FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (Creatinine Clearance < 30 mL/min/1.73m
Slovenian: Pri bolnikih s hudo jetrno okvaro (stopnja C po Child-Pughovi lestvici) ali hudo ledvično okvaro (očistek kreatinina < 30 ml/min/1,73 m2) je treba morebitna tveganja, povezana z uporabo tega zdravila, oceniti glede na zdravstvene potrebe (glejte poglavje 5.2).
English: Dextromethorphan
Slovenian: Dekstrometorfan
English: • medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir,
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje okužbe z virusom HIV in aidsom, npr. atazanavir,
English: • teeth grinding (bruxism), confusion, depressed mood, depression, disorientation (e.g. difficulty sensing time, direction, and recognition of people and places), early morning awakening,
Slovenian: • škrtanje z zobmi (bruksizem), zmedenost, depresivno razpoloženje, depresija, dezorientacija (npr. težave pri dojemanju časa, smeri in prepoznavanju oseb in krajev), zgodnje jutranje prebujanje, zmanjšana čustvena izraznost (apatičnost), halucinacije, impulzivno vedenje, indiferentnost, nespečnost, nemir, motnje spanja
English: Before treatment with Nuedexta is initiated patients must be fully evaluated to confirm the diagnosis of PBA. Central to the diagnosis are the presence of an underlying neurological condition known to cause PBA, and confirmation that the episodes of emotional expression do not reflect the patient's emotional state or mood.
Slovenian: Za postavitev diagnoze sta ključna osnovno nevrološko stanje, za katerega je znano, da povzroča PBP, in potrditev, da epizode čustvenega izražanja niso skladne ali sorazmerne z bolnikovim čustvenim stanjem ali razpoloženjem.
English: MAOIs
Slovenian: Omotica
English: What NUEDEXTA contains
Slovenian: Kaj vsebuje zdravilo NUEDEXTA
English: NUEDEXTA contains lactose
Slovenian: Zdravilo NUEDEXTA vsebuje laktozo
English: Tabulated summary of adverse reactions
Slovenian: Povzetek neželenih učinkov v obliki preglednice
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora redki
English: • rare (≥1/10,000 to <1/1,000)
Slovenian: • redki (≥1/10.000 do <1/1.000);
English: NUEDEXTA 23 mg/9 mg hard capsules
Slovenian: NUEDEXTA 23 mg/9 mg trde kapsule
English: • Summary of Product Characteristics (SmPC)
Slovenian: • povzetek glavnih značilnosti zdravila;
English: INFORMATION IN BRAILLE NUEDEXTA 15 mg/9 mg
Slovenian: NUEDEXTA 15 mg/9 mg
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Each bottle is packed in a carton.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) s pokrovčkom iz polipropilena, ki je varen za otroke.
English: INFORMATION IN BRAILLE NUEDEXTA 23 mg/9 mg
Slovenian: NUEDEXTA 23 mg/9 mg
English: NUEDEXTA 15 mg/9 mg hard capsules NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Slovenian: NUEDEXTA 15 mg/9 mg trde kapsule NUEDEXTA 23 mg/9 mg trde kapsule dekstrometorfan/kinidin
English: • medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol,
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje shizofrenije in drugih psihotičnih motenj, npr.
English: Chest discomfort, Chest pain, Chills, Feeling hot, Gait disturbance, Influenza like illness, Pyrexia, Oxygen
Slovenian: Splošne težave in spremembe na mestu aplikacije neugodje v prsnem košu, bolečina v prsnem košu, mrzlica, občutek vročine, motnje hoje, gripi podobna bolezen, pireksija, zmanjšana nasičenost s kisikom
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and memantine 20 mg/day.
Slovenian: Opravili so študijo medsebojnega delovanja večjega odmerka kombinacije dekstrometorfana/kinidina (23 mg dekstrometorfana/26 mg kinidina) in memantina v odmerku 20 mg/dan.
English: Adverse reactions of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis.
Slovenian: Neželeni učinki pri prevelikem odmerjanju dekstrometorfana so navzea, bruhanje, stupor, koma, respiratorna depresija, epileptični napadi, tahikardija, čezmerna vzdražljivost in toksična psihoza.
