natgillin/translations-raw huggingface dataset:
The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin)) 
Najpogostejši neželeni učinki, o katerih poročajo in so povezani z leflunomidom so: blago zvišanje krvnega tlaka, levkopenija, parestezija, glavobol, omotica, driska, navzea, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu, zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža, tendosinovitis, zvišan CPK,
- A decrease in the levels of phosphate in the blood. 
- zmanjšanje koncentracije fosfata v krvi, - tesnobnost,.
Leflunomide Teva stored in bottles are available in pack sizes of 30 and 100 film-coated tablets. 
Tablete Leflunomid Teva shranjene v plastenkah so na voljo v pakiranjih po 30 in 100 filmsko obloženih tablet.
• Tablet coating: titanium dioxide, polydextrose, hypromellose, triethyl citrate and macrogol 
• Obloga tablete: titanov dioksid, polidekstroza, hipromeloza, trietilcitrat in makrogol 8000.
Before and during treatment with Leflunomide Teva, your doctor will carry out blood tests at regular times. 
Vaš zdravnik vam bo pred in med zdravljenjem z zdravilom Leflunomid Teva v rednih presledkih opravljal preiskave krvi, da bo kontroliral vaše krvne celice in jetra.
If a patient taking Leflunomide Teva develops a peripheral neuropathy, consider discontinuing Leflunomide Teva therapy and performing the drug elimination 
Če bolnik med jemanjem zdravila Leflunomid Teva razvije periferno nevopatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid Teva in o izvajanju postopka za eliminacijo zdravila.
urticaria 
pankreatitis
Not known side effects (frequency cannot be estimated from the available data): - Kidney failure. 
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - ledvična odpoved, - nenormalno zmanjšanje koncentracije sečne kisline v krvi,
The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and 
Deleži odziva po ACR (American College of Rheumatology) so bili v študiji YU203 27,7 % na placebo, 31,9 % na leflunomid 5 mg, 50,5% na leflunomid 10 mg in 54,5% na leflunomid 25 mg/dan.
• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period 
• druga možnost je, da se v obdobju 11 dni uporabi po 50 g aktivnega oglja v prahu 4-krat na dan.
- Other medicines that are broken down by an enzyme called CYP2C9 e.g. phenytoin (an epilepsy treatment), warfarin and phenprocoumon (blood thinners), and tolbutamide (a type 2 diabetes treatment). 
Leflunomid Teva, ki jo telo absorbira, - druga zdravila, ki se presnavljajo z encimom CYP2C9, na primer fenitoin (uporablja se za zdravljenje epilepsije), varfarin ali fenprokumon (uporabljata se za redčenje krvi) ali tolbutamid (uporablja se za zdravljenje sladkorne bolezni tipa 2).
SPECIAL STORAGE CONDITIONS Do not store above 30°C 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
severe infections, including sepsis which may be fatal Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4). 
Tako kot druga zdravila z imunosupresivnim delovanjem lahko tudi leflunomid zveča dovzetnost za okužbe, vključno z oportunističnimi (glejte tudi poglavje 4.4).
• Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate. 
• Jedro tablete: laktoza monohidrat, povidon, krospovidon, vrstaA, predgelirani koruzni škrob, brezvodni koloidni silicijev dioksid, brezvodna laktoza, magnezijev stearat.
Especially if you are taking any of the following: - Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine. 
- katerakoli druga zdravila, ki se uporabljajo za zdravljenje revmatoidnega artritisa, kot so metotreksat in azatioprin (imunosupresiva), klorokin in hidroksiklorokin (antimalarika), zlato
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme 
urtikarija Zelo redki: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom,
It will take 4 to 6 weeks before you feel an improvement in your condition. 
Do opaznega izboljšanja stanja lahko mine 4 - 6 tednov.
Uncommon side effects (may affect up to 1 in 100 people) - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - Mild reduction in blood platelets, which increases the risk of bleeding or bruising. 
Občasni neželeni učinki (prizadanejo lahko največ 1 od 100 ljudi) - zmanjšanje števila rdečih krvnih celic, kar lahko povzroči bledico kože in slabotnost ali zasoplost (anemija)
- Inflammation of the lung (interstitial lung disease), which may be fatal. 
intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
Tell your doctor immediately and stop taking Leflunomide Teva: - If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a - If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema 
- če se počutite oslabeli, če občutite vrtoglavost ali omotičnost ali težko dihate, saj so to lahko znaki resne alergijske reakcije, - če se vam razvijejo kožni izpuščaji ali razjede v ustih, je to lahko znak smrtno nevarnih reakcij (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
In the event that severe, uncontrolled infections occur, it may be necessary to interrupt leflunomide treatment and administer a washout procedure as described below. 
utegneta biti potrebna prekinitev zdravljenja z leflunomidom in postopek izpiranja, kot je opisano spodaj.
