natgillin/translations-raw huggingface dataset:
You do not need to take another dose if you were sick more than an hour after taking Emtriva. 
Še enega odmerka vam ni treba vzeti, če je bruhanje nastopilo več kot eno uro po zaužitju zdravila Emtriva.
Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over. 
Zdravilo Emtriva v kombinaciji z drugimi protiretrovirusnimi zdravili je indicirano za zdravljenje odraslih in otrok, starih 4 mesece in več, okuženih z virusom humane imunske pomanjkljivosti-1
Elderly: Emtriva has not been studied in patients over the age of 65. 
Starejši: Zdravila Emtriva niso proučevali pri bolnikih, starejših od 65 let.
The following side effects are common (these can affect up to 10 in every 100 patients): 
Naslednji neželeni učinki so pogosti (pojavijo se lahko pri največ 10 od 100 bolnikov):
Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see sections 4.2, 4.4 and 
Pri vseh bolnikih z očistkom kreatinina < 30 ml/min je potrebno prilagoditi odmerek ali interval odmerjanja (glejte poglavji 4.2, 4.4 in 5.2).
One 200 mg hard capsule every 72 hours 
Ena 200 mg trda kapsula vsakih 72 ur
General disorders and administration site conditions: Common: 
Splošne težave in spremembe na mestu aplikacije: Pogosti:
Hepatic insufficiency 
Jetrna insuficienca
Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with Emtriva. 
Verjetnost, da je ledvična funkcija pri starejših bolnikih zmanjšana, je večja, zato je pri zdravljenju starejših bolnikov z zdravilom
Each mL contains 10 mg of emtricitabine. 
1 ml vsebuje 10 mg emtricitabina.
Method of administration Emtriva 200 mg hard capsules should be taken once daily, orally with or without food. 
Način uporabe Zdravilo Emtriva 200 mg trde kapsule se jemljejo enkrat dnevno, peroralno, s hrano ali brez.
One 200 mg hard capsule every 24 hours 
Ena 200 mg trda kapsula vsakih 24 ur
Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/mL oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/mL oral solution may be administered with or without food. 
Uporaba Emtriva 200 mg trdih kapsul hkrati z zelo mastnim obrokom ali uporaba Emtriva 10 mg/ml peroralne raztopine z malo mastnim ali zelo mastnim obrokom ni imela učinka na sistemsko izpostavljenost (AUC0-∞) emtricitabinu.
In addition to the adverse reactions experienced by adults, anaemia and skin discolouration occurred more frequently in clinical trials involving HIV infected paediatric patients (see section 4.8). 
Poleg neželenih reakcij, ki so jih doživeli odrasli, sta se v kliničnih študijah s pediatričnimi bolniki, okuženimi z virusom HIV, pogosteje pojavili anemija in sprememba obarvanosti kože (glejte poglavje 4.8).
After opening the bottle, do not store above 25°C. 
Po odprtju shranjujte plastenko pri temperaturi do 25 °C.
Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see section 4.4). 
Pri vseh bolnikih z očistkom kreatinina < 30 ml/min je potrebno prilagoditi odmerek ali interval odmerjanja (glejte poglavje 4.4).
Resistance: HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase. 
Rezistenca: Rezistenca virusa HIV-1 na emtricitabin se razvije kot posledica sprememb v kodonu 184
Magnesium stearate (E572) Microcrystalline cellulose (E460) Povidone (E1201) 
Vsebina kapsule krospovidon magnezijev stearat (E572) mikrokristalna celuloza (E460)
Emtriva 10 mg/mL oral solution may be taken with or without food. 
Emtriva 10 mg/ml peroralna raztopina se lahko jemlje s hrano ali brez.
Emtriva hard capsules have a white opaque body with a light blue opaque cap. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink. 
Na vsaki kapsuli je s črnim črnilom na pokrovčku odtisnjeno “200 mg” ter na telesu “GILEAD” in [Gilead logo].
If you are sick (vomit) If it's less than an hour since you took Emtriva, take another capsule. 