English: NUEDEXTA 15 mg/9 mg hard capsules
Slovenian: NUEDEXTA 15 mg/9 mg trde kapsule
English: Gastric lavage may be of use.
Slovenian: Izpiranje želodca je lahko koristno.
English: • diarrhoea, nausea
Slovenian: • diareja, navzea
English: Stop taking NUEDEXTA and seek medical attention immediately if any of the above symptoms occur.
Slovenian: Če opazite katerega koli od zgoraj navedenih simptomov, prenehajte jemati zdravilo NUEDEXTA in takoj poiščite zdravniško pomoč.
English: Common Diarrhoea, Nausea Abdominal pain, Constipation, Dry mouth, Flatulence, Stomach discomfort, Vomiting
Slovenian: Bolezni prebavil pogosti diareja, navzea bolečina v trebuhu, zaprtost, suha usta, flatulenca, neugodje
English: Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Slovenian: Opečnato rdeča želatinasta kapsula velikosti 1 z belo oznako „DMQ / 20-10“.
English: NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Slovenian: NUEDEXTA 23 mg/9 mg trde kapsule dekstrometorfan/kinidin
English: How to store NUEDEXTA
Slovenian: Shranjevanje zdravila NUEDEXTA
English: Desipramine (CYP2D6 substrate)
Slovenian: Dezipramin (substrat encima CYP2D6)
English: Musculoskeletal stiffness, Myalgia, Neck pain, Pain in
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva skeletno-mišična togost, mialgija, bolečina v vratu, bolečina
English: CYP2D6 substrates
Slovenian: Substrati encima CYP2D6
English: Each NUEDEXTA 23 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Slovenian: Ena kapsula zdravila NUEDEXTA 23 mg/9 mg vsebuje dekstrometorfanijev bromid monohidrat, kar je enako 23,11 mg dekstrometorfana, in kinidinijev sulfat dihidrat, kar je enako 8,69 mg kinidina.
English: Each NUEDEXTA 15 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Slovenian: Ena kapsula zdravila NUEDEXTA 15 mg/9 mg vsebuje dekstrometorfanijev bromid monohidrat, kar je enako 15,41 mg dekstrometorfana, in kinidinijev sulfat dihidrat, kar je enako 8,69 mg kinidina.
English: NUEDEXTA 15 mg/9 mg hard capsules dextromethorphan / quinidine
Slovenian: NUEDEXTA 15 mg/9 mg trde kapsule dekstrometorfan/kinidin
English: Following repeated doses of NUEDEXTA 23 mg / 9 mg and NUEDEXTA 15 mg / 9 mg, maximal plasma concentrations (Cmax) of dextromethorphan are reached approximately 3 to 4 hours after dosing and maximal plasma concentrations of quinidine are reached approximately 2 hours after dosing.
Slovenian: Po večkratnih odmerkih zdravila NUEDEXTA 23 mg/9 mg in NUEDEXTA 15 mg/9 mg so najvišje plazemske koncentracije (Cmax.)
English: Dose adjustment is not required in patients with a non-functional CYPD2D6 enzyme, referred to as poor metabolisers (PMs).
Slovenian: Pri bolnikih z nedelujočim encimom CYP2D6, tj. počasnih metabolizatorjih (PM), odmerka ni treba prilagajati.
English: Tell your doctor immediately if you experience severe symptoms including agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Slovenian: Če opazite resne simptome, ki lahko vključujejohudo tesnobo, visok krvni tlak, nemir, mišične krče in trzanje, visoko telesno temperaturo, prekomerno potenje, tresavico in tremor, takoj obvestite svojega zdravnika.
English: • certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
Slovenian: dezipraminom, paroksetinom, imipraminom in amitriptilinom ter nefazodonom;
English: The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.
Slovenian: Priporočeni začetni odmerek zdravila NUEDEXTA je 15 mg/9 mg enkrat na dan. Priporočeni razpored titracije odmerka je naslednji:
English: • Abnormal faeces, Dyspepsia, Gastritis, Hypoaesthesia oral, Paraesthesia oral, Proctalgia, Tongue dry Hepatobiliary disorders Uncommon Increased hepatic enzymes (GGT, AST, ALT) Cholelithiasis, blood bilirubin increased, Liver function test
Slovenian: Bolezni jeter, žolčnika in žolčevodov povišana raven jetrnih encimov (GGT, AST, ALT) holelitiaza, povišana raven bilirubina v krvi, nenormalni izvidi preiskav jetrnega delovanja
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Slovenian: Ena kapsula vsebuje dekstrometorfanijev bromid monohidrat, kar je enako 23,11 mg dekstrometorfana, in kinidinijev sulfat dihidrat, kar je enako 8,69 mg kinidina.
