FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose of Epivir is 0.5 mL/kg (5 mg/kg) twice daily (leaving approximately 12 hours between each dose), or 1 mL/kg (10 mg/kg) once daily.
Slovenian: Običajni odmerek zdravila Epivir je 0,5 ml/kg (5 mg/kg) dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali 1 ml/kg (10 mg/kg) enkrat na dan.
English: Bottle contents: 240 ml oral solution
Slovenian: Vsebina plastenke: 240 ml peroralne raztopine
English: The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral solution.
Slovenian: Za natančno odmerjanje predpisanega odmerka peroralne raztopine je priložena peroralna odmerna brizga.
English: Turn the bottle the correct way up.
Slovenian: Obrnite plastenko v pravilen pokončen položaj.
English: The dose should therefore be adjusted, using oral solution presentation of Epivir for patients whose creatinine clearance falls below 30 ml/min (see tables).
Slovenian: Odmerek je torej potrebno prilagoditi, pri bolnikih, ki imajo kreatininski očistek manjši od 30 ml/min z uvedbo peroralne raztopine Epivir (glejte tabele).
English: Week 0 (After ≥36 Weeks on Treatment) Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Slovenian: 0. teden (po ≥ 36 tednih zdravljenja) HIV-1 RNA v plazmi < 80 kopij/ml Razlika v tveganju (enkrat na dan-dvakrat na dan)
English: Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza (E460) natrijev karboksimetilškrob magnezijev stearat
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Slovenian: Ko so zidovudin dajali z lamivudinom so opazili, da je Cmax zidovudina nekoliko narasla (za 28%), vendar pa se skupna izpostavljenost (AUC) ni znatneje spremenila.
English: Patients changing between lamivudine tablets and lamivudine oral solution should follow the dosing recommendations that are specific for the formulation (see section 5.2).
Slovenian: Bolniki, ki bodo prehajali med tabletami z lamivudinom in peroralno raztopino z lamivudinom morajo slediti priporočilom glede odmerjanja, ki so specifična za določeno formulacijo (glejte poglavje 5.2).
English: The malformative risk is unlikely in humans based on those data.
Slovenian: Na podlagi teh podatkov je verjetnost za pojav malformacijskih učinkov pri človeku majhna.
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Slovenian: Biološka uporabnost peroralnega lamivudina se običajno giblje med 80 in 85%.
English: Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders Rare: Rhabdomyolysis
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni: artralgija, mišične okvare Redki: rabdomioliza
English: It is metabolised intracellularly to the active moiety, lamivudine 5'- triphosphate.
Slovenian: V celici se presnovi v aktivno obliko, lamivudin 5'-trifosfat (TP).
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection,
Slovenian: • če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če ste okuženi z virusom hepatitisa B, ne prenehajte z jemanjem zdravila Epivir brez zdravnikovega navodila, kajti hepatitis se lahko ponovi),
English: Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2)
Slovenian: Bolniki, ki bodo prehajali med peroralno raztopino z lamivudinom in tabletami z lamivudinom morajo slediti priporočilom glede odmerjanja, ki so specifična za določeno formulacijo (glejte poglavje 5.2).
English: Children weighing at least 14 kg and less than 20 kg:
Slovenian: Otroci, ki tehtajo vsaj 14 kg in manj kot 20 kg:
English: These may affect up to 1 in 1000 people:
Slovenian: Pojavijo se lahko pri največ 1 od 1000 bolnikov:
English: Film-coated tablets:
Slovenian: Filmsko obložene tablete:
English: Lamivudine has been widely used as a component of antiretroviral combination therapy with other antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse transcriptase inhibitors).
Slovenian: Lamivudin se veliko uporablja v kombinirani protiretrovirusni terapiji z drugimi protiretrovirusnimi zdravili iste skupine (nukleozidni in nukleotidni zaviralci reverzne transkriptaze) ali v kombinaciji s protiretrovirusnimi zdravili iz drugih skupin (zaviralci proteaz, nenukleozidni zaviralci reverzne transkriptaze).
English: Renal impairment: In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see section 4.2).
Slovenian: Ledvična okvara: Zaradi manjšega očistka je pri bolnikih z zmerno do hudo oslabljenim delovanjem ledvic končni razpolovni čas lamivudina podaljšan in tako je potrebno odmerek prilagoditi (glejte poglavje 4.2).
English: Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Slovenian: Na osnovi teh podatkov tako pri bolnikih z zmerno do hudo jetrno okvaro odmerka ni potrebno prilagoditi, vendar slednje velja le v primeru normalnega delovanja ledvic.
