FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 mg twice daily (every 12 hours) 40 mg twice daily (every 12 hours)
Slovenian: 30 mg dvakrat na dan (na 12 ur) 40 mg dvakrat na dan (na 12 ur)
English: 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.
Slovenian: 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).
English: 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
Slovenian: 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
English: If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger.
Slovenian: 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.
English: 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.
Slovenian: 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%).
English: Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis has been reported with the use of stavudine.
Slovenian: Laktacidoza: Med uporabo stavudina je bila opisana laktacidoza, ponavadi skupaj s hepatomegalijo in steatozo jeter.
English: Blanchardstown Corporate Park 2 Dublin 15, D15 T867
Slovenian: Blanchardstown Corporate Park 2 Dublin 15
English: 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).
Slovenian: 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).
English: In HIV-infected patients, total clearance of stavudine is 594±164 ml/min, and renal clearance is 237±98 ml/min.
Slovenian: Pri z virusom HIV okuženih bolnikih skupni očistek stavudina znaša 594±164 ml/min, ledvični očistek pa 237±98 ml/min.
English: Store in the original package in order to protect from excessive moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Slovenian: Še posebej ogroženi utegnejo biti bolniki, ki so hkrati okuženi z virusom hepatitisa C in se zdravijo z interferonom alfa in ribavirinom.
English: 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).
Slovenian: 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).
English: Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.
Slovenian: Zerit 200 mg prašek za peroralno raztopino je na voljo v plastenki, ki vsebuje 200 ml raztopine.
English: It occurs in ~1% of patients receiving stavudine.
Slovenian: Ta mutacija se pojavi pri približno 1% bolnikov, ki se zdravijo s stavudinom.
English: Zerit 15 mg hard capsules Zerit 20 mg hard capsules Zerit 30 mg hard capsules Zerit 40 mg hard capsules
Slovenian: Zerit 15 mg trde kapsule Zerit 20 mg trde kapsule Zerit 30 mg trde kapsule Zerit 40 mg trde kapsule
English: 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.
Slovenian: 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.
English: common: diarrhoea, abdominal pain, nausea, dyspepsia uncommon: pancreatitis, vomiting
Slovenian: pogosti:diareja, bolečine v trebuhu, navzea, dispepsija občasni: pankreatitis, bruhanje
English: UNIQUE IDENTIFIER - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Zunanja ovojnina: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Za najboljšo absorpcijo je treba kapsule zaužiti s kozarcem vode, po možnosti vsaj eno uro pred obrokom in na prazen želodec.
English: 15 mg twice daily 15 mg every 24 hours
Slovenian: 15 mg dvakrat na dan 15 mg na 24 ur
English: Excipients: the reconstituted powder for oral solution contains 50 mg sucrose per ml of reconstituted solution.
Slovenian: Pomožne snovi: Pripravljeni prašek za peroralno raztopino vsebuje 50 mg saharoze na ml pripravljene raztopine.
English: When such development is found, treatment with Zerit should not be continued (see section 4.4).
Slovenian: Če se ugotovi, da se razvija lipoatrofija, je treba zdravljenje z zdravilom Zerit prekiniti (glejte poglavje 4.4).
English: V75T is selected in vitro by stavudine and reduces susceptibility to stavudine by 2-fold.
Slovenian: Stavudin in vitro povzroči selekcijo mutacije V75T, kar občutljivost za stavudin zmanjša za 2-krat.
English: Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Slovenian: Pretisni omoti iz aclar/aluminija s 14 trdimi kapsulami v pretisnem omotu in 4 pretisnimi omoti (56 trdih kapsul) v škatli.
English: Store below 25°C (aclar/alu blisters).
Slovenian: Shranjujte pri temperaturi do 25°C (aclar/alu pretisni omoti).