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Slovenian: Ena kapsula vsebuje dekstrometorfanijev bromid monohidrat, kar je enako 15,41 mg dekstrometorfana, in kinidinijev sulfat dihidrat, kar je enako 8,69 mg kinidina.
English: Please ask your doctor if you are not sure, if any of the above applies to you.
Slovenian: Če niste prepričani, ali zgoraj navedeno velja za vas, se posvetujte s svojim zdravnikom.
English: BOTTLE LABEL (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
Slovenian: ŠKATLA ZA PLASTENKO (60 trdih kapsul) - NUEDEXTA 23 mg/9 mg kapsule
English: BOTTLE LABEL (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Slovenian: ŠKATLA ZA PLASTENKO (60 trdih kapsul) - NUEDEXTA 15 mg/9 mg kapsule
English: In a drug-drug interaction study, a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) was added to paroxetine at steady state.
Slovenian: V študiji medsebojnega delovanja se je paroksetinu v stanju dinamičnega ravnovesja dodal večji odmerek kombinacije dekstrometorfana/kinidina (23 mg dekstrometorfana/26 mg kinidina).
English: Uncommon Motion sickness, Tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni kinetoza, tinitus
English: PBA is a consequence of neurological diseases affecting the brain, or brain, injury and is defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to the patient's emotional state or mood.
Slovenian: Opredeljena je z epizodami nehotenega čustvenega izražanja s smehom in/ali jokom, ki ga ni mogoče nadzorovati in ni skladno ali sorazmerno z bolnikovim čustvenim stanjem ali razpoloženjem.
English: Quinidine at higher doses has also been associated with a lupus-like syndrome involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, haemolytic anaemia, vasculitis, uveitis, angioedema, agranulocytosis, the sicca syndrome, myalgia, elevation in serum levels of skeletal-muscle enzymes, and pneumonitis.
Slovenian: Druge povezave vključujejo izpuščaj, bronhospazem, limfadenopatijo, hemolitično anemijo, vaskulitis, uveitis, angioedem, agranulocitozo, Sjögrenov sindrom, mialgijo, povišanje ravni skeletnomišičnih encimov v serumu in pnevmonitis.
English: BLISTER SLEEVE (13 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Slovenian: OVOJ PRETISNEGA OMOTA (13 trdih kapsul) - NUEDEXTA 15 mg/9 mg kapsule
English: Psychiatric disorders
Slovenian: Trombocitopenija
English: Metabolizer (PMs).
Slovenian: Povprečna Cmax.
English: Reproductive system and breast disorders General disorders and administration site conditions
Slovenian: Organski sistem Pogostnost Neželeni učinek Presnovne in prehranske motnje
English: • rash
Slovenian: • tesnoba
English: Metabolism and nutrition disorders
Slovenian: Motnje produkcije in dojk
English: Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Slovenian: Bolezni živčevja pogosti omotica, glavobol, somnolenca občasni disgevzija, hipersomnija, mišična spastičnost, sinkopa, padci redki motnje ravnotežja, nenormalna koordinacija, disartrija, motorična disfunkcija, parestezija, parapareza, sedacija
English: insomnia, restlessness, disturbed sleep
Slovenian: Očesne bolezni redki diplopija, zamegljen vid
English: Non-specific symptoms, such as light-headedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia.
Slovenian: Pred trombocitopenijo ali sočasno z njo se lahko pojavijo nespecifični simptomi, kot so omotica, mrzlica, povišana telesna temperatura, navzea in bruhanje.
English: Two of the studies lasted 6 months, and two lasted 1 year.
Slovenian: Dve od teh študij sta trajali šest mesecev, dve pa eno leto.
English: • serious infections;
Slovenian: • resne okužbe;
English: The medicine usually starts to have an effect after 4 to 6 weeks.
