natgillin/translations-raw huggingface dataset:
• For psoriatic arthritis: 20 mg Arava once daily. 
• za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Arava enkrat na dan.
It is not recommended to drink alcohol during treatment with Arava. 
Med zdravljenjem z zdravilom Arava ni priporočljivo pitje alkohola.
Arava 100 mg film-coated tablets are white to almost white and round. 
Arava 100 mg filmsko obložene tablete so bele do skoraj bele in okrogle oblike.
Cases of peripheral neuropathy have been reported in patients receiving Arava. 
Pri bolnikih, ki so jemali zdravilo Arava, so poročali o primerih periferne nevropatije.
Arava 10 mg film-coated tablets are white to almost white and round. 
Arava 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike.
marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility 
mejno (reverzibilno) znižanje koncentracije semenčic, celotnega števila semenčic in hitre progresivne gibljivosti Splošne težave in spremembe na mestu aplikacije Pogosti:
Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate 
Pomožne snovi z znanim učinkom Ena tableta vsebuje 138,42 mg laktoze monohidrat.
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Arava which is absorbed by the body. 
- indometacin, ketoprofen za bolečino ali vnetje, - furosemid za bolezni srca (diuretik, tableta za odvajanje vode), - zidovudin za HIV okužbe, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (zvišane vrednosti holesterola), - sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis, - zdravilo imenovano holestiramin (uporablja se za zniževanje zvišanega holesterola) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Arava, ki jo telo absorbira.
Povidone (E1201) Crospovidone (E1202) Talc (E553b) 
Krospovidon (E1202) Smukec (553b)
severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis Metabolism and nutrition disorders Common: 
hude anafilaktične/anafilaktoidne reakcije, vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom Presnovne in prehranske motnje Pogosti:
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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 Arava, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders 
parestezije, glavobol, omotica, periferna nevtropatija
Tell your doctor immediately and stop taking Arava: - if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, - 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 multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 
Nemudoma obvestite svojega zdravnika in prenehajte jemati zdravilo Arava: - če občutite slabost, 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, neželena reakcija z eozinofilijo in sistemskimi simptomi [sindrom DRESS]), glejte poglavje 2.
cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) 
kožni eritematozni lupus, postulozna psoriaza ali njeno poslabšanje, neželena reakcija z eozinofilijo in sistemskimi simptomi (sindrom DRESS) Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate 
Krospovidon (E1202) Brezvodni koloidni silicijev dioksid Magnezijev stearat (E470b) Laktoza monohidrat
This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill) - zidovudine for HIV infection 
To je še posebej pomembno, če jemljete: - druga zdravila za zdravljenje revmatoidnega artritisa, kot so antimalariki (npr. klorokin in hidroksiklorokin), intramuskularno ali peroralno dano zlato, D-penicilamin, azatioprin in druga imunosupresivna zdravila (npr. metotreksat), saj te kombinacije niso priporočljive,varfarin in druga peroralna zdravila, ki se uporabljajo za redčenje krvi, ker so potrebne kontrole, da bi zmanjšali tveganje neželenih učinkov tega zdravila, - teriflunomid za multiplo sklerozo, - repaglinid, pioglitazon, nateglinid, ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel, ali topotekan za raka, - duloksetin za depresijo, inkontinenco urina ali bolezen ledvic pri sladkornih bolnikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - peroralni kontraceptivi (vključno z etinilestradiolom and levonorgestrelom), - cefaklor, benzilpenicillin (penicillin G), ciprofloksacin za okužbe,
Excipients with known effect Each tablet contains 78 mg of lactose monohydrate. 
Pomožne snovi z znanim učinkom Ena tableta vsebuje 78 mg laktoze monohidrat.
often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis), - if you have any liver problems, - if you have moderate to severe kidney problems, - if you have severely low numbers of proteins in your blood (hypoproteinaemia), - if you suffer from any problem which affects your immune system (e.g. AIDS), - if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you are pregnant, think you may be pregnant, or are breast-feeding. 
6) ali ste alergični na teriflunomid (ki se uporablja za zdravljenje multiple skleroze), - če imate kakršnekoli težave z jetri, - če imate zmerne do hude težave z ledvicami, - če imate zelo znižano število beljakovin v krvi (hipoproteinemija), - če kakršnakoli težava vpliva na vaš imunski sistem (npr. AIDS), - če imate kakršnekoli težave z vašim kostnim mozgom ali imate v krvi zmanjšano število rdečih krvnih celic, belih krvnih celic ali krvnih ploščic, - če imate kakšno resno okužbo, - če ste noseči, mislite, da bi lahko bili noseči ali dojite.
Excipients with known effect Each tablet contains 72 mg of lactose monohydrate. 
Pomožne snovi z znanim učinkom Ena tableta vsebuje 72 mg laktoze monohidrat.
Do not take Arava if you are, or think you may be pregnant. 
Ne jemljite zdravila Arava, če ste ali mislite, da ste noseči.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Arava. 
Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Arava je treba upoštevati dolg razpolovni čas leflunomida.
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, - 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, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy). 
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 težave s pljuči (intersticijska bolezen pljuč ali pljučna hipertenzija), - nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
- if you are male and wish to father a child. As it can not be excluded that Arava passes into semen, reliable contraception should be used during treatment with Arava. 
Obstaja možnost, da se zdravilo Arava izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Arava uporabljati zanesljivo kontracepcijo.
Arava 20 mg film-coated tablets are yellowish to ochre and triangular. 
Arava 20 mg filmsko obložene tablete so rumenkaste do okraste barve in trikotne oblike.
- an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy). 
- zvišanje nekaterih vrednosti jetrnih testov, - zvečano izpadanje las, - ekcem, suha koža, izpuščaj, srbenje, - tendonitis (bolečina, običajno v rokah in nogah, ki jo povzroči vnetje membrane, ki obdaja tetive), - zvišanje določenih encimov v krvi (kreatin-fosfokinaza), - težave z živci rok ali nog (periferna nevropatija).
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000 
Smukec (E553b) Hipromeloza (E464) Titanov dioksid (E171) Makrogol 8000
Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000 
Titanov dioksid (E171) makrogol 8000
Arava 20 mg 
PODATKI V BRAILLOVI PISAVI Arava 20 mg
Arava 100 mg 
PODATKI V BRAILLOVI PISAVI Arava 100 mg
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve registracije: 02 september 1999
How to store Arava 
Shranjevanje zdravila Arava
Arava 10 mg 
PODATKI V BRAILLOVI PISAVI Arava 10 mg
- a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe, sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). 
Zelo redki neželeni učinki (prizadenejo lahko največ 1 od 10.000 bolnikov) izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza), hude in potencialno hude alergijske reakcije, vnetje majhnih žil (vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom), vnetje trebušne slinavke (pankreatitis), resne poškodbe jeter, kot sta odpoved jeter ali nekroza, ki sta lahko usodni, hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the filmcoating. 
- Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171), makrogol 8000 in rumeni železov oksid (E172) v filmski oblogi.
Arava 20 mg film-coated tablets leflunomide 
Arava 20 mg filmsko obložene tablete leflunomid
Arava 100 mg film-coated tablets leflunomide 
Arava 100 mg filmsko obložene tablete leflunomid
Each film-coated tablet contains 20 mg leflunomide. 
Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, 
Ne jemljite zdravila Arava - če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo povišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji,
Arava 10 mg film-coated tablets leflunomide 
Arava 10 mg filmsko obložene tablete leflunomid
- a slight decrease in the number of white blood cells (leucopenia), - mild allergic reactions, - loss of appetite, weight loss (usually insignificant), - tiredness (asthenia), - headache, dizziness, - abnormal skin sensations like tingling (paraesthesia), - mild increase in blood pressure, - colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, 
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) - rahlo zmanjšanje števila belih krvnih celic (levkopenija), - blage alergijske reakcije, - izguba apetita, hujšanje (ponavadi nepomembno), - utrujenost (astenija), - glavobol, omotica, - nenormalne kožne zaznave, npr. mravljinčenje (parestezije), - blago zvišanje krvnega tlaka, - kolitis, - driska, - slabost, bruhanje, - vnetje v ustih ali razjede v ustih, - bolečine v trebuhu,
Contents of the pack and other information What Arava contains 
Shranjevanje zdravila Arava Vsebina pakiranja in dodatne informacije
One film-coated tablet contains 100 mg of leflunomide. 
Ena filmsko obložena tableta vsebuje 100 mg leflunomida.
One film-coated tablet contains 10 mg of leflunomide. 
Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
Sanofi-Aventis Deutschland GmbH 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi-Aventis Deutschland GmbH
Arava 20 mg film-coated tablets 
IME ZDRAVILA Arava 20 mg filmsko obložene tablete
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase). 
Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov) - zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija); blago zmanjšanje števila belih krvnih celic (levkopenija); zmanjšanje števila vseh krvnih celic (pancitopenija), - resno zvišanje krvnega tlaka, - vnetje pljuč (intersticijska bolezen pljuč), - zvišanje nekaterih vrednosti jetrnih testov, kar se lahko razvije v resne bolezni, npr. hepatitis in zlatenico, - hude okužbe, imenovane sepsa, ki so lahko usodne, - zvišanje določenih encimov v krvi (laktat-dehidrogenaza).
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000. 
(E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
Arava 100 mg film-coated tablets 
IME ZDRAVILA Arava 100 mg filmsko obložene tablete
Arava 10 mg film-coated tablets 
IME ZDRAVILA Arava 10 mg filmsko obložene tablete
EU/1/99/118/001 30 tablets EU/1/99/118/002 100 tablets 
EU/1/99/118/002 100 tablet
EU/1/99/118/003 30 tablets EU/1/99/118/004 100 tablets 
EU/1/99/118/004 100 tablet
EU/1/99/118/009 3 tablets 
EU/1/99/118/006 100 tablet
Yellow ferric oxide (E172) 
Hipromeloza (E464)
The study is ongoing. 
Študija še poteka.
Wash your hands before initiating the constitution. 
Pred začetkom rekonstitucije si umijte roke.
calendar pack: Monday Tuesday Wednesday Thursday Friday 
Koledarsko pakiranje: ponedeljek torek sreda četrtek petek sobota nedelja
Effects on growth and development in paediatric patients 
Učinki na rast in razvoj pri pediatričnih bolnikih
After constitution 
Po rekonstituciji
These results are difficult to interpret in the context of chronic diseases such as CML, and require long-term follow-up. 
Te rezultate je težko interpretirati v okviru kroničnih bolezni, kot je KML, in zahtevajo dolgoročno spremljanje.
Sulphur dioxide (E220) 
Žveplov dioksid (E220)
% with MR4.5 
% z MR4.5
Take the next scheduled dose at the regular time. 
Naslednji predvideni odmerek vzemite ob običajnem času.
Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016 
Datum prve odobritve: 20. november 2006 Datum zadnjega podaljšanja: 15. julij 2016
Immune system: severe allergic reaction 
Imunski sistem: resna alergijska reakcija
Outer Carton: PC: 
Škatla: PC:
These results are consistent with those seen at 12, 24 and 36 months. 
Ti rezultati se skladajo z rezultati po 12, 24 in 36 mesecih.
Take your tablets at the same time every day. 
Tablete jemljite vsak dan ob istem času.
Percent (%) of patients 
Odstotek (%) bolnikov
The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. 
Odmerek je treba preračunati vsake 3 mesece na osnovi spremembe telesne mase, po potrebi pa tudi pogosteje.
• Wash your hands before and after each use. 
• Pred in po vsaki uporabi si umijte roke.
Patients continuing treatment should be monitored periodically. 
Bolnike, pri katerih se zdravljenje nadaljuje, je treba redno spremljati.
Brain: loss of memory 
Možgani: izguba spomina.
These are blisters showing the days of the week. 
To so pretisni omoti, na katerih so označeni dnevi v tednu.
Months since randomisation 
Meseci od randomizacije
This case was a Grade 1 osteopenia. 
Ta primer je bila osteopenija stopnje 1.
Powder for oral suspension 5 to less than 10 
Prašek za peroralno suspenzijo 5 do manj kot 10
After constitution The oral suspension is stable for 60 days. 
Po rekonstituciji Peroralna suspenzija je stabilna 60 dni.
• Take SPRYCEL oral suspension on an empty or full stomach. 
• SPRYCEL peroralno suspenzijo vzemite na prazen ali poln želodec.
Look at the measurements on the side of the syringe so you can see how much to fill it before you begin. 
Oglejte si merilne oznake na strani brizge, da boste pred začetkom lahko videli koliko jo lahko napolnite.
The observed food effects do not represent clinically relevant changes in exposure. 
Opaženi vpliv hrane ne predstavlja klinično pomembnih sprememb pri izpostavljenosti.
The random inter-occasion variability in exposure is not expected to affect the cumulative exposure and efficacy or safety. 
Pričakuje se, da naključna variabilnost med različnimi situacijami v primeru izpostavljenosti ne vpliva na kumulativno izpostavljenost in učinkovitost ali varnost.
28 days apart). 
28-dnevnim razmikom).
What you need to know before using this medicine 
Kaj morate vedeti pred uporabo tega zdravila
• Review total prescribed dose and determine number of milliliters (mL) you will need. 
• Preverite skupni predpisani odmerek in določite število potrebnih mililitrov (ml).
After constitution: Store in a refrigerator. 
Po rekonstituciji Shranjujte v hladilniku.
140 mg once daily n = 304 
140 mg enkrat na dan n = 304
This procedure should be performed on a clean surface. 
Rekonstitucijo morate opraviti na čisti površini.
These are cumulative rates representing minimum follow up for the timeframe specified. 
To so kumulativni deleži, ki predstavljajo najmanjše obdobje spremljanja za določeno časovno obdobje.
Do not take dispersed tablets. 
Ne jemljite zdrobljenih tablet.
• A small container filled with water to use to rinse the syringe. 
• Majhno posodo, napolnjeno z vodo, ki jo boste uporabili pri spiranju brizge.
Other side effects that have been reported with frequency not known (cannot be estimated from the available data) 
Ostali neželeni učinki, o katerih obstajajo poročila, njihova pogostnost pa ni znana (je ni mogoče oceniti iz razpoložljivih podatkov)
There are arrows to show the next tablet to be taken according to your treatment schedule. 
Puščice kažejo na naslednjo tableto, ki jo morate vzeti glede na vaš režim zdravljenja.
There may be a vacuum pulling the plunger back into barrel. 
Morda je prisoten vakuum, ki lahko bat potiska nazaj v brizgo.
All patients n=167 
Vsi bolniki n=167
• If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10. 
• Če je za dajanje celotnega predpisanega odmerka potrebna še uporaba drugega odmerka, ponovite korake od 3 do 10.
Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies. 
Bolniki z nenadzorovanim ali pomembnejšim kardiovaskularnim obolenjem niso bili vključeni v klinične študije.
f In the post-marketing setting, individual cases of Stevens-Johnson syndrome have been reported. 
f Po pridobitvi dovoljenja za promet so poročali o posameznih primerih Stevens-Johnsonovega sindroma.
• Do not wash in a dishwasher. 
• Ne perite v pomivalnem stroju.
Pulmonary arterial hypertension (PAH) 
Pljučna arterijska hipertenzija (PAH)
* For additional details, see section "Description of selected adverse reactions" 
* Za dodatne podrobnosti glejte poglavje "Opis izbranih neželenih učinkov"
However, E255K and F317L were also detected prior to treatment. 
Vendar pa so pred zdravljenjem odkrili tudi E255K in F317L.
When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%. 
Če ta delež temeljimo na 85 bolnikih z ovrednotenimi ocenami Ig/TCR, ocena znaša 89,4%.
• Check to make sure the patient has swallowed all of the dose. 
• Preverite, če je bolnik pogoltnil celoten odmerek.
Instructions for administration to the patient 
Navodila za dajanje bolniku
Of note, pleural effusion was reported in 7 (5.6%) patients in this group, and is therefore not included in the table. 
Opomnimo naj, da so o plevralnem izlivu poročali pri 7 (5,6%) bolnikih iz te skupine in zato ni vključen v to preglednico.
Pleural effusion did not impair the ability of patients to obtain a response. 
Plevralni izliv ni zmanjšal sposobnosti bolnikov za dosego odziva.
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect. 
Zdravnik bo redno nadziral vaše zdravstveno stanje in preverjal, če ima zdravilo SPRYCEL želeni učinek.
24 months 36 months 48 months 60 months p=0.0021 
24 mesecev 36 mesecev 48 mesecev 60 mesecev p=0,0021
at least 45 
najmanj 45
The potential for displacement and its clinical relevance are unknown. 
Potencial za izpodrivanje z vezavnih mest in njegov klinični pomen nista znana.
Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension. 
2. korak: Plastenko takoj obrnite in jo močno stresajte najmanj 60 sekund, da dobite enakomerno suspenzijo.
Benzoic acid and benzoates 
Benzojska kislina in benzoati