Če je manj kot ena ura odkar ste vzeli zdravilo Emtriva, vzemite še eno kapsulo.
Each Emtriva hard capsule contains 200 mg of emtricitabine. 
Vsaka trda kapsula zdravila Emtriva vsebuje 200 mg emtricitabina.
Printing ink containing Black iron oxide (E172) Shellac (E904) 
Vsebina črnila: črn železov oksid (E172), šelak (E904)
Patients receiving emtricitabine 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 HIV associated diseases. 
Pri bolnikih, ki se zdravijo z emtricitabinom ali s katerokoli drugo obliko protiretrovirusne terapije, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule. 
Zaradi te razlike v biološki uporabnosti, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine, zagotavljalo podoben plazemski nivo kot je opazen po uporabi emtricitabina v obliki 200 mg trde kapsule.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4). 
Poročajo o avtoimunskih boleznih (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja
Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2and HBV. 
Emtricitabin je sintetični nukleozidni analog citidina z učinkovanjem, ki je specifično HIV-1, HIV-2
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2). 
Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine (24 ml), zagotavljalo podoben plazemski nivo, kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5.2).
Emtriva has not been studied in patients over 65 years of age. 
Zdravila Emtriva niso proučevali pri bolnikih starejših od 65 let.
Emtriva has not been studied in patients over the age of 65. 
Zdravila Emtriva niso proučevali pri bolnikih, starejših od 65 let.
If you stop taking Emtriva • Don't stop taking Emtriva without talking to your doctor. 
• Ne prenehajte jemati zdravila Emtriva, ne da bi se prej posvetovali s svojim zdravnikom.
Emtriva 200 mg hard capsules 
Emtriva 200 mg trde kapsule
Emtriva 10 mg/mL oral solution should be taken once daily, orally with or without food. 
Zdravilo Emtriva 10 mg/ml perorala raztopina se jemlje enkrat dnevno, peroralno, s hrano ali brez.
In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials involving HIV infected paediatric patients. 
Poleg neželenih reakcij, o katerih so poročali pri odraslih, so se v kliničnih študijah s pediatričnimi bolniki, okuženimi z virusom HIV, pogosteje pojavili anemija (9,5 %) in sprememba obarvanosti kože (31,8 %).
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2). 
Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine, zagotavljalo podoben plazemski nivo kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5.2).
Indigotine (E132) Titanium dioxide (E171) 
Ovojnica kapsule: želatina, indigotin (E132), titanov dioksid (E171)
Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201) 
• Druge sestavine zdravila so: Vsebina kapsule: mikrokristalna celuloza (E460), krospovidon, magnezijev stearat (E572),
Emtriva 200 mg hard capsules Emtricitabine 
Emtriva 200 mg trde kapsule emtricitabin
Emtriva 10 mg/mL oral solution Emtricitabine 
Emtriva 10 mg/ml peroralna raztopina emtricitabin
The cup has lines to indicate each mL of solution. 
Merica ima črtice, ki označujejo mililitre raztopine.
Xylitol (E967) 
povidon (E1201)
Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency. 
Zdravilo Emtriva je pri dojenčkih, starih 4 mesece ali več, otrocih in bolnikih, ki ne morejo pogoltniti trdih kapsul ter bolnikih z ledvično insuficienco na voljo tudi v obliki 10 mg/ml peroralne raztopine.
Therefore, children who weigh at least 33 kg may take either one 200 mg hard capsule daily or the oral solution up to a maximum dose of 240 mg (24 mL), once daily. 
enkrat dnevno vzamejo ali eno 200 mg trdo kapsulo ali maksimalno dozo 240 mg (24 ml) peroralne raztopine.
Viruses resistant to zidovudine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50 = 0.002 µmol/l to 0.08 µmol/l). 
(zidovudin, stavudin, tenofovir, abacavir in didanozin), na vse ne-nukleozidne zaviralce reverzne transkriptaze (NNRTI, non-nucleoside reverse transcriptase inhibitors) in vse PI. Virusi, odporni na zidovudin, didanozin in NNRTI-je so obdržali svojo občutljivost za emtricitabin (IC50 = od 0,002 µmol/l do 0,08 µmol/l).
