natgillin/translations-raw huggingface dataset:
Temomedac 5 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake, yellow iron oxide (E 172) Temomedac 20 mg hard capsules: gelatine, titanium dioxide (E 171), shellac, propylene glycol, sunset yellow FCF aluminium Lake (E 110). 
Temomedac 5 mg tvrdé kapsuly: želatína, oxid titaničitý (E 171), šelak, propylénglykol, hlinitý lak indigokarmínu (E 132), žltý oxid železitý (E 172) Temomedac 20 mg tvrdé kapsuly: želatína, oxid titaničitý (E 171), šelak, propylénglykol, hlinitý lak oranžovej žlti (E 110)
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy. 
9/l), 12 % vs. 5 %, a trombocytopénie 4. stupňa (< 20 x 10
Temomedac 5 mg hard capsules: Each capsule contains 5 mg temozolomide. 
Temomedac 5 mg tvrdé kapsuly: Každá kapsula obsahuje 5 mg temozolomidu.
Temomedac 20 mg hard capsules: Each capsule contains 20 mg temozolomide. 
Temomedac 20 mg tvrdé kapsuly: Každá kapsula obsahuje 20 mg temozolomidu.
- The active substance is temozolomide. 
• Liečivo je temozolomid.
≥ 0.5 and < 1.5 x 109/l < 0.5 x 109/l 
Absolútny počet neutrofilov ≥ 0,5 a < 1,5 x 10
Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide. 
Temomedac 140 mg tvrdé kapsuly: Každá kapsula obsahuje 140 mg temozolomidu.
INFORMATION IN BRAILLE Temomedac 180 mg 
INFORMÁCIE V BRAILLOVOM PÍSME Temomedac 180 mg
Temomedac is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). 
Dospelí pacienti s novodiagnostikovaným multiformným glioblastómom Temomedac sa podáva v kombinácii s fokálnou rádioterapiou (súbežná fáza) nasledovanou až do 6 cyklov monoterapie temozolomidom (TMZ) (fáza monoterapie).
Skin and subcutaneous tissue disorders Very common: 
Poruchy kože a podkožného tkaniva Veľmi časté:
Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide. 
Temomedac 180 mg tvrdé kapsuly: Každá kapsula obsahuje 180 mg temozolomidu.
INFORMATION IN BRAILLE Temomedac 100 mg 
INFORMÁCIE V BRAILLOVOM PÍSME Temomedac 100 mg
Posology 
ŠKATUĽKA
NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 5 mg tvrdé kapsuly temozolomid
NAME OF THE MEDICINAL PRODUCT Temomedac 250 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 250 mg tvrdé kapsuly temozolomid
Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide. 
Temomedac 100 mg tvrdé kapsuly: Každá kapsula obsahuje 100 mg temozolomidu.
NAME OF THE MEDICINAL PRODUCT Temomedac 140 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 140 mg tvrdé kapsuly temozolomid
NAME OF THE MEDICINAL PRODUCT Temomedac 20 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 20 mg tvrdé kapsuly temozolomid
Each hard capsule contains 250 mg temozolomide. 
LIEČIVO Každá tvrdá kapsula obsahuje 250 mg temozolomidu.
Each hard capsule contains 5 mg temozolomide. 
Každá tvrdá kapsula obsahuje 5 mg temozolomidu (temozolomidum).
a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting). 
Súbežná liečba s TMZ môže pokračovať, keď sú splnené všetky nasledovné podmienky: absolútny počet neutrofilov ≥ 1,5 x 10
Each hard capsule contains 140 mg temozolomide. 
Každá tvrdá kapsula obsahuje 140 mg temozolomidu (temozolomidum).
Each hard capsule contains 20 mg temozolomide. 
Každá tvrdá kapsula obsahuje 20 mg temozolomidu (temozolomidum).
NAME OF THE MEDICINAL PRODUCT Temomedac 180 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 180 mg tvrdé kapsuly temozolomid
6.1 List of excipients 
FARMACEUTICKÉ INFORMÁCIE 6.1 Zoznam pomocných látok
Dose during Cycles 2 - 6 in absence of toxicity 
- 6. cyklu, ak sa neobjavila toxicita Tabuľka 3.
NAME OF THE MEDICINAL PRODUCT Temomedac 100 mg hard capsules temozolomide 
NÁZOV LIEKU Temomedac 100 mg tvrdé kapsuly temozolomid
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 250 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 250 mg tvrdé kapsuly temozolomid
Each hard capsule contains 180 mg temozolomide. 