English: Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg): Creatinine clearance (ml/min)
Slovenian: Priporočila glede odmerjanja - Odrasli, mladostniki in otroci (ki tehtajo vsaj 25 kg): Kreatininski očistek (ml/min)
English: White, diamond shaped scored tablets engraved with “GX CJ7” on both faces.
Slovenian: Bele tablete v obliki diamanta z zarezo, ki imajo na obeh straneh odtisnjeno oznako“GX CJ7”.
English: Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of lamivudine in plasma are 1.2 µg/ml (24%) and 0.09 µg/ml (27%), respectively.
Slovenian: Na osnovi podatkov iz klinične študije pri zdravih prostovoljcih je, pri terapevtskem odmerku 150 mg dvakrat na dan, srednja (CV) Cmax lamivudina v ravnotežnem stanju 1,2 μg/ml (24%), srednja (CV) Cmin lamivudina v ravnotežnem stanju pa 0,09 μg/ml (27%).
English: Metabolism and nutrition disorders Very rare: Lactic acidosis
Slovenian: Presnovne in prehranske motnje Zelo redki: laktacidoza
English: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 30 tablets
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varnimi zaporkami ali PVC/aluminij pretisni omoti, vsako pakiranje vsebuje po 30 tablet.
English: In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 10.31 (6.26, 17.0) µg.h/ml in the once-daily dosing and 9.24 (4.66, 18.3) µg.h/ml in the twice-daily dosing.
Slovenian: V študiji PENTA 15 je bila geometrična srednja vrednost AUC(0-24) (95 % IZ) lamivudina v plazmi pri štirih preiskovancih, mlajših od 12 mesecev, ki so prešli z režima odmerjanja dvakrat na dan na režim odmerjanja enkrat na dan (glejte poglavje 5.1) 10,31 (6,26; 17,0) µg.h/ml med odmerjanjem enkrat na dan ter 9,24 (4,66; 18,3) µg.h/ml med odmerjanjem dvakrat na dan.
English: Insert the syringe firmly into the adapter.
Slovenian: Odmerno brizgo trdno vstavite v nastavek.
English: Co. Durham DL12 8DT United Kingdom
Slovenian: Harmire Road Barnard Castle Co. Durham DL12 8DT Velika Britanija
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Slovenian: Bolezni kože in podkožja Občasni: kožni izpuščaj, alopecija Redki: angioedem
English: Methyl parahydroxybenzoate Propyl parahydroxybenzoate Each 15 ml dose contains 300 mg propylene glycol.
Slovenian: metilparahidroksibenzoat propilparahidroksibenzoat En 15 ml odmerek vsebuje 300 mg propilenglikola.
English: Respiratory, Thoracic and mediastinal disorders Common: Cough, nasal symptoms
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni: kašelj, nosni simptomi
English: Lamivudine 4 mg/kg TwiceDaily Dosing Geometric Mean (95% Cl)
Slovenian: lamivudin odmerjanje 4 mg/kg dvakrat na dan, geometrična sredina (95 % IZ)
English: Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects.
Slovenian: Nekateri ljudje, ki jemljejo zdravilo Epivir ali druga kombinirana zdravila za zdravljenje okužbe s HIV, so bolj ogroženi zaradi resnih neželenih učnikov.
English: Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Slovenian: Učinkovitosti lamivudina pri bolnikih z virusom HIV, ki so sočasno okuženi z virusom HBV niso posebej preučevali.
English: Epivir contains sucrose.
Slovenian: Zdravilo Epivir vsebuje saharozo.
English: A recommended dosage regimen for patients with creatinine clearance below 50 ml/min is shown in the dosage section (see section 4.2).
Slovenian: Pri bolnikih s kreatininskim očistkom ≤ 50 ml/min je potrebno odmerek zmanjšati (glejte poglavje 4.2).
English: Renal impairment: Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance.
Slovenian: Ledvična okvara: Zaradi manjšega očistka so koncentracije lamivudina pri bolnikih z zmerno do hudo oslabljenim delovanjem ledvic povečane.
English: As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.
Slovenian: Poleg neželenih učinkov zdravila Epivir, ki so navedeni spodaj, se lahko med kombiniranim zdravljenjem okužbe s HIV pojavijo še druge motnje.
English: Twice Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Slovenian: Dvakrat na dan HIV-1 RNA v plazmi < 80 kopij/ml: n/N (%)
English: How to take Epivir
Slovenian: Kako jemati zdravilo Epivir
English: Check with your doctor if you think this applies to you.
Slovenian: Posvetujte se z zdravnikom, če mislite, da se to nanaša na vas.