Slovenian: Zdravilo običajno začne učinkovati po štirih do šestih tednih.
English: The two longer studies were then extended, with patients remaining on the medicines for at least 1 more year.
Slovenian: Dve daljši študiji sta bili nato podaljšani, tako da so bolniki zdravila prejemali še vsaj eno leto.
English: These results were maintained in the extension studies.
Slovenian: Enaki rezultati so se pokazali tudi v podaljšanih študijah.
English: Further information on Leflunomide Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
Slovenian: Nadaljnje informacije o zdravilu Leflunomid Zentiva so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
English: • severe hypoproteinaemia (low blood protein levels).
Slovenian: • hudo hipoproteinemijo (nizke ravni beljakovin v krvi).
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Slovenian: • stanje hude imunske pomanjkljivosti, kot je sindrom pridobljene imunske pomanjkljivosti (aids);
English: 1 Previously known as Leflunomide Winthrop.
Slovenian: 1 Predhodno znano kot Leflunomid Winthrop.
English: Leflunomide Zentiva1 (leflunomide)
Slovenian: Leflunomid Zentiva1 (leflunomid)
English: Leflunomide Zentiva is available as tablets (10 mg, 20 mg and 100 mg).
Slovenian: Zdravilo Leflunomid Zentiva je na voljo v obliki tablet (10 mg, 20 mg in 100 mg).
English: This authorisation was based on the authorisation granted to Arava in 1999 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Arava, ki je bilo izdano leta 1999 (uporaba dokumentacije s soglasjem).
English: Leflunomide Zentiva received a marketing authorisation valid throughout the EU on 8 January 2010.
Slovenian: Za zdravilo Leflunomid Zentiva je bilo 8. januarja 2010 izdano dovoljenje za promet, veljavno po vsej EU.
English: The most common side effects with Leflunomide Zentiva (which may affect up to 1 in 10 people) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, colitis (inflammation in the large bowel), diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal (belly) pain, increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness).
Slovenian: Najpogostejši neželeni učinki zdravila Leflunomid Zentiva (ki se lahko pojavijo pri največ 1 bolniku od 10) so levkopenija (nizko število belih krvnih celic), blage alergijske reakcije, povišane ravni kreatin fosfokinaze (markerja poškodbe mišic), parestezija (nenormalen občutek zbadanja), periferna nevropatija (okvara živcev v dlaneh in stopalih), glavobol, omotica, blago povišanje krvnega tlaka, kolitis (vnetje debelega črevesa), driska, navzeja (slabost), bruhanje, vnetje v ustih, kot so razjede v ustih, bolečine v trebuhu, povišane ravni jetrnih encimov, izpadanje las, ekcem, izpuščaj, pruritus (srbečica), suha koža, tenosinovitis (vnetje ovojnice, ki obdaja kite), izguba teka, izguba telesne mase in astenija (ošibelost).
English: What measures are being taken to ensure the safe and effective use of Leflunomide Zentiva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Leflunomid Zentiva?
English: Leflunomide Zentiva must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception or during breast-feeding.
Slovenian: Zdravila Leflunomid Zentiva ne smejo uporabljati nosečnice, ženske, ki bi lahko zanosile, ter ženske, ki v obdobju dojenja ne uporabljajo zanesljivih kontracepcijskih sredstev.
English: • moderate to severely impaired kidney function;
Slovenian: • zmerno do hudo okvaro delovanja ledvic;
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Slovenian: Priporočeni vzdrževalni odmerek znaša od 10 do 20 mg enkrat na dan pri bolnikih z revmatoidnim artritisom in 20 mg enkrat na dan pri bolnikih s psoriatičnim artritisom.
English: The European Medicines Agency decided that Leflunomide Zentiva's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Leflunomid Zentiva večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Its effect may improve further for up to 6 months.
Slovenian: Nadaljnje zboljšanje njegovega učinka se lahko občuti še po šestih mesecih zdravljenja.
English: Leflunomide Zentiva must not be used in patients with:
Slovenian: Zdravila Leflunomid Zentiva ne smejo uporabljati bolniki, ki imajo:
English: As for all medicines, data on the use of Leflunomide Zentiva are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Leflunomid Zentiva stalno spremljajo.