English: LIST OF EXCIPIENTS Lactose
Slovenian: SEZNAM POMOŽNIH UČINKOVIN Laktoza
English: Metabolic parameters: weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Slovenian: Presnovni parametri: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
English: Lipoatrophy: on the basis of mitochondrial toxicity stavudine has been shown to cause loss of subcutaneous fat, which is most evident in the face, limbs and buttocks.
Slovenian: Lipoatrofija: V povezavi s toksičnostjo za mitohondrije se je pokazalo, da stavudin povzroča izgubo podkožnega maščevja, ki je najbolj opazna na obrazu, udih in zadnjici.
English: In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅h/ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ml (27%), and Cmin was 9±8 ng/ml (89%).
Slovenian: Pri osmih bolnikih, ki so dobivali 40 mg dvakrat na dan na tešče, je bila AUC0-12h v stanju dinamičnega ravnovesja 1284 ± 227 ng⋅ur/ml (18%) (srednja vrednost ± SD [% IZ]), Cmax 536 ± 146 ng/ml (27%) in Cmin 9 ± 8 ng/ml (89%).
English: It is recommended that HIV infected women should not breast-feed under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo je, da s HIV okužene ženske ne dojijo, da ne bi prišlo do prenosa HIV.
English: Pancreatitis was reported in < 1% of patients in combination therapy studies with Zerit.
Slovenian: V študijah kombiniranega zdravljenja z zdravilom Zerit so pankreatitis zabeležili pri < 1% bolnikov.
English: Children older than 3 months, whose body weight is less than 30 kg, should receive 1 mg/kg twice daily.
Slovenian: Otroci, ki so starejši od 3 mesecev, a tehtajo manj kot 30 kg, morajo dobiti 1 mg/kg dvakrat na dan.
English: Lipoatrophy: stavudine has been shown to cause loss of subcutaneous fat, which is most evident in the face, limbs and buttocks.
Slovenian: Lipoatrofija: Pokazalo se je, da stavudin povzroča izgubo podkožnega maščevja, ki je najbolj opazna na obrazu, udih in zadnjici.
English: The capsule shells are marked using edible black printing ink containing shellac, propylene glycol, purified water, potassium hydroxide and iron oxide (E172).
Slovenian: Oznake na ovojnici kapsule so natisnjene z užitnim črnim črnilom, ki vsebuje: šelak, propilenglikol, prečiščeno vodo, kalijev hidroksid in železov oksid (E172).
English: HDPE bottles with child resistant screw cap (60 hard capsules per bottle).
Slovenian: HDPE plastenke z za otroke varno navojno zaporko (60 trdih kapsul v eni plastenki).
English: Also listed are adverse reactions observed post-marketing in association with stavudine-containing antiretroviral treatment.
Slovenian: Navedeni so tudi neželeni učinki, ki so jih v povezavi s protiretrovirusnim zdravljenjem, ki vključuje stavudin, opazili pri spremljanju zdravila na tržišču.
English: For children whose body weight is 30 kg or more, the usual starting dose is 30 or 40 mg given twice daily (with approximately 12 hours between each dose).
Slovenian: Pri otrocih s telesno maso vsaj 30 kg je običajni začetni odmerek 30 ali 40 mg dvakrat na dan (s približno 12-urnim presledkom med odmerki).
English: Children at least 14 days old whose body weight is less than 30 kg, should receive 1 mg/kg twice daily.
Slovenian: Otroci, stari vsaj 14 dni, ki tehtajo manj kot 30 kg, morajo dobiti 1 mg/kg dvakrat na dan.
English: Rare (may affect up to 1 in 1,000 people) anemia hyperglycaemia (high sugar levels in the blood)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) anemija hiperglikemija (zvišana koncentracija sladkorja v krvi)
English: common: lipoatrophy**, asymptomatic hyperlactatemia uncommon: lactic acidosis (in some cases involving motor weakness), anorexia rare: hyperglycaemia* very rare: diabetes mellitis*
Slovenian: Presnovne in prehranske motnje: pogosti: lipoatrofija**, asimptomatska hiperlaktatemija občasni: laktacidoza (ki v nekaterih primerih vključuje motorično šibkost), anoreksija redki: hiperglikemija* zelo redki: sladkorna bolezen*
English: When such development is found, discontinuation of Zerit should be considered.
