natgillin/translations-raw huggingface dataset:
Given these potential risks, a benefit-risk assessment for each patients should be made and an alternative antiretroviral should be carefully considered (see Lactic acidosis, Lipoatrophy, and Peripheral neuropathy below and section 4.8).
Zaradi teh možnih tveganj je potrebno pri vsakem bolniku oceniti koristi in tveganja ter natančno razmisliti o drugih možnostih protiretrovirusnega zdravljenja (glejte Laktacidoza, Lipoatrofija ter Periferna nevropatija spodaj in poglavje 4.8).
Mitochondrial dysfunction: review of the postmarketing safety database shows that adverse reactions indicative of mitochondrial dysfunction have been reported in the neonate and infant population exposed to one or more nucleoside analogues (see also section 4.4).
Moteno delovanje mitohondrijev: Pregled zbirke podatkov o varnosti, zbranih v obdobju po pridobitvi dovoljenja za promet, kaže, da so se v populaciji novorojenčkov in dojenčkov, izpostavljenih enemu ali več nukleozidnim analogom, pojavili neželeni učinki, ki nakazujejo moteno delovanje mitohondrijev (glejte tudi poglavje 4.4).
A study in asymptomatic patients demonstrated that systemic exposure is similar while Cmax is lower and Tmax is prolonged when stavudine is administered with a standardised, high-fat meal compared with fasting conditions.
Raziskava pri asimptomatskih bolnikih je pokazala, da je v primeru uporabe stavudina s standardiziranim, zelo mastnim obrokom, sistemska izpostavljenost podobna kot v pogojih na tešče, medtem ko je Cmax manjša, tmax pa daljši.
The powder contains 200 mg stavudine.
Prašek vsebuje 200 mg stavudina.
Cmax and AUC increased proportionally with dose in the dose ranges, intravenous 0.0625-0.75 mg/kg, and oral 0.033-4.0 mg/kg.
Cmax in AUC sta se v območju intravenskih odmerkov od 0,0625 do 0,75 mg/kg in peroralnih od 0,033 do 4,0 mg/kg zvečevali sorazmerno.
What Zerit looks like and content of the pack
Izgled zdravila Zerit in vsebina pakiranja
No carcinogenicity was noted at doses of 400 mg/kg/day in mice and 600 mg/kg/day in rats, corresponding to exposures ~ 39 and 168 times the expected human exposure, respectively, suggesting an insignificant carcinogenic potential of stavudine in clinical therapy.
Ob odmerkih 400 mg/kg/dan pri miših oz. 600 mg/kg/dan pri podganah (ki ustrezata izpostavljenosti ~ 39- oz. 168-krat pričakovani izpostavljenosti pri človeku) niso zabeležili kancerogenosti, kar nakazuje, da je kancerogeni potencial stavudina med kliničnim zdravljenjem nepomemben.
CD4 Mean Change from Baseline, cells/mm3 All patients
Srednja sprememba vrednosti števila celic CD4 od izhodišča, celice/mm3 Vsi bolniki
Stavudine therapy is associated with several severe side effects, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism is mitochondrial toxicity.
Zdravljenje s stavudinom je povezano s številnimi hudimi neželenimi učinki, kot so laktacidoza, lipoatrofija in polinevropatija, za katere je možen mehanizem nastanka mitohondrijska toksičnost.
SPECIAL STORAGE CONDITIONS Store below 25°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25°C.
If you notice any symptoms of infection, please inform your doctor immediately.
Če opazite kakršnekoli znake okužbe, o tem nemudoma obvestite svojega zdravnika.
If this is not possible, Zerit may also be taken with a light meal.
Če to ni mogoče, se lahko zdravilo Zerit vzame tudi z lahkim obrokom.
The total clearance of stavudine appears to be higher in HIV-infected patients, while the renal clearance is similar between healthy subjects and HIV-infected patients.
Kaže, da je celotni očistek stavudina pri bolnikih, okuženih z virusom HIV, večji, ledvični očistek pa podoben kot pri zdravih prostovoljcih.
Preliminary safety data from this study (see also section 4.8), showed an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Preliminarni podatki o varnosti iz te raziskave (glejte tudi poglavje 4.8) kažejo večjo umrljivost dojenčkov (10%) v skupini, zdravljeni s stavudinom in didanozinom, kot v skupinah, zdravljenih s stavudinom (2%), didanozinom (3%) ali zidovudinom (6%).