Každá tvrdá kapsula obsahuje 180 mg temozolomidu (temozolomidum).
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, 
• absolútny počet neutrofilov (Absolute Neutrophil Count - ANC) ≥ 1,5 x 10
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 20 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 20 mg tvrdé kapsuly temozolomid
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 5 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 5 mg tvrdé kapsuly temozolomid
Each hard capsule contains 100 mg temozolomide. 
Každá tvrdá kapsula obsahuje 100 mg temozolomidu (temozolomidum).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 140 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 140 mg tvrdé kapsuly temozolomid
This was followed by monotherapy TMZ (150 - 200 mg/m²) on Days 1 - 5 of every 28 day cycle for up to 6 cycles, starting 4 weeks after the end of RT. 
Potom nasledovala monoterapia TMZ (150 - 200 mg/m²) 1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 180 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 180 mg tvrdé kapsuly temozolomid
Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty), - uncontrolled bleeding, - seizures (convulsions), - fever, - chills, - severe headache that does not go away. 
• závažná alergická reakcia (reakcia z precitlivenosti) (žihľavka, sipot alebo iné ťažkosti s dýchaním),
See package leaflet for further information. 
• Túto písomnú informáciu si uschovajte.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 100 mg hard capsules temozolomide 
NÁZOV LIEKU A CESTA PODANIA Temomedac 100 mg tvrdé kapsuly temozolomid
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy. 
Liečba trvala až 6 cyklov a začínalo sa s ňou 4 týždne po ukončení RT. Pacienti v kontrolnom ramene dostávali len RT. Počas RT a aj kombinovanej liečby TMZ sa vyžadovala profylaxia proti pneumónii spôsobenej Pneumocystis jirovecii (PCP).
Further information on Binocrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Nadaljnje informacije o zdravilu Binocrit so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This means that Binocrit is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
Binocrit received a marketing authorisation valid throughout the EU on 28 August 2007. 
Za zdravilo Binocrit je bilo 28. avgusta 2007 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Binocrit? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Binocrit?
For patients with kidney failure, myelodysplastic syndromes or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children). 
Pri bolnikih z odpovedjo ledvic, mielodisplastičnim sindromom ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
When Binocrit is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed. 
Kadar se zdravilo Binocrit uporablja za avtologno transfuzijo krvi, je treba upoštevati omejitve, ki so običajno povezane s to vrsto transfuzije.
An overview of Binocrit and why it is authorised in the EU 
Pregled zdravila Binocrit in zakaj je odobreno v EU
As for all medicines, data on the use of Binocrit are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Binocrit stalno spremljajo.
Side effects reported with Binocrit are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Binocrit, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Binocrit (which may affect more than 1 in 10 people) are nausea (feeling sick),diarrhoea, vomiting, fever and headache. 
Najpogostejši neželeni učinki zdravila Binocrit (ki se lahko pojavijo pri več kot 1 bolniku od 10) so navzeja (slabost), driska, bruhanje, povišana telesna temperatura in glavobol.
Other information about Binocrit 
Druge informacije o zdravilu Binocrit
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Binocrit have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Binocrit upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood; 
Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih lahko pride do zapletov pri transfuziji krvi, če pred kirurškim posegom ne darujejo lastne krvi, pričakovane izgube med posegom pa znašajo od 900 do 1 800 ml;
Why is Binocrit authorised in the EU? 
Zakaj je bilo zdravilo Binocrit odobreno v EU?
Binocrit is a medicine used for the following: 
Binocrit je zdravilo, ki se uporablja v naslednjih primerih:
What benefits of Binocrit have been shown in studies? 
Kakšne koristi zdravila Binocrit so se pokazale v študijah?
For more information about using Binocrit, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Binocrit glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions; 
• za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in zmanjšanje potrebe po transfuziji krvi;
The dose, the frequency of injection and how long it is used for also depend on why Binocrit is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working. 
Odmerek, pogostost injiciranja in trajanje uporabe zdravila Binocrit so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
What are the risks associated with Binocrit? 
Kakšna tveganja so povezana z zdravilom Binocrit?
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; 
• za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim upadanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
What is Binocrit and what is it used for? 
Kaj je zdravilo Binocrit in za kaj se uporablja?
In these cases, epoetin alfa is used to increase red blood cell counts. 
V teh primerih se za povečanje števila rdečih krvnih celic uporablja učinkovina epoetin alfa.
Because Binocrit is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Binocrit. 
Ker je zdravilo Binocrit podobno biološko zdravilo, študij o učinkovitosti in varnosti učinkovine epoetin alfa, ki so bile že izvedene za zdravilo Eprex/Erypo, za zdravilo Binocrit ni treba ponavljati.