The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 mL of the oral solution. 
Emtriva 200 mg je podoben nivoju po uporabi 24 ml peroralne raztopine.
Immune system disorders: Common: 
Bolezni imunskega sistema:
Emtriva 10 mg/mL oral solution 
Emtriva 10 mg/ml peroralna raztopina
Capsule contents Crospovidone 
Peroralna raztopina.
Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water 
propilenglikol propilparahidroksibenzoat (E216) natrijev hidroksid natrijev dihidrogenfosfat hidrat oranžno FCF (E110) prečiščena voda ksilitol (E967)
Therapy should be initiated by a physician experienced in the management of HIV infection. 
4.2 Odmerjanje in način uporabe Terapijo mora izvajati zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir and didanosine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all PIs. 
Virusi odporni na emtricitabin, so bili navzkrižno odporni na lamivudin, a so ohranili občutljivost za druge nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors)
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/kg once daily. 
okuženih z virusom HIV, ki so prejemali dva 4-dnevna cikla emtricitabina v obliki peroralne raztopine, od prvega tedna do 3 mesecev starosti z odmerkom 3 mg/kg enkrat dnevno.
This medicine contains 36 mg of sodium (main component of cooking/table salt) per 24 mL dose.This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult. 
To zdravilo vsebuje 36 mg natrija (glavna sestavina kuhinjske/namizne soli) na odmerek 24 ml.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (see sections 4.2 and 5.2). 
Zato je potrebno pozorno nadzorovati klinični odziv na zdravljenje in ledvično funkcijo pri bolnikih, ki se zdravijo z emtricitabinom s podaljšanimi intervali odmerjanja
Tabulated summary of adverse reactions 
Povzetek neželenih reakcij, prikazan v preglednici
Please refer to the package leaflets of the other antiretrovirals for guidance on how to take those medicines. 
Prosimo, preberite si navodila za uporabo tudi drugih protiretrovirusnih zdravil.
Metabolism and nutrition disorders: Common: 
alergijska reakcija Presnovne in prehranske motnje:
• Do not breast-feed if you are taking Emtriva. 
• Če jemljete zdravilo Emtriva, ne dojite.
Contact your doctor again before you restart taking Emtriva capsules. 
Preden začnete ponovno jemati kapsule Emtriva, se posvetujte z zdravnikom.
allergic reaction 
Opozorila in previdnostni ukrepi
Each mL of Emtriva oral solution contains 10 mg of emtricitabine. 
1 ml Emtriva peroralne raztopine vsebuje 10 mg emtricitabina.
ANNEX III LABELLING AND PACKAGE LEAFLET 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
How much 10 mg/mL solution to take (mL) 
Dnevno Telesna masa (kg) Odmerek emtricitabina (mg) Koliko 10 mg/ml peroralne raztopine je treba vzeti (ml)
Contact your doctor again before you restart taking Emtriva oral solution. 
Preden začnete ponovno jemati peroralno raztopino Emtriva, se posvetujte z zdravnikom.
170 mL oral solution. 
FARMACEVTSKA OBLIKA IN VSEBINA 170 ml, peroralna raztopina.
There is a separate Package Leaflet for Emtriva 10 mg/mL oral solution. 
Za uporabo peroralne raztopine Emtriva 10 mg/ml je na voljo posebno navodilo za uporabo.
insomnia, abnormal dreams Nervous system disorders: Very common: 
anemija2 Bolezni imunskega sistema:
Emtriva may cause dizziness. 
Emtriva potrebna previdnost
If you have difficulty in swallowing the capsules, tell your doctor. 
Obvestite zdravnika, če imate težave s požiranjem kapsul.
Package leaflet: Information for the user Emtriva 200 mg hard capsules 
Navodilo za uporabo Emtriva 200 mg trde kapsule emtricitabin
Gilead Sciences Ireland UC 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gilead Sciences Ireland UC
London, 24 April 2008 Doc. 