No notable differences in the frequency of adverse drug reactions were seen between treatment groups.
Med terapevtskimi skupinami niso ugotovili opaznih razlik v pogostnosti neželenih učinkov na zdravilo.
During therapy with Zerit there is often a gradual loss of subcutaneous fat (fat found beneath the skin), which is most notable in the face and on the legs and arms.
Med zdravljenjem z zdravilom Zerit je pogosta postopna izguba podkožnega maščevja (maščevje, ki se nahaja pod kožo), ki je najbolj opazna na obrazu, udih in zadnjici.
If you are taking didanosine, used to treat HIV infection
če jemljete didanozin, ki se uporablja za zdravljenje okužbe z virusom HIV
How to take Zerit
Kako jemati zdravilo Zerit
Intra- and interindividual variation in pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Intra- in interindividualne razlike v farmakokinetičnih značilnostih stavudina po peroralni uporabi so majhne (približno 15% intra- in 25% interindividualno).
Do not store the dry powder above 30°C.
Suhi prašek shranjujte pri temperaturi do 30 °C.
The profile of the adverse events for newborns and infants ≤ 3 months of age showed increases in lactic acid levels, neutropenia, anaemia, thrombocytopenia, hepatic transaminase increases and increased lipids, including hypertriglyceridaemia.
Značilnosti neželenih učinkov pri novorojenčkih in dojenčkih, starih ≤ 3 mesece, so bile zvečanje koncentracije mlečne kisline, nevtropenija, anemija, trombocitopenija, zvišanje jetrnih transaminaz in zvišanje lipidov, vključno s hipertrigliceridemijo.
Stavudine, a thymidine analogue, is phosphorylated by cellular kinases to stavudine triphosphate which inhibits HIV reverse transcriptase by competing with the natural substrate, thymidine triphosphate.
Timidinski analog stavudin celične kinaze fosforilirajo v stavudintrifosfat, ki zavira reverzno transkriptazo HIV, ker tekmuje z naravnim substratom, timidintrifosfatom.
For optimal absorption, Zerit should be taken on an empty stomach (i.e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Za optimalno absorpcijo mora bolnik zdravilo Zerit vzeti na prazen želodec (to je vsaj 1 uro pred obrokom), če pa to ni mogoče, ga lahko vzame tudi skupaj z lahkim obrokom.
When these signs occur, Zerit should be stopped and your HIV treatment changed.
Če se ti znaki pojavijo, je treba prekiniti zdravljenje z zdravilom ZERIT ter spremeniti vaše zdravljenje za HIV.
Adverse reactions of moderate or greater severity with at least a possible relationship to treatment regimen (based on investigator attribution) reported from 467 patients treated with Zerit in combination with lamivudine and efavirenz in two randomised clinical trials and along-term follow-up study (follow-up: median 56 weeks ranging up to 119 weeks) are listed below.
Neželeni učinki (zmerni do hudi), ki bi lahko bili povezani z zdravljenjem (na osnovi presoje raziskovalca) in o katerih so poročali pri 467 bolnikih, zdravljenih z zdravilom Zerit v kombinaciji z lamivudinom in efavirenzom v dveh randomiziranih kliničnih preskušanjih in v potekajoči dolgoročni spremljevalni študiji (srednja vrednost skupnega časa spremljanja: 56 tednov z razponom do 119 tednov), so navedeni spodaj.
Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART - combination antiretroviral therapy) ali obojim.
common: peripheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis; dizziness; abnormal dreams; headache, insomnia; abnormal thinking; somnolence very rare: motor weakness* (most often reported in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome)
pogosti: periferni nevrološki simptomi, vključno s periferno nevropatijo, parestezijami in perifernim nevritisom; omotica; nenormalne sanje; glavobol, nespečnost; nenormalno mišljenje; zaspanost zelo redki: motorična šibkost* (najpogosteje opisana v primeru simptomatske hiperlaktatemije ali sindroma laktacidoze)
uncommon: hepatitis or jaundice rare: hepatic steatosis* very rare: liver failure*
občasni: hepatitis ali zlatenica redki: hepatična steatoza* zelo redki: odpoved jeter*
The mean terminal elimination half-life of stavudine is 1.3 to 2.3 hours following single or multiple doses, and is independent of dose.