The active substance in Binocrit, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. 
Učinkovina v zdravilu Binocrit, epoetin alfa, je kopija hormona eritropoetina in deluje popolnoma enako kot naravni hormon pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu.
Binocrit contains the active substance epoetin alfa and is a ‘biosimilar medicine'. 
Zdravilo Binocrit vsebuje učinkovino epoetin alfa in je „podobno biološko zdravilo“.
Binocrit is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin. 
Zdravilo Binocrit se uporablja pri bolnikih, pri katerih obstaja majhno do srednje tveganje za pojav akutne mieloične levkemije in ki imajo nizke ravni naravnega hormona eritropoetina.
The reference medicine for Binocrit is Eprex/Erypo. 
Referenčno zdravilo za zdravilo Binocrit je zdravilo Eprex/Erypo.
All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Binocrit or remained on Eprex/Erypo. 
Vsem bolnikom so zdravilo Eprex/Erypo najmanj osem tednov injicirali v veno, preden so bodisi začeli prejemati zdravilo Binocrit bodisi so še naprej jemali zdravilo Eprex/Erypo.
Binocrit can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Binocrit is used for. 
Predpisovanje in izdaja zdravila Binocrit je le na recept, zdravljenje z njim pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z bolezni, za katere se to zdravilo uporablja.
Binocrit is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated. 
Zdravilo Binocrit je na voljo v napolnjenih injekcijskih brizgah različnih jakosti in se daje z injiciranjem v veno ali podkožje, kar je odvisno od bolezenskega stanja bolnika, ki se zdravi.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Binocrit has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Binocrit po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Eprex/Erypo in da se po telesu enako prenaša.
Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Binocrit outweighs the identified risk and it can be authorised. 
Agencija je zato menila, da koristi zdravila Binocrit enako kot pri zdravilu Eprex/Erypo odtehtajo znana tveganja in da se zdravilo lahko odobri.
How is Binocrit used? 
Kako se zdravilo Binocrit uporablja?
For the full list of side effects of Binocrit, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Binocrit, glejte navodilo za uporabo.
Patients switching to Binocrit maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo. 
Bolniki, ki so prešli na jemanje zdravila Binocrit, so ohranili enako raven hemoglobina v krvi kot bolniki, ki so nadaljevali zdravljenje z zdravilom Eprex/Erypo.
Laboratory studies comparing Binocrit with the reference medicine Eprex/Erypo have shown that the active substance in Binocrit is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Binocrit primerjali z referenčnim zdravilom Eprex/Erypo, so pokazale, da je učinkovina v zdravilu Binocrit po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Eprex/Erypo.
Studies have also shown that giving Binocrit produces similar levels of the active substance in the body to giving Eprex/Erypo. 
Študije so pokazale tudi, da zdravilo Binocrit vzpostavi podobne ravni učinkovine v telesu kot zdravilo Eprex/Erypo.
In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy. 
Poleg tega so študije pokazale, da so učinki tega zdravila pri zviševanju in ohranjanju ravni krvnih celic pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, enakovredni učinkom zdravila Eprex/Erypo.
How does Binocrit work? 
Kako zdravilo Binocrit deluje?
Binocrit must not be used in the following groups: 
Zdravilo se ne sme uporabljati pri naslednjih skupinah bolnikov:
A further study showed that Binocrit was safe and effective when given under the skin in 416 patients with chronic kidney failure. 
V dodatni študiji so pri 416 bolnikih s kronično odpovedjo ledvic dokazali, da je zdravilo Binocrit pri injiciranju v podkožje varno in učinkovito.
Binocrit, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems. 
V eni glavni študiji, ki je vključevala 479 bolnikov z anemijo, povezano z obolenjem ledvic, so zdravilo Binocrit, injicirano v veno, primerjali z referenčnim zdravilom.
In addition, Binocrit was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies. 
Poleg tega so v več študijah dokazali, da je zdravilo Binocrit pri zviševanju in ohranjanju števila rdečih krvnih celic enako učinkovito kot zdravilo Eprex/Erypo.
Another study showed that Binocrit injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy. 
Druga študija pri 114 bolnikih z rakavimi obolenji, ki so prejemali kemoterapijo, je pokazala, da je zdravilo Binocrit, injicirano v podkožje, enako učinkovito za ohranjanje ravni hemoglobina v krvi kot zdravilo Eprex/Erypo.
You need to keep taking it every day to stop your illness getting worse. 
