natgillin/translations-raw huggingface dataset:
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. 
Pri bolnikih, okuženih z virusom HIV, ki imajo ob uvedbi kombiniranega protiretrovirusnega zdravljenja hudo imunsko pomanjkljivost, lahko nastane vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene.
300 mg once daily or 
300 mg enkrat dnevno ali
As well as the side effects listed below for Lamivudine Teva Pharma B.V., other conditions can develop during combination therapy for HIV. 
Poleg neželenih učinkov zdravila Lamivudine Teva Pharma B.V., ki so navedeni spodaj, se lahko med kombiniranim zdravljenjem okužbe s HIV pojavijo še druge motnje.
Lamivudine 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). 
Za otroke, ki so starejši od treh mesecev in tehtajo manj kot 14 kg, ali za bolnike, ki tablet ne morejo pogoltniti, je zdravilo Lamivudine na voljo tudi v obliki peroralne raztopine (glejte poglavje 4.4).
These may affect up to 1 in 1000 people: 
Pojavijo se lahko pri največ 1 od 1.000 bolnikov:
Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. 
Moteno delovanje mitohondrijev: Dokazano je, da nukleozidni in nukleotidni analogi in vitro in in vivo v različni meri okvarijo mitohondrije.
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction. 
Študije pri bolnikih z oslabljenim delovanjem ledvic kažejo, da okvara ledvic vpliva na izločanje lamivudina.
10 mg/kg once daily or 
10 mg/kg enkrat dnevno ali
3 to 12 years (N=35) 
(n = 35)
Renal impairment: Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance. 
Okvara ledvic: zaradi zmanjšanega očistka so pri bolnikih z zmerno do hudo okvaro ledvic koncentracije lamivudina povečane.
Keep in touch with your doctor, and do not stop taking Lamivudine Teva Pharma B.V. without your doctor's advice. 
Bodite v stiku z zdravnikom in ne prenehajte jemati zdravila Lamivudine Teva Pharma B.V.
• high doses of co-trimoxazole, an antibiotic. 
• visoki odmerki antibiotika kotrimoksazola,
Maintenance dose 
prvi odmerek vzdrževalni odmerek
ARROW PK Substudy Part 1 
FK podštudija ARROW
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance. 
Zaradi omejene presnove in vezave na beljakovine v plazmi ter skoraj popolnega ledvičnega očistka je verjetnost presnovnih interakcij majhna.
Lamivudine Teva Pharma B.V. contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”. 
vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obloženo tableto, kar v bistvu pomeni ‘brez natrija'.
Lamivudine 8 mg/kg OnceDaily Dosing Geometric Mean (95% Cl) 
Lamivudin odmerjanje 8 mg/kg enkrat na dan, geometrična sredina (95% IZ)
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). 
Pediatrična populacija: 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).
There are no data available on the use of lamivudine in children with renal impairment. 
25 mg enkrat dnevno Podatki o uporabi lamivudina pri otrocih z oslabljenim delovanjem ledvic niso na voljo.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). 
Poročali so o primerih osteonekroze, zlasti pri bolnikih, ki imajo splošno znane dejavnike tveganja ali napredovalo bolezen HIV ali ki so bili dalj časa izpostavljeni kombiniranemu protiretrovirusnemu zdravljenju, vendar pogostost ni znana (glejte poglavje 4.4).
The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC∞, Cmax, and tmax. 
Glede na vrednosti AUC∞, Cmax in tmax je 150 mg tableta bioekvivalentna in sorazmerna 300 mg tableti.
Skin and subcutaneous tissue disorders Common: Rash, alopecia. 
Bolezni kože in podkožja Pogosti: izpuščaj, alopecija.
Drug Interactions: Lamivudine Teva Pharma B.V. should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5). 
se ne sme uporabljati z nobenim drugim zdravilom, ki vsebuje lamivudin, in tudi ne z zdravili, ki vsebujejo emtricitabin (glejte poglavje 4.5).
In 60 healthy adult volunteers, lamivudine 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at steady-state to lamivudine 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax. 
po 300 mg enkrat dnevno farmakokinetično ekvivalentno odmerjanju po 150 mg dvakrat dnevno, kar zadeva vrednosti AUC24 in Cmax trifosfata znotraj celice v stanju dinamičnega ravnovesja.