English: They are grey, diamond shaped film-coated tablets, marked with the code ‘GXEJ7' on one side.
Slovenian: Filmsko obložene tablete so sive barve, v obliki diamanta, na eni strani imajo oznako ‘GXEJ7'.
English: Children weighing at least 20 kg and less than 25 kg:
Slovenian: Otroci, ki tehtajo vsaj 20 kg in manj kot 25 kg:
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Slovenian: Plastenko dobro zaprite s pokrovčkom, pri tem pa pustite plastični nastavek na mestu.
English: Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Slovenian: Dokazano je, da nukleozidni in nukleotidni analogi in vitro in in vivo v različni meri okvarijo mitohondrije.
English: 1206 paediatric patients aged 3 months to 17 years enrolled in the ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in infants and children, 2006).
Slovenian: V okviru randomizirane, multicentrične, kontrolirane študije z virusom HIV okuženih pediatričnih bolnikov, je bila opravljena randomizirana primerjava režima odmerjanja abakavirja in lamivudina enkrat v primerjavi z dvakrat na dan. 1206 pediatričnih bolnikov, starih od 3 mesece do 17 let, so vključili v preskušanje ARROW (COL105677) in so prejemali odmerke v skladu z odmernimi priporočili glede na telesno maso po terapevtskih smernicah Svetovne zdravstvene organizacije (Protiretrovirusno zdravljenje okužbe s HIV pri dojenčkih in otrocih, 2006).
English: 300 mg (30 ml) once daily or
Slovenian: 300 mg (30 ml) enkrat na dan ali
English: Other possible side effects of combination therapy for HIV Combination therapy including Epivir may cause other conditions to develop during HIV treatment.
Slovenian: Drugi možni neželeni učinki kombiniranega zdravljenja okužbe s HIV Kombinirano zdravljenje, ki vključuje zdravilo Epivir lahko med zdravljenjem okužbe s HIV povzroči nastanek drugih motenj.
English: Uncommon: Transient elevations in liver enzymes (AST, ALT) Rare: Hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov Občasni: prehodno zvišanje ravni jetrnih encimov (AST, ALT) Redki: hepatitis
English: Triple nucleoside therapy: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when lamivudine was combined with tenofovir disoproxil fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily regimen.
Slovenian: Zdravljenje s kombinacijo treh nukleozidov: Če so bolniki enkrat na dan prejemali lamivudin v kombinaciji s tenofovir dizoproksilfumaratom in abakavirjem ali v kombinaciji s tenofovir dizoproksil fumaratom in didanozinom, so poročali o visokem odstotku virusnega neodziva in o pojavu odpornosti v zgodnji fazi zdravljenja.
English: What Epivir looks like and the contents of the pack Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution.
Slovenian: Zdravilo Epivir peroralna raztopina je na voljo v belih polietilenskih plastenkah, ki vsebujejo 240 ml raztopine.
English: The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC, Cmax, and tmax.
Slovenian: Glede na AUC∞, Cmax in tmax je 150 mg tableta bioekvivalentna in v odmerku proporcionalna 300 mg tableti.
English: At a therapeutic dose of 300 mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 µg.h/ml (21%), respectively.
Slovenian: Pri terapevtskem odmerku 300 mg enkrat na dan je srednja (CV) Cmax lamivudina v ravnotežnem stanju 2,0 µg/ml (26%), srednja (CV) Cmin lamivudina v ravnotežnem stanju 0,04 µg/ml (34%), in srednja (CV) AUC v 24-urnem odmernem intervalu 8,9 µg.h/ml (21%).
English: The clinical relevance of these findings is not established.
Slovenian: Klinični pomen tega odkritja še ni pojasnjen.
English: Hypromellose (E464) Titanium dioxide (E171), Macrogol,
Slovenian: Filmska obloga tablete: hipromeloza (E464) titanov dioksid (E171) makrogol polisorbat 80
English: Once Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Slovenian: Enkrat na dan HIV-1 RNA v plazmi < 80 kopij/ml: n/N (%)
English: Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg):
Slovenian: Priporočila glede odmerjanja - Odrasli, mladostniki in otroci (ki tehtajo vsaj 25 kg):
English: Do not take Epivir: • if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in Section
Slovenian: • če ste alergični na lamivudin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Adults, adolescents and children who weigh at least 25 kg:
Slovenian: Odrasli, mladostniki in otroci, ki tehtajo vsaj 25 kg:
English: • feeling sick (nausea)
Slovenian: • občutek slabosti (navzea),
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road
Slovenian: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations)
English: 10 mg/kg once daily or
Slovenian: 10 mg/kg enkrat na dan ali
English: 100 mg (10 ml) once daily
Slovenian: 100 mg (10 ml) enkrat na dan
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance.