Morate ga jemati vsak dan, da se vaša bolezen ne bo slabšala.
Repeat steps 3 to 7 in the same way until you have taken your whole dose. 
št. od 3 do 7 ponavljajte na enak način, dokler ne vzamete vašega celotnega odmerka.
If you notice any of these symptoms: 
Če opazite kateregakoli od teh simptomov:
These differences were observed in each different age group studied. 
Te razlike so bile opažene v vsaki preiskovani starostni skupini.
The dose should therefore be adjusted (see tables). 
Odmerek je torej potrebno prilagoditi (glejte tabele).
So it is very important to talk to your doctor about any changes in your health. 
Zato je zelo pomembno, da se z zdravnikom pogovorite o vseh spremembah, ki jih opazite glede vašega zdravja.
Stay in regular contact with your doctor 
Bodite v rednem stiku z zdravnikom
Sucrose may be harmful to the teeth. 
Saharoza ima lahko škodljiv učinek na zobe.
Pancreatitis: Cases of pancreatitis have occurred rarely. 
Pankreatitis: Primeri pankreatitisa so bili redki.
For example, if your dose is 15 ml, you need to take one and a half syringe-fulls of medicine. 
Na primer če je vaš odmerek 15 ml, morate vzeti eno in pol napolnjeno brizgo z zdravilom.
• if you are seriously overweight (especially if you are a woman) 
• če imate prekomerno telesno težo (še posebej, če ste ženska),
This is consistent with the lower rates of antiviral suppression observed in these patients. 
To je skladno z nižjimi stopnjami protivirusne supresije, ki so jo opazili pri teh bolnikih.
It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2). 
Treba je upoštevati, da so podatki o režimu odmerjanja enkrat na dan za to populacijo omejeni (glejte poglavje 4.4, 5.1 in 5.2).
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. 
VIIV HIV HEALTHCARE, UNIPESSOAL, LDA
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). 
Pogostnost je definirana z izrazi zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
Instructions for use are included in the pack. 
Navodila za uporabo so priložena v škatli.
• if they are also taking anti-inflammatory medicines called corticosteroids 
• ki jemljejo tudi protivnetna zdravila imenovana kortikosteroidi,
Turn the bottle upside down. 
Obrnite zgornjo stran plastenke navzdol.
This medicine has been prescribed for you or for your child. Do not pass it on to others. 
Zdravilo je bilo predpisano vam ali vašemu otroku in ga ne smete dajati drugim.
Absorption differences have been observed between adult and paediatric populations (see Special populations). 
Pri odraslih in pediatrični populaciji je bila opažena razlika v absorpciji (glejte Posebne populacije).
Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour. 
Po peroralnem dajanju je srednji čas (tmax) do maksimalnih serumskih koncentracij (Cmax) približno ena uro.
This conclusion is based on the physiochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately. 
Ta zaključek temelji na fizikalno-kemijskih in farmakokinetičnih podatkih na predpostavki, da bolnik zdrobi in prenese 100 % tablete ter jo takoj zaužije.
Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. 
Zdravilo Epivir ne pozdravi popolnoma okužbe z virusom HIV, vendar zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
The observed half-life of elimination is 5 to 7 hours. 
Opazovan eliminacijski razpolovni čas lamivudina znaša 5 do 7 ur.
Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany 
Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Nemčija
CD4 cells are a type of white blood cells that are important in helping your body to fight infection. 
Celice CD4 so vrsta belih krvnih celic, ki opravljajo pomembno vlogo v boju z okužbo.
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans. 
Rezultati dolgoročnih raziskav karcinogenosti lamivudina pri podganah in miših niso pokazali karcinogenega potenciala, ki bi bil pomemben za človeka.
• an increase in the level of liver enzymes. 
• povečane vrednosti jetrnih encimov.
Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, da bi nadoknadili izpuščeni odmerek.
mannitol, lactitol or maltitol), if taken regularly 
manitol, laktitol, maltitol), če se jemljejo redno,
The tablets also contain the following other ingredients: 
Tablete vsebujejo tudi naslednje pomožne snovi:
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Epivir. 
Ne pozabite povedati zdravniku ali farmacevtu, če boste začeli jemati novo zdravilo, medtem ko jemljete zdravilo Epivir.
The frequency of which is unknown (see section 4.4). 
Pogostnost tega ni znana (glejte poglavje 4.4).
If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. 
Če režim odmerjanja dvakrat na dan ni izvedljiv, se lahko razmisli o režimu odmerjanja enkrat na dan (10 mg/kg/dan).
3 to 12 years (N=35) 
Od 3 do 12 let (n = 35)