Plasma HIV-1 RNA <80 c/mL Risk difference (once daily-twice daily) 
HIV-1 RNA v plazmi < 80 kopij/ml Razlika v tveganju (enkrat na dan-dvakrat na dan)
Co-administration of lamivudine with food results in a delay of tmax and a lower Cmax (decreased by 47%). 
Posledici sočasnega jemanja lamivudina s hrano sta zakasnitev tmax in zmanjšanje Cmax (zmanjšanje za 47 %), vendar to ne vpliva na obseg absorpcije lamivudina (na podlagi vrednosti AUC).
Opportunistic infections: Patients receiving Lamivudine Teva Pharma B.V. or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases. 
ali katero koli drugo protiretrovirusno zdravljenje, še vedno lahko pojavijo oportunistične okužbe in drugi zapleti, povezani z okužbo z virusom HIV, morajo ostati pod skrbnim kliničnim nadzorom zdravnikov, izkušenih v zdravljenju okužb z virusom HIV.
The likelihood of metabolic interactions of lamivudine with other medicinal products is low due to the small extent of hepatic metabolism (5-10%) and low plasma protein binding. 
Zaradi majhnega (5 do 10 %) obsega jetrne presnove in majhne vezave lamivudina na beljakovine v plazmi je verjetnost presnovnih interakcij z drugimi zdravili majhna.
If Lamivudine Teva Pharma B.V. is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see lamivudine 100 mg SmPC). 
ukine, je treba redno opravljati teste delovanja jeter in preverjati označevalce replikacije virusa HBV, ker lahko ukinitev lamivudina vodi v akutno poslabšanje hepatitisa (glejte povzetek glavnih značilnosti za lamivudin 100 mg).
These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A). 
Sestavljali so jo pretežno asimptomatski bolniki, okuženi z virusom HIV (stadij A po merilih CDC).
150 mg twice daily 
150 mg dvakrat dnevno
Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy. 
Podatki iz kliničnih študij kažejo, da lamivudin v kombinaciji z zidovudinom pri bolnikih, ki se še niso zdravili s protiretrovirusnimi zdravili, zakasni pojav izolatov, odpornih na zidovudin.
If you forget to take Lamivudine Teva Pharma B.V. 
Če ste pozabili vzeti zdravilo Lamivudine Teva Pharma B.V.
Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or HDPE containers containing 30 tablets. 
je na voljo v pretisnih omotih iz aluminija, ki vsebujejo 20, 30, 60, 80, 90, 100 ali 500 tablet, ali vsebnikih za tablete iz polietilena velike gostote, ki vsebujejo 30 tablet.
Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or HDPE containers containing 60 tablets. 
je na voljo v pretisnih omotih iz aluminija, ki vsebujejo 20, 30, 60, 80, 90, 100 ali 500 tablet, ali vsebnikih za tablete iz polietilena velike gostote, ki vsebujejo 60 tablet.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV. 
Ženskam, okuženim z virusom HIV, se dojenje v vsakem primeru odsvetuje zaradi tveganja za prenos virusa HIV na otroka.
When possible, avoid chronic coadministration of Lamivudine Teva Pharma B.V. with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, 
z zdravili, ki vsebujejo sorbitol ali druge osmotsko delujoče poli-alkohole oziroma monosahardine alkohole (npr. ksilitol, manitol, laktitol, maltitol).
NAME OF THE MARKETING AUTHORISATION HOLDER TEVA B.V. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TEVA B.V.
Other medicines and Lamivudine Teva Pharma B.V. 
Druga zdravila in zdravilo Lamivudine Teva Pharma B.V.
Children weighing at least 20 kg and less than 25 kg The usual dose of Lamivudine Teva Pharma B.V. is 225 mg a day. 
Otroci, ki tehtajo vsaj 20 kg in manj kot 25 kg: Običajni odmerek zdravila Lamivudine Teva Pharma B.V.
White opaque HDPE tablet containers with white opaque polyethylene child resistant screw cap with induction seal. 
Vsebniki za tablete iz belega neprosojnega polietilena velike gostote s pokrovčkom na navoj, ki ga otroci ne morejo odpreti, iz belega neprosojnega polietilena in z indukcijskim tesnilom.
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine Teva Pharma B.V. or other medicines you are taking, or an effect of the HIV disease itself. 
Če se zdravite zaradi okužbe s HIV, je včasih težko reči ali je simptom neželeni učinek zdravila Lamivudine Teva Pharma B.V.