Po enkratnem in ponavljajočih se odmerkih srednji končni razpolovni čas izločanja stavudina znaša od 1,3 do 2,3 ure in ni odvisen od odmerka.
Peripheral neuropathy: if symptoms of peripheral neuropathy develop (usually characterised by persistent numbness, tingling, or pain in the feet and/or hands) (see section 4.4), patients should be switched to an alternative treatment regimen, if appropriate.
Periferna nevropatija: Če se pojavijo simptomi periferne nevropatije (njena značilnost so ponavadi dolgotrajna omrtvelost, mravljinčenje ali bolečine v stopalih in/ali dlaneh) (glejte poglavje 4.4), je treba zdravljenje zamenjati z alternativnim, če je to primerno.
These studies include ACTG 240, where 105 paediatric patients ages 3 months to 6 years received Zerit 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received Zerit 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received Zerit 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.
Te raziskave vključujejo ACTG 240, v kateri je 105 pediatričnih bolnikov, starih od 3 mesece do 6 let, dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan 6,4 mesece (srednja vrednost trajanja terapije); kontrolirano klinično raziskavo, v kateri je 185 novorojenčkov dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan bodisi samega ali v kombinaciji z didanozinom, in sicer od rojstva do 6 tednov starosti ter klinično raziskavo, v kateri je 8 novorojenčkov dobivalo zdravilo Zerit v odmerku 2 mg/kg/dan v kombinaciji z didanozinom in nelfinavirom od rojstva do 4 tedna starosti.
To help protect the capsules from excessive moisture, the bottle includes a desiccant canister.
Za zaščito kapsul pred čezmerno vlago je v plastenki tudi vložek s sušilom.
Treatment with stavudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Če se pojavijo simptomatska hiperlaktatemija in metabolična acidoza/laktacidoza, napredujoča hepatomegalija ali hitro zviševanje aminotransferaz, je treba zdravljenje s stavudinom prekiniti.
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Zgodnji simptomi (simptomatska hiperlaktatemija) vključujejo blage prebavne težave (navzeo, bruhanje in bolečine v trebuhu), nespecifično splošno slabo počutje, izgubo teka, hujšanje, respiratorne simptome (hitro in/ali globoko dihanje) ali nevrološke simptome (vključno z motorično šibkostjo).
Data on lactic acid in serum were not collected in this study.
V tej raziskavi niso zbirali podatkov o mlečni kislini v serumu.
Each bottle contains 31.5 mg of propylhydroxybenzoate (E216) Each bottle contains 315 mg of methylhydroxybenzoate (E218) Each bottle contains 10.15 g of sucrose
Ena plastenka vsebuje 31,5 mg propilparahidroksibenzoata (E216) Ena plastenka vsebuje 315 mg metilparahidroksibenzoata (E218) Ena plastenka vsebuje 10,15 g saharoze
Liver disease: hepatitis or liver failure, which was fatal in some cases, has been reported.
Bolezni jeter: Opisani so primeri hepatitisa ali odpovedi jeter, ki je bila v nekaterih primerih usodna.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (over the age of 3 months) only when other antiretrovirals can not be used.
Zdravilo Zerit je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom HIV pri odraslih in otrocih (starejših od 3 mesecev), vendar le, če uporaba drugih protiretrovirusnih zdravil ni mogoča.
Co-administration with didanosine due to the potential for serious and/or life-threatening events notably lactic acidosis, liver function abnormalities, pancreatitis and peripheral neuropathy (see sections 4.4 and 4.5).
Sočasna uporaba z didanozinom, zaradi možnosti pojava resnih in/ali življenje ogrožujočih neželenih učinkov, zlasti laktacidoze, nepravilnega delovanja jeter, pankreatitisa ali periferne nevropatije (glejte poglavji 4.4 in 4.5).
HDPE bottle with child resistant screw cap, fill mark (200 ml of solution after reconstitution) and measuring cup.
HDPE plastenka z za otroke varno navojno zaporko, polnilno oznako (200 ml raztopine po pripravi) in odmerno čašo.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
In vitro, stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells (a human T-lymphoblastoid cell line) and peripheral blood mononuclear cells, supporting twice daily dosing.
In vitro na CEM T-celicah (celična linija humanih T-limfoblastoidnih celic) in mononuklearnih celicah iz periferne krvi znotrajcelični razpolovni čas stavudintrifosfata znaša 3,5 ure, kar podpira odmerjanje zdravila dvakrat na dan.
