaluated for efficacy.
Slovenian: V 48. tednu je bila učinkovitost ovrednotena pri 134 pediatričnih bolnikih, starih od 3 mesece do manj kot 11 let, ki so prejemali zdravilo REYATAZ v obliki peroralnega praška z ritonavirjem.
English: Two percent of patients treated with REYATAZ experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Slovenian: Dva odstotka bolnikov, ki so prejemali zdravilo REYATAZ, sta imela sočasno zvišanje ALT/AST 3. oz. 4. stopnje in zvišanje celotnega bilirubina 3. oz. 4. stopnje.
English: Put the oral syringe tip into the mixture and pull back the plunger until the full amount of infant formula is taken up.
Slovenian: Konico brizge za peroralno dajanje namestite v mešanico in bat vlecite nazaj, dokler v brizgo ne izvlečete celotno količino začetne formule za dojenčke.
English: REYATAZ should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Slovenian: Zdravila REYATAZ se ne sme uporabljati skupaj z zdravili, ki so substrat za CYP3A4 in imajo ozek terapevtski indeks.
English: Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of REYATAZ/ritonavir with these medicinal products is not expected to significantly alter the exposure of the coadministered medicinal products.
Slovenian: Na osnovi teh podatkov in ker pomembnejšega vpliva ritonavirja na farmakokinetiko NRTI-jev ne pričakujemo, pri sočasni uporabi zdravila REYATAZ/ritonavirja s temi zdravili ne pričakujemo, da bi se izpostavljenost sočasno uporabljenim zdravilom pomembneje spremenila.
English: B: To mix the recommended number of REYATAZ oral powder sachets with a beverage such as milk or water in a small drinking cup: A spoon is used to mix the content of the sachets with 30 ml of the beverage.
Slovenian: B: Priprava mešanice priporočenega števila vrečic zdravila REYATAZ peroralni prašek z napitkom, kot je mleko ali voda, v manjšem kozarcu: Z žlico zmešajte vsebino vrečic s 30 ml napitka.
English: Treatment-Naive REYATAZ Powder/ritonavir n=52
Slovenian: Predhodno še nezdravljeni bolniki REYATAZ prašek/ritonavir n=52
English: Choose the appropriate option listed below for giving REYATAZ oral powder to your child.
Slovenian: Izberite enega od v nadaljevanju navedenih načinov dajanja zdravila REYATAZ peroralni prašek, ki ustreza otroku.
English: REYATAZ oral powder contains 1305.15 mg of sucrose per sachet.
Slovenian: Zdravilo REYATAZ peroralni prašek vsebuje 1.305,15 mg saharoze na vrečico.
English: Atazanavir, the active substance of REYATAZ, is excreted in human milk.
Slovenian: Atazanavir, učinkovina zdravila REYATAZ, se izloča v materino mleko.
English: Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
Slovenian: Bolnike je treba opozoriti, da so med zdravljenjem s shemami, ki so vsebovale zdravilo REYATAZ, poročali o omotici (glejte poglavje 4.8).
English: Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
Slovenian: Pediatrični bolniki (stari od 6 do manj kot 18 let in s telesno maso najmanj 15 kg) Odmerek atazanavirja v obliki kapsul pri pediatričnih bolnikih temelji na njihovi telesni masi, kot prikazuje preglednica 1, in ne sme preseči priporočenega odmerka za odrasle.
English: Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ, based on these data.
Slovenian: Glede na to, da je bilo dokazano, da nizki odmerek ritonavirja (100 mg dvakrat na dan) nima pomembnega vpliva na koncentracije metadona, na osnovi teh podatkov pri sočasni uporabi metadona z zdravilom REYATAZ interakcij ne pričakujemo.
English: uncommon: gynaecomastia
Slovenian: občasni: ginekomastija
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Slovenian: Z analizo "kot so bili zdravljeni" in ob izključitvi manjkajočih vrednosti, je bil delež bolnikov s HIV RNA < 400 kopij/ml (< 50 kopij/ml) za REYATAZ + ritonavir 84% (72%) in za lopinavir + ritonavir 82% (72%).
English: The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Slovenian: Pri laboratorijskih meritvah so pri pediatričnih bolnikih, ki so prejemali zdravilo REYATAZ v obliki peroralnega praška, najpogosteje poročali o povečani koncentraciji celokupnega bilirubina (≥ 2,6-krat nad zgornjo mejo referenčnih vrednosti, stopnja 3-4; 16%) in zvišanju vrednosti amilaze (stopnja 3-4; 33%), ki je običajno bilo nepankreasnega porekla.
English: Each carton contains 30 sachets.
Slovenian: Ena škatla vsebuje 30 vrečic.
English: REYATAZ capsules must be taken with ritonavir and have to be taken with food.
Slovenian: Kapsule REYATAZ je treba jemati skupaj z ritonavirjem in skupaj s hrano.
English: 50 to <100 cells/mm3
Slovenian: 50 do <100 celic/mm3
English: 100 to <200 cells/mm3
Slovenian: 100 do <200 celic/mm3
English: REYATAZ oral powder should be taken/given with food (e.g. applesauce or yogurt) or drinks (e.g. milk, infant formula or water) for infants who can drink from a cup.
Slovenian: Dojenčkom, ki lahko pijejo iz kozarca, je treba zdravilo REYATAZ peroralni prašek dajati skupaj s hrano (npr. jabolčna čežana ali jogurt) ali napitkom (npr. mleko, začetna formula za dojenčke ali voda).