Lamivudine Teva Pharma B.V. is used to treat HIV (human immunodeficiency virus) infection in adults and children. 
se uporablja za zdravljenje okužbe z virusom HIV (virus humane imunske pomanjkljivosti) pri odraslih in otrocih.
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Light grey, diamond shaped, biconvex film-coated tablet with approx. 14.5 mm length and 7.0 mm width - engraved with “L 150” and breakline on one side and breakline on the other. 
Svetlo siva, bikonveksna, filmsko obložena tableta v obliki romba, dolga približno 14,5 mm in široka približno 7,0 mm, z vtisnjeno oznako »L 150« in razdelilno zarezo na eni strani ter z razdelilno zarezo na drugi strani.
What Lamivudine Teva Pharma B.V. is and what it is used for What you need to know before you take Lamivudine Teva Pharma B.V. How to take Lamivudine Teva Pharma B.V. 
in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lamivudine Teva Pharma B.V.
This difference in suppression rates between tablets and solutions remained through Week 96 with once daily dosing. 
Tekom 96. tedna je pri režimu odmerjanja enkrat na dan razlika v stopnjah supresije med tabletami in raztopinami ostala nespremenjena.
100 mg once daily 
100 mg enkrat dnevno
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets: 60 ml container of 30 film-coated tablets. 
300 mg filmsko obložene tablete: 60 ml vsebnik za tablete s 30 filmsko obloženimi tabletami.
5 mg/kg once daily 
5 mg/kg enkrat dnevno
150 mg once daily 
150 mg enkrat dnevno
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Lamivudine Teva Pharma B.V. 300 mg film-coated tablets 
150 mg filmsko obložene tablete Lamivudine Teva Pharma B.V.
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets EU/1/09/596/008 20 tablets (blister) EU/1/09/596/009 30 tablets (blister) EU/1/09/596/010 60 tablets (blister) EU/1/09/596/011 90 tablets (blister) EU/1/09/596/012 100 tablets (blister) EU/1/09/596/013 500 tablets (blister) EU/1/09/596/014 30 tablets (bottle) EU/1/09/596/016 80 tablets(blister) 
EU/1/09/596/008 20 tablet (pretisni omot) EU/1/09/596/009 30 tablet (pretisni omot) EU/1/09/596/010 60 tablet (pretisni omot) EU/1/09/596/011 90 tablet (pretisni omot) EU/1/09/596/012 100 tablet (pretisni omot) EU/1/09/596/013 500 tablet (pretisni omot) EU/1/09/596/014 30 tablet (vsebnik)
Paediatric population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving an oral solution of lamivudine as compared to those receiving the tablet formulation. 
študija), so pri otrocih, ki so prejemali lamivudin v obliki peroralne raztopine, poročali o nižjih stopnjah virusne supresije in pogostejši virusni odpornosti, v primerjavi s tistimi, ki so prejemali tablete.
In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen. 
V farmakokinetični študiji (PENTA 15) so štirje virološko obvladani preiskovanci, mlajši od 12 mesecev, prešli s peroralne raztopine abakavirja in lamivudina dvakrat na dan na režim odmerjanja enkrat na dan. Trije preiskovanci so imeli v 48. tednu nezaznavno virusno obremenitev, eden pa je imel HIV-RNA v plazmi 900 kopij/ml.
3.3 mg/kg once daily 
3,3 mg/kg enkrat dnevno
Uncommon: Transient elevations in liver enzymes (AST, ALT). 
Bolezni jeter, žolčnika in žolčevodov Občasni: prehodna povišanja ravni jetrnih encimov (AST, ALT).
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets EU/1/09/596/001 20 tablets (blister) EU/1/09/596/002 30 tablets (blister) EU/1/09/596/003 60 tablets (blister) EU/1/09/596/004 90 tablets (blister) EU/1/09/596/005 100 tablets (blister) EU/1/09/596/006 500 tablets (blister) EU/1/09/596/007 60 tablets (bottle) EU/1/09/596/015 80 tablets (blister) 
EU/1/09/596/001 20 tablet (pretisni omot) EU/1/09/596/002 30 tablet (pretisni omot) EU/1/09/596/003 60 tablet (pretisni omot) EU/1/09/596/004 90 tablet (pretisni omot) EU/1/09/596/005 100 tablet (pretisni omot) EU/1/09/596/006 500 tablet (pretisni omot) EU/1/09/596/007 60 tablet (vsebnik)
What you need to know before you take Lamivudine Teva Pharma B.V. Do not take Lamivudine Teva Pharma B.V. 