What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other. 
Leflunomid Teva 20 mg filmsko obložene tablete so temno rjavkaste, trikotne filmsko obložene tablete, z vgravirano oznako »20« na eni strani in »L« na drugi strani tablete.
Leflunomide Teva tablets 
Jedro tablete:
What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other. 
Leflunomid Teva 10 mg filmsko obložene tablete so bele, okrogle filmsko obložene tablete, z vgravirano oznako »10« na eni strani in »L« na drugi strani.
4.4 Special warnings and precautions for use Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable. 
Sočasna uporaba hepatotoksičnih ali hematotoksičnih imunomodulirajočih antirevmatičnih zdravil (npr. metotreksata) ni priporočljiva.
• Each Leflunomide Teva 10 mg film-coated tablet contains 10 mg of leflunomide. 
• Ena tableta zdravila Leflunomid Teva 10 mg filmsko obložene tablete vsebuje 10 mg leflunomida.
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable. 
Študije s hemodializo in kontinuirano ambulantno peritonealno dializo (CAPD) kažejo, da A771726,
• Each Leflunomide Teva 20 mg film-coated tablet contains 20 mg of leflunomide. 
• Ena tableta zdravila Leflunomid Teva 20 mg filsko obložene tablete vsebuje 20 mg leflunomida.
Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis have been reported in patients treated with leflunomide. 
Zelo redko sta pri bolnikih, zdravljenih z leflunomidom, opisana Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza.
- A cough or breathing problems as these may indicate inflammation of the lung (interstitial 
- kašelj ali oteženo dihanje, ki lahko nakazujeta vnetje pljuč (intersticijska bolezen pljuč), -
Each film-coated tablet contains 20 mg of leflunomide 
Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
- Hedache. 
- srbenje,
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin 
zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji),
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BLISTER PACK 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA/PLASTENKA
Pregnancy must be excluded before start of 
Pred začetkom zdravljenja z leflunomidom je treba izključiti nosečnost.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila Leflunomid Teva, se posvetujte z zdravnikom , s farmacevtom ali z medicinsko sestro.
Each film-coated tablet contains 10 mg of leflunomide 
Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
- Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal. 
- resne poškodbe jeter (kot sta odpoved jeter ali nekroza), ki so lahko usodne.
The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years. 
Farmakokinetiko A771726 po peroralni uporabi leflunomida so raziskali pri 73 pediatričnih bolnikih,
- If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema 
- vnetje trebušne slinavke, ki lahko povzroči hude bolečine v trebuhu ali križu, - hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem), - hude alergijske reakcije,
Tel: +(44) 1977 628500 
United Kingdom Teva UK Limited Tel: +(44) 1977 628500
Absorption 
Porazdelitev
Cases of peripheral neuropathy have been reported in patients receiving Leflunomide Teva. 
Periferna nevropatija Pri bolnikih, ki so jemali zdravilo Leflunomid Teva, so poročali o primerih periferne nevropatije.
In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients. 
V majhni (n = 30) študiji sočasne uporabe leflunomida (10 do 20 mg na dan) in metotreksata (10 do
Leflunomide Teva 20 mg film-coated tablets leflunomide 
Leflunomid Teva 20 mg filmsko obložene tablete leflunomid
For further information on the sample testing please contact the Marketing Authorisation Holder or its 
Za dodatne informacije o testiranju vzorca se obrnite na imetnika dovoljenja za promet z zdravilom ali njegovega lokalnega predstavnika (glejte poglavje 7).
NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 10 mg film-coated tablets 
IME ZDRAVILA Leflunomid Teva 10 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 20 mg film-coated tablets 
IME ZDRAVILA Leflunomid Teva 20 mg filmsko obložene tablete
Blisters: Do not store above 25°C. 
Pretisni omoti: Shranjujte pri temperaturi do 25°C.
Your doctor may recommend a treatment to remove Leflunomide Teva rapidly and sufficiently from your body. 
Zdravnik vam bo morda predlagal zdravljenje z določenimi zdravili, ki hitro in uspešno odstranijo zdravilo Leflunomid Teva iz telesa, ker to lahko zmanjša tveganje za otroka.