EXPIRY DATE EXP
DATUM IZTEKA ROKA UPORABNOSTI EXP
Metabolites include oxidised stavudine, glucuronide conjugates of stavudine and its oxidised metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.
Presnovki vključujejo oksidirani stavudin, glukuronidne konjugate stavudina in njegove oksidirane presnovke ter N-acetilcisteinski konjugat riboze po glikozidnem cepljenju, kar kaže, da je timin tudi presnovek stavudina.
The decrease of susceptibility in vitro is subtle requiring two or more TAMs (generally M41L and T215Y) before stavudine susceptibility is decreased (> 1.5 fold).
Potrebni sta dve mutaciji timidinskih analogov ali več (običajno M41L in T215Y), preden se občutljivost za stavudin zmanjša (> 1,5-krat).
Immune reactivation syndrome: in HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunske reaktivacije: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used.
Zdravilo Zerit je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom HIV pri odraslih in otrocih (od rojstva), vendar le, če uporaba drugih protiretrovirusnih zdravil ni mogoča.
Keep the bottle tightly closed.
Shranjujte v tesno zaprti plastenki.
20 mg twice daily 20 mg every 24 hours
20 mg dvakrat na dan 20 mg na 24 ur
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Bolnike s kroničnim hepatitisom B ali C, ki dobivajo kombinirano protiretrovirusno zdravljenje, bolj ogrožajo hudi in potencialno usodni neželeni učinki na jetrih.
30 mg twice daily (every 12 hours) 40 mg twice daily (every 12 hours)
30 mg dvakrat na dan (na 12 ur) 40 mg dvakrat na dan (na 12 ur)
Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/or vascular; and urinary bladder carcinomas) at very high exposure levels.
Stavudin je bil pri zelo visoki ravni izpostavljenosti kancerogen pri miših (tumorji jeter) in podganah (tumorji jeter - holangiocelularni, hepatocelularni, mešani hepatoholangiocelularni - in/ali žilni ter karcinomi sečnega mehurja).
Very rare (may affect up to 1 in 10,000 people) thrombocytopenia, neutropenia (blood disorders) diabetes mellitus motor weakness (most often reported in the setting of symptomatic hyperlacetatemia or lactic acidosis syndrome) liver failure
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) trombocitopenija, nevtropenija (bolezni krvi) sladkorna bolezen motorična šibkost (najpogosteje opisana v primeru simptomatske hiperlaktatemije ali sindroma laktacidoze) odpoved jeter
If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger.
Če ste vzeli večji odmerek zdravila Zerit, kot bi smeli Če vzamete preveč kapsul ali če jih kdo pomotoma zaužije nekaj, to ne pomeni nobene neposredne nevarnosti.
There was, however, an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Vendar pa je bila umrljivost dojenčkov v skupini, zdravljeni s stavudinom in didanozinom, večja (10%) kot v skupinah, zdravljenih s stavudinom (2%), didanozinom (3%) ali zidovudinom (6%).
Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis has been reported with the use of stavudine.
Laktacidoza: Med uporabo stavudina je bila opisana laktacidoza, ponavadi skupaj s hepatomegalijo in steatozo jeter.
In randomized controlled trials of treatment-naive patients, clinical lipoatrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir).
V randomiziranih, nadzorovanih preskušanjih pri bolnikih, ki se še niso zdravili, se je klinična lipoatrofija pogosteje razvila pri bolnikih, ki so se zdravili s stavudinom, kot pri bolnikih, ki so se zdravili z drugimi nukleozidi (tenofovir ali abakavir).
In HIV-infected patients, total clearance of stavudine is 594±164 ml/min, and renal clearance is 237±98 ml/min.
Pri z virusom HIV okuženih bolnikih skupni očistek stavudina znaša 594±164 ml/min, ledvični očistek pa 237±98 ml/min.
Store in the original package in order to protect from excessive moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Še posebej ogroženi utegnejo biti bolniki, ki so hkrati okuženi z virusom hepatitisa C in se zdravijo z interferonom alfa in ribavirinom.
If you develop one of the following, contact your doctor: persistent numbness, tingling or pain in feet and/or hands (this may indicate the beginning of peripheral neuropathy, an adverse effect on the nerves), muscular weakness abdominal pain, nausea or vomiting rapid deep breathing, drowsiness (which may indicate pancreatitis, liver disturbance such as hepatitis, or lactic acidosis).