Slovenian: Če se ti simptomi pojavijo, je treba razmisliti o prekinitvi zdravljenja z zdravilom Zerit.
English: To obtain optimal absorption, Zerit should be taken at least one hour before a meal and on an empty stomach.
Slovenian: Za najboljšo absorpcijo je treba zdravilo Zerit zaužiti vsaj eno uro pred obrokom in na prazen želodec.
English: Rare (may affect up to 1 in 1,000 people) anemia hyperglycaemia (high sugar levels in the blood) hepatic steatosis (fat in the liver)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) anemija hiperglikemija (zvišana koncentracija sladkorja v krvi) jetrna steatoza (čezmerno kopičenje maščobe v jetrih)
English: The ingredients of the capsule shell are gelatine, iron oxide colorant (E172), silicon dioxide, sodium laurilsulphate and titanium dioxide colorant (E171).
Slovenian: Sestavine ovojnice kapsule so: želatina, železov oksid kot barvilo (E172), silicijev dioksid, natrijev lavrilsulfat in titanov dioksid kot barvilo (E171).
English: Immune reactivation syndrome: in HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: 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 okužbe.
English: The solution should be dispensed with the measuring cup provided, or for doses less than 10 ml, dispense with a syringe.
Slovenian: Raztopino odmerjajte s priloženo odmerno čašo, odmerke, manjše od 10 ml, pa z brizgo.
English: If you have taken too much of the solution, or if someone accidentally swallows some, there is no immediate danger.
Slovenian: Če ste vzeli večji odmerek zdravila Zerit, kot bi smeli Če vzamete preveč raztopine ali jo kdo pomotoma zaužije, ni nobene neposredne nevarnosti.
English: The incidence and severity of lipoatrophy are cumulative over time with stavudine-containing regimens.
Slovenian: Incidenca in resnost lipoatrofije se pri zdravljenju s stavudinom povečujeta s časom.
English: Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including Zerit.
Slovenian: Pri bolnikih, ki so prejemali kombinirano protiretrovirusno zdravljenje, ki je vključevalo tudi zdravilo Zerit, so v redkih primerih poročali o motorični oslabelosti.
English: The other ingredients of the powder are: cherry flavour, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers and sucrose.
Slovenian: Pomožne snovi praška so: aroma češnje, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), koloidni silicijev dioksid, simetikon, natrijev karmelozat, sorbinska kislina, stearatni emulgatorji in saharoza.
English: common: rash, pruritus uncommon: urticaria
Slovenian: pogosti: izpuščaj, pruritus občasni: urtikarija
English: Zerit has been studied in combination with other antiretroviral agents, e.g. didanosine, lamivudine, ritonavir, indinavir, saquinavir, efavirenz, and nelfinavir.
Slovenian: Zdravilo Zerit so raziskali v kombinaciji z drugimi protiretrovirusnimi zdravili, npr. z didanozinom, lamivudinom, ritonavirjem, indinavirjem, sakinavirjem, efavirenzom in nelfinavirjem.