London, 24. april 2008 Sklic na dok.
International non-proprietary name (INN): clofarabine 
Mednarodno nelastniško ime (INN): klofarabin
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF A CHANGE TO THE MARKETING AUTHORISATION for EVOLTRA 
VPRAŠANJA IN ODGOVORI V ZVEZI S UMIKOM SPREMEMBE DOVOLJENJA ZA PROMET z zdravilom EVOLTRA
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding. 
Potem, ko je CHMP ocenil odgovore družbe na seznam vprašanj, je še vedno ostalo nerešenih nekaj pomembnih vprašanj.
Evoltra was designated as an orphan medicine for this condition on 8 May 2003. 
Zdravilo Evoltra je bilo dne 8. maja 2003 določeno kot zdravilo sirota za to bolezen.
On 18 March 2008, Bioenvision Ltd, a wholly owned subsidiary of Genzyme Corporation, officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Evoltra. 
Bioenvision Ltd, podružnica v popolni lasti družbe Genzyme Corporation, je dne 18. marca 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Evoltra.
It belongs to the group of anti-cancer medicines called ‘antimetabolites'. 
Spada v skupino zdravil proti raku, ki jim pravimo „antimetaboliti“.
The study did not compare Evoltra with any other treatment. 
V študiji zdravila Evoltra niso primerjali z nobenim drugim zdravljenjem.
It is used when the disease has not responded to, or has come back (relapsed), after at least two other treatments, and when no other treatment is expected to work. 
Uporablja se, kadar se bolezen ne odzove na zdravljenje ali se ponovi po vsaj dveh drugih zdravljenjih in kadar se ne pričakuje učinkovitost nobene druge oblike zdravljenja.
This stops the cells making new DNA and slows down the growth of tumour cells. 
Zato celice prenehajo izdelovati novo DNK, rast tumorskih celic pa se upočasni.
The change concerned an extension of indication to add the treatment of acute myeloid leukaemia in elderly patients. 
Sprememba se je nanašala na razširitev indikacije za zdravljenje akutne mieloidne levkemije pri starejših bolnikih.
There were also some concerns over the medicine's side effects affecting the kidneys. 
Nekaj zadržkov je bilo tudi zaradi stranskih učinkov zdravila na ledvica.
There are no consequences on the use of Evoltra in the authorised indication, for which the balance of benefits and risks remains unchanged. 
Umik nima nobenih posledic za uporabo zdravila Evoltra za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
Clofarabine is an analogue of adenine, which is part of the DNA, the fundamental genetic material of cells. 
Klofarabin je analog adenina, ki je del DNK, osnovnega genetskega materiala celic.
The company presented results from one main study involving 66 patients aged 65 years or older with AML, who had not been treated before and were considered to be unsuitable for intensive chemotherapy. 
Družba je predstavila izide ene glavne študije, v katero je bilo vključenih 66 bolnikov, starih 65 let ali več, z AML, ki pred tem niso bili zdravljeni in pri katerih se je menilo, da intenzivna kemoterapija ne bi bila primerna.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Evoltra could not have been approved for the treatment of the treatment of AML in elderly patients. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel CHMP zadržke in bil začasnega mnenja, da zdravila Evoltra ni mogoče odobriti za zdravljenje AML pri starejših bolnikih.
The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels). 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila dosežena remisija (očistek levkemije iz kostnega mozga in popolno ali delno povečanje števila krvnih celic na normalne ravni).
It was to be used in patients who are not suitable for intensive chemotherapy, because they have certain genetic abnormalities in their myeloid cells, ‘secondary' AML (AML following a previous blood disorder) or another disease in addition to AML, or because they are 70 years of age or older. 
Uporabljalo naj bi se pri bolnikih, pri katerih intenzivna kemoterapija ni primerna zaradi določenih genetskih nenormalnosti mieloidnih celic, „drugotne“ AML (AML, ki sledi predhodni krvni motnji) ali druge bolezni, ki se pojavi hkrati z AML, oziroma ker so stari sedemdeset let ali več.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Evoltra? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Evoltra?