Če se pri vas pojavi kar koli od navedenega, o tem obvestite svojega zdravnika: trdovratna omrtvelost, mravljinčenje ali bolečine v stopalih in/ali dlaneh (to lahko naznanja začetek periferne nevropatije, neželenega učinka na živcih), mišična šibkost bolečine v trebuhu, siljenje na bruhanje ali bruhanje hitro globoko dihanje, zaspanost (ki lahko nakazuje pankreatitis, motnje jeter, npr. hepatitis, ali laktacidozo).
Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.
Zerit 200 mg prašek za peroralno raztopino je na voljo v plastenki, ki vsebuje 200 ml raztopine.
It occurs in ~1% of patients receiving stavudine.
Ta mutacija se pojavi pri približno 1% bolnikov, ki se zdravijo s stavudinom.
Zerit 15 mg hard capsules Zerit 20 mg hard capsules Zerit 30 mg hard capsules Zerit 40 mg hard capsules
Zerit 15 mg trde kapsule Zerit 20 mg trde kapsule Zerit 30 mg trde kapsule Zerit 40 mg trde kapsule
Laboratory abnormalities: laboratory abnormalities reported in these two trials and an ongoing follow-up study included elevations of ALT (> 5 x ULN) in 3%, of AST (> 5 x ULN) in 3%, of lipase (≥ 2.1 ULN) in 3% of the patients in the Zerit group.
Odstopanja od normalnih vrednosti laboratorijskih preiskav: med laboratorijskimi nenormalnostmi, opisanimi v teh dveh raziskavah in v potekajoči spremljevalni raziskavi, so bila zvišanja ALT (> 5 x ZNM) pri 3%, AST (> 5 x ZNM) pri 3% in lipaze (≥ 2,1 ZNM) pri 3% bolnikov v skupini, ki je dobivala zdravilo Zerit.
common: diarrhoea, abdominal pain, nausea, dyspepsia uncommon: pancreatitis, vomiting
pogosti:diareja, bolečine v trebuhu, navzea, dispepsija občasni: pankreatitis, bruhanje
UNIQUE IDENTIFIER - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Zunanja ovojnina: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV infected patients treated with antiretroviral agents and hydroxyurea; fatal hepatic events were reported most often in patients treated with stavudine, hydroxyurea and didanosine.
V obdobju spremljanja zdravila po prihodu na trg so pri bolnikih, okuženih s HIV, ki so prejemali protiretrovirusna zdravila in hidroksisečnino, poročali o hepatotoksičnih učinkih in odpovedi jeter s smrtnim izidom; usodni jetrni dogodki so bili najpogosteje opisani pri bolnikih, ki so se zdravili s stavudinom, hidroksisečnino in didanozinom.
To obtain optimal absorption, the capsules should be swallowed with a glass of water, preferentially at least one hour before a meal and on an empty stomach.
Za najboljšo absorpcijo je treba kapsule zaužiti s kozarcem vode, po možnosti vsaj eno uro pred obrokom in na prazen želodec.
15 mg twice daily 15 mg every 24 hours
15 mg dvakrat na dan 15 mg na 24 ur
Excipients: the reconstituted powder for oral solution contains 50 mg sucrose per ml of reconstituted solution.
Pomožne snovi: Pripravljeni prašek za peroralno raztopino vsebuje 50 mg saharoze na ml pripravljene raztopine.
When such development is found, treatment with Zerit should not be continued (see section 4.4).
Če se ugotovi, da se razvija lipoatrofija, je treba zdravljenje z zdravilom Zerit prekiniti (glejte poglavje 4.4).
V75T is selected in vitro by stavudine and reduces susceptibility to stavudine by 2-fold.
Stavudin in vitro povzroči selekcijo mutacije V75T, kar občutljivost za stavudin zmanjša za 2-krat.
Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Pretisni omoti iz aclar/aluminija s 14 trdimi kapsulami v pretisnem omotu in 4 pretisnimi omoti (56 trdih kapsul) v škatli.
Store below 25°C (aclar/alu blisters).
Shranjujte pri temperaturi do 25°C (aclar/alu pretisni omoti).
LIST OF EXCIPIENTS Lactose
SEZNAM POMOŽNIH UČINKOVIN Laktoza