English: 0.5 mg/kg twice daily (every 12 hours)
Slovenian: 0,5 mg/kg dvakrat na dan (na 12 ur)
English: Uncommon (may affect up to 1 in 100 people) lactic acidosis (build up of acid in your blood) in some cases involving motor weakness (weakness in your arms, legs or hands) gynaecomastia (breast enlargement in men) anorexia (loss of appetite), anxiety, emotional lability pancreatitis (inflammation of the pancreas), vomiting hepatitis (inflamation of the liver), jaundice (yellow of the skin or eyes) urticaria (itchy rash), arthralgia (joint pain) myalgia (aching muscles), asthenia (unusual tiredness or weakness)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) laktacidoza (zastajanje kisline v krvi), ki v nekaterih primerih vključuje tudi šibkost rok ali nog ginekomastija (povečanje prsi pri moških) anoreksija (izguba apetita), tesnoba, čustvena labilnost pankreatitis (vnetje trebušne slinavke), bruhanje hepatitis (vnetje jeter), zlatenica (rumeno obarvanje kože ali oči) koprivnica (srbeč izpuščaj), artralgija (bolečina v sklepih) mialgija (bolečina v mišicah), astenija (neobičajna utrujenost ali šibkost)
English: Common (may affect up to 1 in 10 people) asymptomatic hyperlactatemia (build up of acid in your blood) lipoatrophy depression peripheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis (numbness, weakness, tingling or pain in the arms and legs) dizziness, abnormal dreams, headache insomnia (difficulty sleeping), somnolence (sleepiness), abnormal thinking diarrhoea, abdominal pain (stomach pain of discomfort) nausea, dyspepsia (indigestion) rash, pruritus (itching) fatigue (extreme tiredness)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) asimptomatska hiperlaktatemija (zastajanje kisline v krvi) lipoatrofija, depresija periferni nevrološki simptomi, vključno s periferno nevropatijo, parstezijo in perifernim nevritisom (otrplost, šibkost, mravljinčenje ali bolečina v rokah in nogah) omotica, nenormalne sanje, glavobol insomnija (nespečnost), somnolenca (zaspanost), nenormalno mišljenje, driska, bolečina v trebuhu (neprijetna bolečina v želodcu), slabost, dispepsija (prebavne motnje) izpuščaj, pruritus (srbenje) izčrpanost (izredna utrujenost)
English: The reconstituted solution contains 1 mg of stavudine per ml.
Slovenian: Rekonstituirana raztopina vsebuje 1 mg stavudina na mililiter.
English: No evidence of impaired fertility was seen in rats at high exposure levels (up to 216 times that observed at the recommended clinical dose).
Slovenian: Pri podganah, ki so bile izpostavljene visokim koncentracijam (216-krat večjim kot pri priporočenem kliničnem odmerku), niso našli dokazov o vplivu na sposobnost razmnoževanja.
English: In the stavudine containing arms, the neonates were treated for 6 weeks with stavudine 1 mg/kg BID.
Slovenian: V kraku s stavudinom so novorojenčke 6 tednov zdravili z 1 mg stavudina/kg dvakrat na dan.
English: For adults whose body weight is 30 kg or more, the usual starting dose is 30 or 40 mg given twice daily (with approximately 12 hours between each dose).
Slovenian: Običajni začetni odmerek za odrasle s telesno maso vsaj 30 kg je 30 ali 40 mg dvakrat na dan (s približno 12-urnim presledkom med odmerki).
English: Dual energy x-ray absorptiometry (DEXA) scans demonstrated overall limb fat loss in stavudine treated patients compared to limb fat gain or no change in patients treated with other NRTIs (abacavir, tenofovir or zidovudine).
Slovenian: Slikanje z dvoenergijsko rentgensko absorpciometrijo (DEXA) je pokazalo, da se je pri bolnikih, ki se zdravijo s stavudinom, v celoti zmanjšala količina maščevja na okončinah v primerjavi z bolniki, ki se zdravijo z drugimi nukleozidnimi in nukleotidnimi zaviralci reverzne transkriptaze (abakavir, tenofovir ali zidovudin), pri katerih se je količina maščevja na okončinah povečala ali pa se ni spremenila.
English: There are no dosage recommendations for paediatric patients under the age of 3 months with renal impairment.
Slovenian: Za otroke z okvaro ledvic, mlajše od 3 mesecev, ni priporočil glede odmerjanja.
English: 1 mg/kg twice daily (every 12 hours)
Slovenian: 1 mg/kg dvakrat na dan (na 12 ur)
English: Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine (see section 4.3).