Kaj morate vedeti, preden boste vzeli zdravilo Lamivudine Teva Pharma B.V.
5 mg/kg twice daily 
5 mg/kg dvakrat dnevno
Nervous system disorders Common: Headache, insomnia. 
Pogosti: glavobol, nespečnost.
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Grey, diamond shaped, biconvex film-coated tablet with approx. 18.0 mm length and 8.0 mm widthengraved with “L 300” on one side and plain on the other 
Siva, bikonveksna, filmsko obložena tableta v obliki romba, dolga približno 18,0 mm in široka približno 8,0 mm, z vtisnjeno oznako »L 300« na eni strani in brez oznake na drugi strani.
Light grey, diamond shaped, biconvex film-coated tablet - engraved with “L 150” and breakline on one side and breakline on the other. 
in vsebina pakiranja Svetlo siva, bikonveksna, filmsko obložena tableta v obliki romba, z vtisnjeno oznako »L 150« in razdelilno zarezo na eni strani ter z razdelilno zarezo na drugi strani.
50 mg once daily 
50 mg enkrat dnevno
If you get any symptoms of infection while you are taking Lamivudine Teva Pharma B.V.: Tell your doctor immediately. 
Če se vam pojavijo znaki okužbe, medtem ko jemljete zdravilo Lamivudine Teva Pharma B.V.
This can be taken as either one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by your doctor. 
je 300 mg na dan. Odmerek se lahko jemlje v obliki ene 150 mg tablete dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali po posvetu z zdravnikom v obliki dveh 150 mg tablet enkrat na dan.
Twice Daily Plasma HIV-1 RNA <80 c/ml: n/N (%) 
Dvakrat na dan HIV-1 RNA v plazmi < 80 kopij/ml:
Due to similarities, Lamivudine Teva Pharma B.V. should not be administered concomitantly with other cytidine analogues, such as emtricitabine. 
ne sme dajati sočasno z ostalimi analogi citidina, npr. emtricitabinom.
Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 
je, kot del kombiniranega protiretrovirusnega zdravljenja, indicirano za zdravljenje odraslih in otrok, okuženih z virusom humane imunske pomanjkljivosti
Moreover, Lamivudine Teva Pharma B.V. should not be taken with any other medicinal products containing lamivudine (see section 4.4). 
ne sme jemati z ostalimi zdravili, ki vsebujejo lamivudin (glejte poglavje 4.4).
Administration of lamivudine tablets is bioequivalent to lamivudine oral solution with respect to AUC∞ and Cmax in adults. 
Glede na AUC∞ in Cmax pri odraslih je jemanje tablet lamivudina bioekvivalentno jemanju peroralne raztopine lamivudina.
EU/1/09/596/008 EU/1/09/596/009 EU/1/09/596/010 EU/1/09/596/011 EU/1/09/596/012 EU/1/09/596/013 EU/1/09/596/014 EU/1/09/596/016 
EU/1/09/596/012 EU/1/09/596/013 EU/1/09/596/014 EU/1/09/596/016
Lamivudine Teva Pharma B.V. can be used during pregnancy if clinically needed. 
se lahko uporablja med nosečnostjo, če je klinično potrebno.
Once Daily Plasma HIV-1 RNA <80 c/ml: n/N (%) 
Enkrat na dan HIV-1 RNA v plazmi < 80 kopij/ml:
Grey, diamond shaped, biconvex film-coated tablet - engraved with “L 300” on one side and plain on the other 
in vsebina pakiranja Siva, bikonveksna, filmsko obložena tableta v obliki romba, z vtisnjeno oznako »L 300« na eni strani in gladka na drugi.
This can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor. 
je 225 mg na dan. Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) zjutraj in v obliki 150 mg odmerka (ena cela 150 mg tableta) zvečer ali po posvetu z zdravnikom v obliki 225 mg odmerka (ena in pol 150 mg tableta) enkrat na dan.
1.6 mg/kg once daily 
1,6 mg/kg enkrat dnevno
How to take Lamivudine Teva Pharma B.V. 
Kako jemati zdravilo Lamivudine Teva Pharma B.V.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg of lamivudine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 300 mg lamivudina.