- Abnormal decrease in the levels of blood uric acid. 
- ledvična odpoved, - nenormalno zmanjšanje koncentracije sečne kisline v krvi,
- Dizziness. 
izpuščaj,
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20-40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02). 
V tem preskušanju sta polnilni in vzdrževalni odmerek leflunomida temeljila na treh kategorijah telesne mase: < 20 kg, od 20 do 40 kg in > 40 kg.
Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other. 
Temno rjavkasta, trikotna filmsko obložena tableta, z vgravirano oznako »20« na eni strani in »L« na drugi strani tablete.
- If you are male and wish to father a child. As it cannot be excluded that Leflunomide Teva passes into semen, reliable contraception should be used during treatment with Leflunomide Teva. 
Obstaja možnost, da se zdravilo Leflunomid Teva izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid Teva uporabljati zanesljivo kontracepcijo.
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide Teva 
Pred začetkom uporabe zdravila Leflunomid Teva se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro:
Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the 
Tveganje za resne neželene učinke lahko poleg tega poveča tudi prehod z leflunomida na drugo imunomodulirajoče antirevmatično zdravilo brez postopka izpiranja (glejte poglavje 4.4), in to celo dalj časa po prehodu.
Leflunomide Teva 10 mg film-coated tablets leflunomide 
Leflunomid Teva 10 mg filmsko obložene tablete leflunomid
- If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this 
Kaj morate vedeti, preden boste vzeli zdravilo Leflunomid Teva Ne jemljite zdravila Leflunomid Teva - če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo zvišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji, kot je Stevens-Johnsonov sindrom) ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
- Diarrhoea. 
- bolezni krvi,
Drugsales Ltd. 
Teva Italia S.r.l.
Reproductive system and breast disorders marginal (reversible) decreases in sperm concentration, total sperm count and rapid 
mejno (reverzibilno) znižanje koncentracije semenčic, celotnega števila semenčic in hitre progresivne gibljivosti Splošne težave in spremembe na mestu aplikacije Pogosti:
mild allergic reactions severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy 
hude anafilaktične/anafilaktoidne reakcije, vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom
Common side effects (may affect up to 1 in 10 people) - Mild increase in blood pressure. 
Pogosti neželeni učinki (prizadanejo lahko največ 1 od 10 ljudi)
General disorders and administration site conditions anorexia, weight loss (usually insignificant), asthenia 
anoreksija, izguba telesne mase (ponavadi nepomembno), astenija 4.9 Preveliko odmerjanje
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after 
Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid Teva je treba upoštevati dolg razpolovni čas leflunomida.
If after stopping treatment with Leflunomide Teva you plan to become pregnant, you need to ensure that Leflunomide Teva has left your body before trying to become pregnant. 
Teva zanositi, saj se morate preden poskušate zanositi prepričati, da v telesu ni več ostankov zdravila Leflunomid Teva.
In such cases re-exposure to leflunomide is contra-indicated (see 
Ponovna uporaba leflunomida je kontraindicirana (glejte poglavje 4.3).
- Severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). 
• Preobčutljivost za zdravilno učinkovino (posebno s predhodnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo, multiformnim eritemom) ali katerokoli pomožno snov.
Quinoline Yellow Aluminium lake (E104) 
Rumeni železov oksid (E172) Polisorbat (E433) Kinolinsko rumeno barvilo (E104) Indigotin (E132)
Since Leflunomide Teva can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly. 
Prav tako vam bo vaš zdravnik redno meril krvni tlak, saj ga zdravilo Leflunomid Teva lahko zviša.
Pack sizes of 28, 30 and 100 film-coated tablets. 
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 28 filmsko obloženih tablet 30 filmsko obloženih tablet 100 filmsko obloženih tablet
- Tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal. 
- bledico, utrujenost ali podplutbe, ki so lahko znak krvnih bolezni, ki jih povzroči neravnovesje različnih krvnih celic, ki sestavljajo kri, - utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna, - simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj to zdravilo lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna,
Package leaflet: Information for the user 
Zaploditev otroka (priporočila za moške)
Medicinal product subject to medical prescription. 
Rp - Predpisovanje in izdaja zdravila je le na recept.