Slovenian: Zaradi omejene presnove in vezave na plazemske proteine ter skoraj popolnega ledvičnega očistka je verjetnost presnovnih interakcij majhna.
English: What Epivir looks like and the contents of the pack Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 30 tablets.
Slovenian: Zdravilo Epivir 300 mg filmsko obložene tablete je na voljo v belih polietilenskih plastenkah ali pretisnih omotih, ki vsebujejo 30 tablet.
English: Epivir is a type of medicine known as an anti-retroviral.
Slovenian: Zdravilo Epivir je protivirusno zdravilo.
English: 25 mg (2.5 ml) once daily
Slovenian: 25 mg (2,5 ml) enkrat na dan
English: Each film-coated tablet contains 150 mg lamivudine.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg lamivudina.
English: This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Slovenian: Vendar pa, če bolnik nima oslabljenega delovanja ledvic, odmerka ni potrebno prilagoditi (glejte poglavji 4.5 in 4.2).
English: • high doses of co-trimoxazole, an antibiotic
Slovenian: • visoki odmerki antibiotika kotrimoksazola,
English: Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Slovenian: HIV-1 RNA v plazmi < 80 kopij/ml Razlika v tveganju (enkrat na dan-dvakrat na dan)
English: What Epivir contains
Slovenian: Kaj vsebuje zdravilo Epivir
English: Whenever possible in children, an all-tablet regimen should preferably be used.
Slovenian: Če je le mogoče, naj bi pri otrocih uporabljali shemo zdravljenja, ki obsega samo tablete.
English: Do not store Epivir above 30
Slovenian: Zdravilo Epivir shranjujte pri temperaturi do 30 ºC.
English: Talk to your doctor if this applies to you.
Slovenian: Posvetujte se s svojim zdravnikom, če se to nanaša na vas.
English: • irritated or runny nose
Slovenian: • draženje in izcedek iz nosu,
English: People may be more likely to get this condition:
Slovenian: Verjetnost za to motnjo je večja pri bolnikih:
English: If you or your child has a kidney problem, your dose may be altered.
Slovenian: Če imate vi ali vaš otrok težave z ledvicami, vam bodo odmerek morda spremenili.
English: Talk to your doctor if any of these apply to you.
Slovenian: Posvetujte se z zdravnikom, če se karkoli od tega nanaša na vas.
English: What Epivir looks like and the contents of the pack Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets.
Slovenian: Zdravilo Epivir 150 mg filmsko obložene tablete je na voljo v belih polietilenskih plastenkah ali pretisnih omotih, ki vsebujejo 60 tablet.
English: Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided.
Slovenian: Pri zdravljenju pljučnice povzročene s Pneumocystis jirovecii (PCP) in zdravljenju toksoplazmoze se je potrebno izogibati sočasnemu dajanju lamivudina in visokih odmerkov kotrimoksazola.
English: 300 mg (30 ml)
Slovenian: 300 mg (30 ml) ali
English: 150 mg (15 ml) twice daily
Slovenian: 150 mg (15 ml) dvakrat na dan
English: • if you or your child has a kidney problem, your dose may be altered.
Slovenian: • če imate vi ali vaš otrok težave z ledvicami, vam bo zdravnik morda spremenil odmerek.
English: 300 mg once daily or
Slovenian: 300 mg enkrat na dan ali
English: 0.9 mg/kg once daily
Slovenian: 0,9 mg/kg enkrat na dan
English: 60 film-coated tablets Scored tablets
Slovenian: 60 filmsko obloženih tablet tablete z razdelilno zarezo
English: Each ml of oral solution contains 10 mg lamivudine
Slovenian: En ml peroralne raztopine vsebuje 10 mg lamivudina
English: Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4).
Slovenian: Za otroke, ki so starejši od treh mesecev in tehtajo manj kot 14 kg ali za bolnike, ki tablet ne morejo pogoltniti, je zdravilo Epivir na voljo tudi v obliki peroralne raztopine (glejte poglavje 4.4).