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets: 50 ml container of 60 film-coated tablets. 
150 mg filmsko obložene tablete: 50 ml vsebnik za tablete s
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg of lamivudine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg lamivudina.
Dosing recommendations - Children aged at least 3 months and weighing less than 25 kg: Creatinine clearance (ml/min) First dose 
Priporočila glede odmerjanja - Otroci, stari najmanj 3 mesece, ki tehtajo manj kot 25 kg:
0.9 mg/kg once daily 
1,6 mg/kg 0,9 mg/kg enkrat dnevno
This can be given as 75 mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as advised by your doctor. 
je 150 mg na dan. Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali po posvetu z zdravnikom v obliki 150 mg odmerka (ena cela 150 mg tableta) enkrat na dan.
2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17) 
PENTA 13 Od 2 do 12 let
- Keep this leaflet. 
Pretisni omoti
These medicines should not be used with Lamivudine Teva Pharma B.V.: 
Zdravila, ki se ne smejo uporabljati skupaj z zdravilom Lamivudine Teva Pharma B.V.
Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided. 
Pri zdravljenju pljučnice s povzročiteljem Pneumocystis jirovecii in zdravljenju toksoplazmoze se odsvetuje sočasno dajanje lamivudina in velikih odmerkov kotrimoksazola.
White opaque PVC/PVdC - Aluminium blisters Pack sizes of 20, 30, 60, 80, 90, 100 or 500 film-coated tablets 
Pakiranja po 20, 30, 60, 80, 90, 100 ali 500 filmsko obloženih tablet.
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets lamivudine 
150 mg filmsko obložene tablete lamivudin
A 150 mg strength Lamivudine Teva Pharma B.V. tablet is also available for the treatment of children from 3 months of age who weigh less than 25 kg. 
Za zdravljenje otrok, od treh mesecev starosti, ki tehtajo manj kot 25 kg, je na voljo tudi jakost tablete 150 mg zdravila Lamivudine Teva Pharma B.V.
The following adverse reactions have been reported during therapy for HIV disease with lamivudine: 
Med zdravljenjem bolnikov, okuženih z virusom HIV, z lamivudinom, so poročali o naslednjih neželenih učinkih.
Treatment with Lamivudine Teva Pharma B.V. should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur. 
Če klinični znaki, simptomi ali laboratorijska odstopanja kažejo na možnost pankreatitisa, je treba zdravljenje z zdravilom Lamivudine Teva Pharma B.V.
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets lamivudine 
300 mg filmsko obložene tablete lamivudin
How to store Lamivudine Teva Pharma B.V. 
Shranjevanje zdravila Lamivudine Teva Pharma B.V.
Teл. 
Lda
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Lamivudine Teva Pharma B.V. 300mg film-coated tablets 
PODATKI NA PRIMARNI OVOJNINI Vsebnik za tablete - Lamivudine Teva Pharma B.V.
do not stop Lamivudine Teva Pharma B.V. without your doctor's advice, as your hepatitis may come back) 
brez zdravnikovega navodila, kajti hepatitis se lahko ponovi),
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Each film-coated tablet contains 150 mg lamivudine. 
Ena filmsko obložena tableta vsebuje 150 mg lamivudina.
maltitol). 
(HIV).
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Each film-coated tablet contains 300 mg lamivudine. 
Ena filmsko obložena tableta vsebuje 300 mg lamivudina.
Each infusion lasts 10 or 30 minutes, according to the dose. 
Posamezno infundiranje traja 10 ali 30 minut, odvisno od odmerka.
It is given to adults who have received at least one previous treatment for their cancer. 
Daje se odraslim, ki so prejeli vsaj eno predhodno zdravilo za zdravljenje raka.
It is given in four-week treatment cycles, on days 1, 2, 8, 9, 15 and 16 of each cycle. 
Daje se v štiritedenskih ciklih zdravljenja, 1., 2., 8., 9., 15. in 16. dan vsakega cikla.
What measures are being taken to ensure the safe and effective use of Kyprolis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kyprolis?
Other information about Kyprolis 
Druge informacije o zdravilu Kyprolis
The European Medicines Agency decided that Kyprolis' benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Kyprolis večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Kyprolis received a marketing authorisation valid throughout the EU on 19 November 2015. 
Za zdravilo Kyprolis je bilo 19. novembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation