natgillin/translations-raw huggingface dataset:
Leflunomide ratiopharm 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet. 
Leflunomid ratiopharm 20 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 8 mm ter zarezo za prelom na eni strani.
- The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating 
• Pomožne snovi so: laktoza monohidrat, nizko substituirana hidroksipropil celuloza, vinska kislina, natrijev lavrilsulfat in magnezijev stearat v jedru tablete ter lecitin (sojina zrna), poli(vinil alkohol), smukec, titanov dioksid (E171) in ksantan gumi v filmski oblogi.
- If you have any further questions, ask your doctor, pharmacist or nurse. 
• Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with a not known frequency. 
Z neznano pogostnostjo se lahko pojavijo neželeni učinki, kot je ledvična odpoved, zmanjšana koncentracija sečne kisline v krvi, pljučna hipertenzija, neplodnost pri moških (izgine po prenehanju uporabe tega zdravila), kožni lupus (značilen izpuščaj/eritem na predelih kože, ki so izpostavljeni svetlobi) luskavica (ki se pojavi na novo ali poslabšanje le te) in sindrom DRESS.
Very rare side effects (may affect up to 1 in 10,000 people) 
Zelo redki neželeni učinki (prizadenejo lahko največ 1 od 10.000 bolnikov)
Leflunomide ratiopharm is for oral use. 
Tablete Leflunomid ratiopharm so za peroralno uporabo.
Leflunomide ratiopharm contains lactose. 
Zdravilo Leflunomid ratiopharm vsebuje laktozo.
- a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the body. 
- zdravilo imenovano holestiramin (uporablja se za zniževanje zvišanega holesterola) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Leflunomid ratiopharm, ki jo telo absorbira, Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Leflunomid ratiopharm.
Other medicines and Leflunomide ratiopharm 
Druga zdravila in zdravilo Leflunomid ratiopharm
Certain vaccinations should not be given while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment. 
Leflunomid ratiopharm in določen čas po koncu tega zdravljenja ne sme uporabljati.
The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5). 
Uporaba leflunomida z antimalariki, ki se uporabljajo pri revmatičnih boleznih (npr. s klorokinom ali hidroksiklorokinom), intramuskularnim ali peroralnim zlatom, D-penicilaminom, azatioprinom in drugimi imunosupresivnimi zdravili, vključno z zaviralci tumorje nekrotizirajočim faktorjem alfa,
Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline). 
Leflunomid se presnovi v en glavni (A771726) in več stranskih presnovkov, med katerimi je tudi
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,
It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised. 
Nadziranje jetrnih encimov je priporočljivo nadaljevati tudi po prekinitvi zdravljenja z leflunomidom,
Rare side effects (may affect up to 1 in 1,000 people) 
Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov))
How to store Leflunomide ratiopharm Contents of the pack and other information 
Shranjevanje zdravila Leflunomid ratiopharm Vsebina pakiranja in dodatne informacije
Postmarketing studies 
Študije, izvedene po prihodu zdravila na trg
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately. 
Čim se na koži in/ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila
You will normally take Leflunomide ratiopharm over long periods of time. 
Običajno boste zdravilo Leflunomid ratiopharm jemali dolgo časa.
How to take Leflunomide ratiopharm 
Kako jemati zdravilo Leflunomid ratiopharm
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PLASTENKA ŠKATLA
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide ratiopharm. 
Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid ratiopharm je treba upoštevati dolg razpolovni čas leflunomida.
Name and address of the manufacturers responsible for batch release 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE Ime in naslov izdelovalcev, odgovornih za sproščanje serije
Male patients should be aware of the possible male-mediated foetal toxicity. 
Zaploditev otroka (priporočila za moške) Moški bolniki se morajo zavedati možnih toksičnih učinkov za plod, ki jih lahko posreduje moški.
Cases of peripheral neuropathy have been reported in patients receiving leflunomide. 
Periferna nevropatija Pri bolnikih, ki so jemali zdravilo Leflunomid ratiopharm, so poročali o primerih periferne nevropatije.
Tell your doctor immediately and stop taking Leflunomide ratiopharm: 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 2. 
• 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.
Effect on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo. 
Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax cefaklorja za 1,43-krat in njegove povprečne AUC za 1,54-krat; to kaže, da A771726 in vivo zavira OAT3.
Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel) There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726. 
Po ponavljajočih se odmerkih A771726 se je povprečna Cmax etinilestradiola povečala za 1,58-krat in njegova povprečna AUC0-24 za 1,54-krat; povprečna Cmax levonorgestrela se je povečala za 1,33-krat in povprečna AUC0-24 za 1,41-krat.
- The active substance is leflunomide. 
• Zdravilna učinkovina je leflunomid.
The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) 
Pediatrična populacija Farmakokinetiko A771726 po peroralni uporabi leflunomida so raziskali pri 73 pediatričnih bolnikih,
See sextion 4. 
V preskušanju II.
- If you get any side effects, talk to your doctor, pharmacist or nurse. 
• Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm. 
Med zdravljenjem z zdravilom Leflunomid ratiopharm ni priporočljivo pitje alkohola.
Psychiatric disorders Uncommon: 
Bolezni sečil neznana:
One film-coated tablet contains 20 mg of leflunomide. 
Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila Leflunomid ratiopharm, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
What Leflunomide ratiopharm looks like and contents of the pack 
Izgled zdravila Leflunomid ratiopharm in vsebina pakiranja
Leflunomide ratiopharm 10 mg tablets Leflunomide 
Leflunomid ratiopharm 10 mg tablete leflunomid
Leflunomide ratiopharm 20 mg tablets Leflunomide 
Leflunomid ratiopharm 20 mg tablete leflunomid
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: before initiation of leflunomide, every two weeks during the first six months of treatment, and every 8 weeks thereafter (see section 4.4). 
Alanin-aminotransferazo (ALT) (oz. serumsko glutamat-piruvat-transferazo (SGPT)) in celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov, je treba preveriti sočasno in z enako pogostnostjo:
Each tablet contains 20 mg of leflunomide. 
Ena tableta vsebuje 20 mg leflunomida.
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis, 
• Bolniki z občutno okvarjenim delovanjem kostnega mozga ali izrazito anemijo, levkopenijo,
Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. 
18 % in njegovo povprečno AUC za 55 %; to kaže, da A771726 in vivo morda šibko inducira CYP1A2.
Common side effects (may affect up to 1 in 10 people) 
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov)
If a patient taking leflunomide develops a peripheral neuropathy, consider discontinuing leflunomide therapy and performing the drug elimination procedure (see section 4.4). 
Če bolnik med jemanjem zdravila Leflunomid ratiopharm razvije periferno nevopatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid ratiopharm in o izvajanju postopka za eliminacijo zdravila.
Leflunomide ratiopharm contains soya lecithin 
Zdravilo Leflunomid ratiopharm vsebuje sojin lecitin.
Each tablet contains 10 mg of leflunomide. 
Ena tableta vsebuje 10 mg leflunomida.
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 
- 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,
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 
• Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom
Effect of leflunomide on other medicinal products: 
Vpliv leflunomida na druga zdravila: Peroralni kontraceptivi
- 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, 
• izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza), • hude in potencialno hude alergijske reakcije,
Leflunomide ratiopharm 10 mg film-coated tablets 
Leflunomid ratiopharm 10 mg filmsko obložene tablete
tendon rupture 
pretrganje tetive
In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism. 
1A2, 2C19 in 3A4 citokroma P450 (CYP).
Leflunomide ratiopharm 20 mg film-coated tablets 
Leflunomid ratiopharm 20 mg filmsko obložene tablete
- if you are male and wish to father a child. As it can not be excluded that Leflunomide ratiopharm passes into semen, reliable contraception should be used during treatment with Leflunomide ratiopharm. 
Obstaja možnost, da se zdravilo Leflunomid ratiopharm izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid ratiopharm uporabljati zanesljivo kontracepcijo.
Leflunomide ratiopharm contains lactose 
Shranjevanje zdravila Leflunomid ratiopharm
35 μg/ml. 
0,02 mg/l):
Leflunomide ratiopharm 10 mg film-coated tablets Leflunomide 
Leflunomid ratiopharm 10 mg filmsko obložene tablete leflunomid
Leflunomide ratiopharm 20 mg film-coated tablets Leflunomide 
Leflunomid ratiopharm 20 mg filmsko obložene tablete leflunomid
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis. 
nevtropenijo ali trombocitopenijo, katerih vzrok ni revmatoidni ali psoriatični artritis.
• Physician Leaflet 
• pred uvedbo leflunomida
If you forget to take Leflunomide ratiopharm 
Kaj morate vedeti, preden boste vzeli zdravilo Leflunomid ratiopharm Ne jemljite zdravila Leflunomid ratiopharm
(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). 
• utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna,
Cardiac disorders Common: 
Psihiatrične motnje Občasni:
a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood. 
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,
• Patients with severe immunodeficiency states, e.g. AIDS, 
• če kakršnakoli težava vpliva na vaš imunskisistem (npr. AIDS),
Invented name 
EU Številka Izmišljeno ime
United Kingdom Teva Uk Limited 
Združeno kraljestvo Teva Uk Limited
United Kingdom Pronova Biopharma Norge As 
Združeno kraljestvo Pronova Biopharma Norge As
United Kingdom Mercury Pharmaceuticals Ltd. 
Združeno kraljestvo Mercury Pharmaceuticals Ltd.
1000mg Capsule 
1000 mg kapsula
Fish Oil 1000mg Capsule 
ribje olje 1000 mg kapsula
Ratiopharm Gmbh Omega-3 Ratiopharm Omega-3-Acid Ethyl Esters 90 1000mg 
Ratiopharm Gmbh Omega-3 Ratiopharm omega-3-kislinski etilestri 90 1000 mg kapsula
United Kingdom Strides Arcolab International Limited 
Združeno kraljestvo Strides Arcolab International Limited
Esters Of Unsaturated Fatty Acids 500mg Capsule 
Esapent estri nenasičenih maščobnih kislin 500 mg kapsula
Triglycerides Medium Chain 1qs Capsule, Lecithin Soya 1qs Capsule, Omega-3-Acid Ethyl Esters 90 1000mg Capsule 
Romunija srednjeverižni trigliceridi 1qs kapsula, sojin lecitin 1qs kapsula, omega-3kislinski etilestri 90
Ácidos Omega 3 Aristo Omega-3-Acid Ethyl Esters 1000mg Capsule 
Ácidos Omega 3 Aristo omega-3-kislinski etilestri 1000 mg kapsula
Docosahexaenoic Acid 60mg Capsule, Eicosapentaenoic Acid 90mg Capsule 
Prolipid dokozaheksaenojska kislina 60 mg kapsula, eikozanpentanojska kislina 90 mg kapsula
Docosahexaenoic Acid 115mg Capsule, Eicosapentanoic Acid/Docosahexaenoic Acid 170mg Capsule 
Pazeril dokozaheksaenojska kislina 115 mg kapsula, eikozanpentanojska kislina/dokozaheksaenoj ska kislina 170 mg kapsula
Acidos Omega 3 Stada Omega-3-Acid Ethyl Esters 90 1000mg 
Acidos Omega 3 Stada omega-3-kislinski etilestri 90 1000 mg kapsula
Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 
Eskim omega-3-kislinski etilestri 90 s specifično sestavo EPA in DHA nad 85 % 500mg kapsula
Omega-3 Fatty Acids 1000mg Capsule 
Tevocor omega-3 maščobne kisline 1000 mg kapsula
Esters Of Unsaturated Fatty Acids 1000mg Capsule 
Esapent estri nenasičenih maščobnih kislin 1000 mg kapsula
Docosahexaenoic Acid 120mg Capsule, Eicosapentaenoic Acid 180mg Capsule 
Prolipid dokozaheksaenojska kislina 120 mg kapsula, eikozanpentanojska kislina 180 mg kapsula
Ácidos Omega 3 Tarbis Docosahexaenoic Acid 380mg Capsule, 
Ácidos Omega 3 Kern Pharma etilester eikozapentaenojske kisline 460 mg kapsula, etilester dokozaheksaenojske kisline 380 mg kapsula
Docosahexaenoic Acid 527mg/5ml, Eicosapentaenoic Acid 791mg/5ml 
Farlipid dokozaheksaenojska kislina 527 mg/5 ml, eikozapentaenojska kislina 791 mg/5 ml peroralna raztopina
Docosahexaenoic Acid 115mg Capsule, Vitamin D 10 I.U.G, 
Maxepa dokozaheksaenojska kislina 115 mg kapsula, vitamin D 10 i.e./g, eikozanpentanojska kislina 170 mg kapsula, vitamin A 100 i.e./g
Docosahexaenoic Acid 527mg/5ml, Eicosapentanoic Acid/Docosahexaenoic Acid 791mg/5ml 
Pazeril dokozaheksaenojska kislina 527 mg/5 ml, eikozanpentanojska kislina/dokozaheksaenoj ska kislina 791 mg/5 ml peroralna raztopina
Eicosapentaenoic Acid 170mg Capsule, Vitamin A 1 I.U.G 
Farlipid dokozaheksaenojska kislina 115 mg kapsula, vitamin D 1 i.e./g, eikozapentaenojska kislina 170 mg kapsula, vitamin A 1 i.e./g
Verisfield (Uk) Ltd Lipemia 
Verisfield (Uk) Ltd Lipemia ribje olje 0,5 ml/ml peroralna emulzija
Docosahexaenoic Acid 265mg/5ml, Eicosapentaenoic Acid 390mg/5ml 
Farlipid dokozaheksaenojska kislina 265 mg/5 ml, eikozapentaenojska kislina 390 mg/5 ml peroralna emulzija
Eicosapentaenoic Acid 791mg/5ml, Vitamin A 100 I.U.G 
Maxepa dokozaheksaenojska kislina 527 mg/5 ml, vitamin D 10 i.e./g, eikozapentaenojska kislina 791 mg/5 ml, vitamin A 100 i.e./g peroralna raztopina
Docosahexaenoic Acid Ethyl Ester 437mg Capsule 
Tropolipid etilester eikozapentaenojske kisline 430 mg kapsula, etilester dokozaheksaenojske kisline 437 mg kapsula
Pharmaceutical Form Route of administration 
Številka (EU) dovoljenja za promet zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. 
Zdravljenje z zdravilom Pioglitazon Actavis je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
The full EPAR for Pioglitazone Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pioglitazon Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Pioglitazon Actavis, veljavno po vsej Evropski uniji, izdala 15. marca 2012.
This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazon Actavis.
Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. 
Zdravilo Pioglitazon Actavis se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
The company that markets Pioglitazone Actavis will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting. 
Družba, ki trži zdravilo Pioglitazon Actavis, bo za zdravnike, ki bodo predpisovali zdravilo, pripravila izobraževalno gradivo, ki bo vključevalo možno tveganje za srčno popuščanje in rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter njegovi prekinitvi, če to bolnikom ne koristi več.
Pioglitazone Actavis 
Pioglitazon Actavis pioglitazon
The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. 
Zdravilna učinkovina v zdravilu Pioglitazon Actavis, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
The Committee recommended that Pioglitazone Actavis be approved for use in the EU. 
Priporočil je, da se zdravilo Pioglitazon Actavis odobri za uporabo v EU.