Respiratory, thoracic and mediastinal disorders interstitial lung disease (including interstitial pneumonitis), which may be fatal diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, 
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
EU/1/11/675/010 100 film-coated tablets 
EU/1/11/675/010 100 filmsko obloženih tablet
Name and address of the manufacturers responsible for batch release TEVA Pharmaceutical Works Private Limited Company 
Ime in naslov izdelovalcev, odgovorneih za sproščanje serije
Pack sizes of 30 and 100 film-coated tablets. 
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 30 filmsko obloženih tablet 100 filmsko obloženih tablet
• Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch 
Laktoza monohidrat Povidon
Immune system disorders severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy 
glavobol, omotica, parestezije, periferna nevropatija
- problems in the nerves of the arms or legs (peripheral neuropathy). 
- blage alergijske reakcije, - povišanje rezultatov nekaterih jetrnih testov, - težave z živci rok ali nog (periferna nevropatija).
Suomi/Finland ratiopharm Oy 
България Тева Фармасютикълс България ЕООД
EU/1/11/675/007 100 film-coated tablets 
EU/1/11/675/007 100 filmsko obloženih tablet
(maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate. 
Brezvodni koloidni silicijev dioksid Brezvodna laktoza Magnezijev stearat
Posology 
SERIJ
Contents of the pack and other information 
Shranjevanje zdravila Leflunomid Teva Vsebina pakiranja in dodatne informacije
After this the dose is 10 mg or 20 mg once daily depending on the severity of the disease. 
Potem 10 mg ali 20 mg zdravila Leflunomid Teva enkrat na dan, odvisno od resnosti obolenja Tablete zdravila Leflunomid Teva pogoltnite celo in z veliko vode.
EU/1/11/675/005 100 film-coated tablets 
EU/1/11/675/005 100 filmsko obloženih tablet
EU/1/11/675/002 100 film-coated tablets 
EU/1/11/675/002 100 filmsko obloženih tablet
4.2 Posology and method of administration The treatment should be initiated and supervised by specialists experienced in the treatment of 
Zdravljenje lahko prične in nadzira le specialist, ki ima izkušnje pri zdravljenju revmatoidnega artritisa.
All patients received folate 1 mg bid. 
Vsi bolniki, ki so dobivali leflunomid, so v preskušanjih III. faze dobivali začetni odmerek 100 mg 3
Tell your doctor immediately if you experience: - Pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood. 
Nemudoma obvestite svojega zdravnika, če opazite: - bledico, utrujenost ali podplutbe, ki so lahko znak krvnih bolezni, ki jih povzroči neravnovesje različnih krvnih celic, ki sestavljajo kri, - utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna, - simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj to zdravilo lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna, - kašelj ali oteženo dihanje, ki lahko nakazujeta vnetje pljuč (intersticijska bolezen pljuč) - nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
Because you may get increased side effects, it is not recommended to take any of these medicines while you are taking Leflunomide Teva. 
Sočasno jemanje kateregakoli od navedenih zdravil z zdravilom Leflunomid Teva ni priporočljivo, ker se lahko pri vas pojavi več neželenih učinkov.
EXPIRY DATE 
Čakalno obdobje
- If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Leflunomide Teva from your body. 
- če že imate zmanjšano število rdečih ali belih krvnih celic (anemija ali levkopeniija), zmanjšano število krvnih ploščic, kar bi lahko povečalo krvavitve ali pojav modric
What you need to know before you take Leflunoamide Teva 
Če ste pozabili vzeti zdravilo Leflunomid Teva
- Abdominal pain. 
Za peroralno uporabo.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
NALEPKA NA PLASTENKI
In general, patients were monitored for about 27 months, during which they took the medicine for about 24 months on average. 
Na splošno so bolnike spremljali 27 mesecev, in v tem času so zdravilo jemali povprečno 24 mesecev.
The doctor may choose lower doses for certain patients. 
Zdravnik se pri določenih bolnikih lahko odloči za manjše odmerke.
Other information about Entresto 
Druge informacije o zdravilu Entresto
What measures are being taken to ensure the safe and effective use of Entresto? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entresto?
In the group treated with Entresto, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril. 
V skupini, zdravljeni z zdravilom Entresto, je 21,8 % (914 od 4 187) bolnikov bodisi umrlo zaradi težav s srcem in obtokom ali so jih sprejeli v bolnišnico zaradi srčnega popuščanja, v primerjavi s 26,5 % (1 117 od 4 212) bolnikov, ki so se zdravili z enalaprilom.
It is not intended to provide practical advice on how to use Entresto. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entresto's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Entresto večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.