What is Evoltra? 
Kaj je zdravilo Evoltra?
In the body, clofarabine takes the place of adenine, and interferes with the enzymes involved in making genetic material. 
V telesu klofarabin prevzame mesto adenina in ovira encime, ki sodelujejo pri izgradnji genetskega materiala.
The Committee was concerned that the main study included a number of patients who could have been suitable for intensive chemotherapy and this could have made the effectiveness of Evoltra look more promising. 
Odbor je izrazil zaskrbljenost, da je glavna študija vključevala številne bolnike, pri katerih bi lahko bilo primerno zdravljenje z intenzivno kemoterapijo, pri čemer bi bila učinkovitost zdravila Evoltra obetavnejša.
It contains the active substance clofarabine. 
Vsebuje zdravilno učinkovino klofarabin.
The application was at day 90 when the company withdrew. 
Družba je vlogo umaknila na 90. dan postopka.
The company informed the CHMP that this withdrawal has no consequences for patients enrolled in clinical trials or compassionate use programmes with Evoltra. 
Družba je obvestila CHMP, da umik nima posledic za bolnike, ki so vključeni v klinična preskušanja ali programe sočutne uporabe za zdravilo Evoltra.
The CHMP was concerned that the main study was not sufficient to establish the benefit of Evoltra in the treatment of AML in elderly patients who were unsuitable for intensive chemotherapy, and that the results of a study comparing Evoltra with standard treatment would be necessary to determine the medicine's effectiveness. 
CHMP je imel zadržke, da glavna študija ni zadovoljivo dokazala koristnih učinkov zdravila Evoltra za zdravljenje AML pri starejših bolnikih, pri katerih izvajanje intenzivne kemoterapije ne bi bilo primerno, ter da bi bili za ugotovitev učinkovitosti zdravila potrebni rezultati študije, s katero bi primerjali učinke zdravila Evoltra z učinki pri standardnem zdravljenju.
What was Evoltra expected to be used for? 
Za kaj naj bi se zdravilo Evoltra uporabljalo?
In the new indication, Evoltra was also expected to be used to treat patients aged over 65 years who have acute myeloid leukaemia (AML, cancer of the myeloid cells, a type of immature white blood cell). 
V novi indikaciji naj bi se zdravilo Evoltra uporabljalo tudi pri bolnikih, starih 65 let ali več, z akutno mieloidno levkemijo (AML, rak mieloidnih celic, vrsta nezrelih belih krvnih celic).
How is Evoltra expected to work? 
Kako naj bi zdravilo Evoltra delovalo?
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Evoltra had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je CHMP v času umika menil, da koristi zdravila Evoltra niso bile zadostno dokazane in ne odtehtajo znanih tveganj.
Evoltra is already used to treat children with acute lymphoblastic leukaemia (ALL, cancer of the lymphocytes, a type of white blood cell). 
Zdravilo Evoltra se že uporablja za zdravljenje otrok z akutno limfoblastno levkemijo (ALL, rakom limfocitov, vrsta belih krvnih celic).
Evoltra is a concentrate that is made up into a solution for infusion (drip into a vein). 
Zdravilo Evoltra je koncentrat za pripravo raztopine za infundiranje (dajanje v veno).
What is happening for Evoltra for treatment of ALL in children? 
Kaj to pomeni za zdravilo Evoltra, indicirano za zdravljenje ALL pri otrocih?
The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells). 
Zdravilna učinkovina zdravila Evoltra, klofarabin, je citotoksična (zdravilo, ki ubija deleče se celice, kot so rakaste celice).
Within 3 months of Commission Decision 
V 3 mesecih po odločbi Komisije.
This 5 years retrospective (new users) study will also compare the relative risk between dexamfetamine and other stimulants in the patient population. 
Ta petletna retrospektivna (novi uporabniki) študija bo primerjala tudi relativno tveganje pri deksamfetaminu in drugih stimulantih pri populaciji bolnikov.