English: Leflunomide Zentiva treatment usually starts with a ‘loading dose' of 100 mg once a day for 3 days, followed by a maintenance dose.
Slovenian: Zdravljenje z zdravilom Leflunomid Zentiva se običajno začne s „polnilnim odmerkom“ 100 mg enkrat na dan tri dni zapored, čemur sledi dajanje vzdrževalnega odmerka.
English: Over the first year of treatment, Leflunomide Zentiva was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B).
Slovenian: V prvem letu zdravljenja je bilo zdravilo Leflunomid Zentiva enako učinkovito kot metotreksat, vendar samo kadar se je jemalo v kombinaciji s folatom (vrsto vitamina B).
English: Between 49 and 55% of the patients taking Leflunomide Zentiva responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine.
Slovenian: Na zdravljenje se je odzvalo od 49 % do 55 % bolnikov, ki so jemali zdravilo Leflunomid Zentiva, v primerjavi s 26 % do 28 % bolnikov, ki so jemali placebo, in 54 % tistih, ki so prejemali sulfasalazin.
English: Doctors prescribing Leflunomide Zentiva need to be aware of the risk of liver problems associated with the medicine.
Slovenian: Zdravniki, ki predpisujejo zdravilo Leflunomid Zentiva, se morajo zavedati tveganja težav z jetri, povezanih z zdravilom.
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;
Slovenian: • poslabšano funkcijo kostnega mozga ali nizko število krvnih celic (rdečih krvničk, belih krvničk ali trombocitov), ki jo povzročajo druga obolenja, razen revmatoidnega ali psoriatičnega artritisa;
English: • liver disease;
Slovenian: • bolezen jeter;
English: Results showed that Leflunomide Zentiva was more effective than placebo and as effective as sulphasalazine.
Slovenian: Rezultati so pokazali, da je zdravilo Leflunomid Zentiva učinkovitejše od placeba in enako učinkovito kot sulfasalazin.
English: The company that markets Leflunomide Zentiva will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Leflunomide Zentiva and the monitoring that should be carried out in patients.
Slovenian: Podjetje, ki trži zdravilo Leflunomid Zentiva, bo zagotovilo, da bodo zdravniki, ki naj bi predpisovali zdravilo, prejeli informativno gradivo s pomembnimi informacijami o tveganjih, povezanih z zdravilom Leflunomid Zentiva, in o spremljanju, ki ga je treba izvajati pri bolnikih.
English: What benefits of Leflunomide Zentiva have been shown in the studies?
Slovenian: Kakšne koristi zdravila Leflunomid Zentiva so se pokazale v študijah?
English: In psoriatic arthritis, a study in 186 patients showed that Leflunomide Zentiva was more effective than placebo over 6 months: 59% of the patients taking Leflunomide Zentiva responded to treatment, compared with 30% of those taking placebo.
Slovenian: Študija psoriatičnega artritisa, v kateri je sodelovalo 186 bolnikov, je pokazala, da je bilo zdravilo Leflunomid Zentiva v šestih mesecih učinkovitejše od placeba: na zdravljenje se je odzvalo 59 % bolnikov, ki so jemali zdravilo Leflunomid Zentiva, v primerjavi s 30 % bolnikov, ki so jemali placebo.
English: The active substance in Leflunomide Zentiva, leflunomide, is an immunosuppressant.
Slovenian: Učinkovina v zdravilu Leflunomid Zentiva, leflunomid, je imunosupresiv.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Leflunomide Zentiva have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Leflunomid Zentiva upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Leflunomide Zentiva is a medicine used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Slovenian: Leflunomid Zentiva je zdravilo, ki se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča rdeče, luskaste zaplate na koži in vnetje sklepov).
English: Side effects reported with Leflunomide Zentiva are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Leflunomid Zentiva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Leflunomide Zentiva authorised in the EU?
Slovenian: Zakaj je zdravilo Leflunomid Zentiva odobreno v EU?
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega in psoriatičnega artritisa.
English: An overview of Leflunomide Zentiva and why it is authorised in the EU
Slovenian: Pregled zdravila Leflunomid Zentiva in zakaj je odobreno v EU
English: For more information about using Leflunomide Zentiva, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij o uporabi zdravila Leflunomid Zentiva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.