Slovenian: Nepriporočljive kombinacije: Pri bolnikih, okuženih s HIV, ki so prejemali stavudin skupaj s hidroksisečnino in didanozinom (glejte poglavje 4.3), so poročali o pankreatitisu (usodnem in neusodnem) in periferni nevropatiji (ki je bila v nekaterih primerih huda).
English: C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and faeces, respectively.
Slovenian: označenega stavudina približno 95% skupne radioaktivnosti izločilo z urinom, 3% pa z blatom.
English: What Zerit contains
Slovenian: Kaj vsebuje zdravilo Zerit
English: Each hard capsule contains 79.53 mg of lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 79,53 mg laktoze monohidrata.
English: No significant accumulation of stavudine is observed with repeated administration every 6, 8, or 12 hours.
Slovenian: Po ponavljajoči uporabi na 6, 8 ali 12 ur niso ugotovili pomembnega kopičenja stavudina.
English: Neutropenia (< 750 cells/mm3) was reported in 5%, thrombocytopenia (platelets < 50,000/mm3) in 2%, and low haemoglobin (< 8 g/dl) in < 1% of patients receiving Zerit.
Slovenian: O nevtropeniji (< 750 celic/mm3) so poročali pri 5%, trombocitopeniji (trombociti < 50.000/mm
English: Each bottle contains 200 mg of stavudine.
Slovenian: Ena plastenka vsebuje 200 mg stavudina.
English: Zerit 20 mg hard capsules are brown and marked with “BMS 1965” on one side and “20” on the other side.
Slovenian: Zerit 20 mg trde kapsule so rjave in imajo oznako “BMS 1965” na eni strani in “20” na drugi strani.
English: Potassium Hydroxide
Slovenian: hidroksisečnino in didanozinom.
English: However, lactic acidosis, sometimes fatal, has been reported in pregnant women who received the combination of didanosine and stavudine with or without other anti-retroviral treatment (see sections 4.3 and 4.4).
Slovenian: Vendar je bila pri nosečnicah, ki so dobivale kombinacijo didanozina in stavudina - z drugimi protiretrovirusnimi zdravili ali brez njih - opisana laktacidoza, ki je bila včasih usodna (glejte poglavji 4.3 in 4.4).
English: Zerit 15 mg hard capsules are red and yellow and marked with “BMS 1964” on one side and “15” on the other side.
Slovenian: Zerit 15 mg trde kapsule so rdeče in rumene in imajo oznako “BMS 1964” na eni strani in “15” na drugi strani.
English: Zerit 40 mg hard capsules are dark orange and marked with “BMS 1967” on one side and “40” on the other side.
Slovenian: Zerit 40 mg trde kapsule so temno oranžne in imajo oznako “BMS 1967” na eni strani in “40” na drugi strani.
English: Both studies were designed to compare two formulations of Zerit, one of which was the marketed formulation dosed as currently approved in product labelling.
Slovenian: Namen obeh študij je bil primerjati dve obliki zdravila Zerit.
English: Each hard capsule contains 40.42 mg of lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 40,42 mg laktoze monohidrata.
English: Zerit contains lactose
Slovenian: Zdravilo Zerit vsebuje laktozo
English: Hepatitis or liver failure, which was fatal in some cases, has been reported with the use of stavudine (see section 4.4).
Slovenian: Med uporabo stavudina so poročali o hepatitisu ali odpovedi jeter, ki je bila v nekaterih primerih usodna (glejte poglavje 4.4).
English: If you have problems swallowing capsules you should ask your doctor about the possibility of changing to the solution form of this medicine or you could carefully open the capsule and mix its contents with some food.
Slovenian: Če imate težave s požiranjem kapsul, zdravnika vprašajte o možnosti za njihovo zamenjavo s tekočo obliko zdravila.
English: NAME OF THE MEDICINAL PRODUCT Zerit 200 mg powder for oral solution Stavudine
Slovenian: IME ZDRAVILA Zerit 200 mg prašek za peroralno raztopino stavudin
English: Each hard capsule contains 60.66 mg of lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 60,66 mg laktoze monohidrata.