English: Lamivudine 8mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Slovenian: Starostna skupina lamivudin odmerjanje 8 mg/kg enkrat na dan, geometrična sredina (95 % IZ)
English: Each film-coated tablet contains 300 mg lamivudine
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg lamivudina
English: 150 mg once daily
Slovenian: 150 mg enkrat na dan
English: Hypromellose (E464), Titanium dioxide (E171), Black iron oxide (E172),
Slovenian: Filmska obloga tablete: hipromeloza (E464) titanov dioksid (E171) črni železov oksid (E172) makrogol polisorbat 80
English: 150 mg (15 ml) once daily
Slovenian: 150 mg (15 ml) enkrat na dan
English: 50 mg (5 ml) once daily
Slovenian: 50 mg (5 ml) enkrat na dan
English: 5 mg/kg once daily
Slovenian: 5 mg/kg enkrat na dan
English: If you have a kidney problem, your dose may be altered.
Slovenian: Če imate težave z ledvicami, se bo vaš odmerek morda spremenil.
English: The usual dose of Epivir is 300 mg a day.
Slovenian: Običajni odmerek je 300 mg tablete enkrat na dan.
English: If you get any of the side effects talk to your doctor.
Slovenian: Če opazite kateregakoli od teh simptomov: se posvetujte z zdravnikom.
English: The following adverse reactions have been reported during therapy for HIV disease with Epivir.
Slovenian: Med zdravljenjem bolezni HIV z zdravilom Epivir so poročali o naslednjih neželenih učinkih.
English: You need to know about important signs and symptoms to look out for while you are taking Epivir.
Slovenian: Medtem ko jemljete zdravilo Epivir, morate biti seznanjeni s pomembnimi znaki in simptomi, na katere morate biti pozorni.
English: 10 mg/kg or
Slovenian: 10 mg/kg ali
English: Common side effects These may affect up to 1 in 10 people:
Slovenian: Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 bolnikov:
English: EU/1/96/015/003 (Bottle) EU/1/96/015/005 (Blister pack)
Slovenian: Epivir 300 mg filmsko obložene tablete EU/1/96/015/003 (Plastenka) EU/1/96/015/005 (Pretisni omot)
English: Do not store above 25°C
Slovenian: Shranjujte pri temperaturi do 25 ºC!
English: Epivir 150 mg tablets lamivudine
Slovenian: Epivir 150 mg tablete lamivudin
English: Treatment with Epivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Slovenian: Če klinični znaki, simptomi ali laboratorijska odstopanja kažejo na možnost pankreatitisa, je potrebno zdravljenje z zdravilom Epivir nemudoma prekiniti.
English: Each ml of oral solution contains 10 mg of lamivudine.
Slovenian: En ml peroralne raztopine vsebuje 10 mg lamivudina.
English: The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Slovenian: Kot učinka, ki sta verjetno klinično pomembna, so odkrili padec števila eritrocitov in nevtrofilcev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 8. avgust 1996
English: Do not store above 30°C
Slovenian: Shranjujte pri temperaturi do 30 ºC!
English: 5 mg/kg twice daily
Slovenian: 5 mg/kg dvakrat na dan
English: 1.6 mg/kg once daily
Slovenian: 1,6 mg/kg enkrat na dan
English: Remove the bottle cap. Keep it safely
Slovenian: Shranite ga na varnem.
English: Consider more frequent monitoring of HIV-1 viral load when Epivir is used with chronically-administered, sorbitol-containing medicines [e.g. Ziagen oral solution].
Slovenian: Če je zdravilo Epivir uporabljano sočasno s kroničnim jemanjem zdravil, ki vsebujejo sorbitol [npr. s peroralno raztopino zdravila Ziagen, je treba pogosteje kontrolirati virusno breme HIV-1.
English: Administration of Epivir tablets is bioequivalent to Epivir oral solution with respect to AUC∞ and Cmax in adults.
Slovenian: Glede na AUC∞ in Cmax pri odraslih je jemanje zdravila Epivir tablet bioekvivalentno jemanju zdravila Epivir peroralna raztopina.
English: Epivir 10 mg/ml oral solution Lamivudine
Slovenian: Epivir 10 mg/ml peroralna raztopina lamivudin
English: This can be taken either as 15 ml (150 mg) twice a day (leaving approximately 12 hours between each dose), or as 30 ml (300 mg) once a day.
Slovenian: Običajni odmerek zdravila Epivir je 30 ml (300 mg) na dan. Odmerek se lahko jemlje kot 15 ml (150 mg) dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali kot 30 ml (300 mg) enkrat na dan.
English: This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4).
Slovenian: Priporočen dnevni odmerek zdravila Epivir je 300 mg. Priporočen dnevni odmerek se lahko daje bodisi v obliki 150 mg (15 ml) odmerka dvakrat na dan, bodisi v obliki 300 mg (30 ml) odmerka enkrat na dan (glejte poglavje 4.4).