natgillin/translations-raw huggingface dataset:
Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Dekstrometorfan / kinidin nije ispitivan u bolesnika s teškim oštećenjem funkcije bubrega.
• abnormally frequent daytime urination
• abnormalno učestalo mokrenje tijekom dana
Paroxetine (CYP2D6 inhibitor and substrate)
Paroksetin (inhibitor i supstrat CYP2D6)
Desipramine (CYP2D6 substrate)
Desipramin (supstrat CYP2D6)
A population pharmacokinetic analysis of 170 subjects (148 subjects <65 years old and 22 subjects ≥65 years old) administered dextromethorphan 23 mg / quinidine 26 mg revealed similar pharmacokinetics in subjects <65 years and those ≥65 years of age.
≥65 godina) koji su primali dekstrometorfan 23 mg / kinidin 26 mg, otkrila je sličnu farmakokinetiku u ispitanika <65 godina i onih ≥65 godina.
Concomitant medicinal products that both prolong the QT interval and are primarily metabolised by CYP2D6 (see below) are of particular potential concern.
Osobitu potencijalnu važnost imaju lijekovi koji se istovremeno uzimaju, a produljuju QT interval, a ujedno se metaboliziraju putem CYP2D6 (vidjeti niže).
Regardless of which strength of NUEDEXTA has been prescribed to you: • continue the treatment with: two capsules per day (one capsule every 12 hours).
Bez obzira koja Vam je jačina lijeka NUEDEXTA propisana: • nastavite s terapijom:
CYP2D6 substrates
Supstrati CYP2D6
How to store NUEDEXTA
Kako čuvati lijek NUEDEXTA
• abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
• neuobičajena stolica, loša probava, upala sluznice želuca (gastritis), utrnulost i poremećen osjet u ustima, bol završnog dijela debelog crijeva, suh jezik
Concomitant use of CYP2D6 substrates/inhibitors
Istovremena uporaba supstrata / inhibitora CYP2D6
Strong and moderate CYP3A4 inhibitors should be avoided during treatment with NUEDEXTA.
Za vrijeme terapije NUEDEXTOM potrebno je izbjegavati snažne i umjerene inhibitore CYP3A4.
Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Simptomi serotoninskog sindroma uključuju tjelesnu i psihičku uznemirenost (agitacija), visoki krvni tlak, nemir, mišićne grčeve i trzaje, visoku tjelesnu temperaturu, prekomjerno znojenje, tresavicu i nevoljno drhtanje.
• teeth grinding (bruxism), confusion, depressed mood, depression, disorientation (e.g. difficulty sensing time, direction, and recognition of people and places), early morning awakening,
• škripanje zubima (bruksizam), smetenost, depresivno raspoloženje, depresija, dezorijentiranost (npr. teškoće s osjećajem za vrijeme, smjer i prepoznavanje osoba i mjesta), rano jutarnje buđenje, smanjena emocionalna ekspresivnost (zaravnjeni afekt), halucinacije, impulzivno ponašanje, ravnodušnost, nesanica, nemir, poremećeno spavanje
BLISTER SLEEVE (13 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
OMOT BLISTERA (13 tvrdih kapsula) - NUEDEXTA 15 mg/9 mg kapsule
Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, increased heart rate, hyperexcitability, and toxic psychosis.
Simptomi predoziranja dekstrometorfanom uključuju mučninu, povraćanje, stupor (ošamućenost), komu, depresiju disanja, napadaje, povećanu brzinu srčanih otkucaja, pretjeranu razdražljivost (hiperekscitabilnost) i toksičku psihozu.
Adverse reactions of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis.
Nuspojave zbog predoziranja dekstrometorfanom uključuju mučninu, povraćanje, stupor, komu, depresiju disanja, napadaje, tahikardiju, hiperekscitabilnost i toksičku psihozu.
NUEDEXTA 15 mg/9 mg hard capsules NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
NUEDEXTA 15 mg/9 mg tvrde kapsule NUEDEXTA 23 mg/9 mg tvrde kapsule dekstrometorfan/kinidin
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.
Ispitivanje interakcije lijekova provedeno je između više kombinirane doze dekstrometorfana / kinidina (dekstrometorfan 23 mg / kinidin 26 mg) i memantina 20 mg na dan.
A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and desipramine 25 mg.
Ispitivanje interakcije lijekova provedeno je između više kombinirane doze dekstrometorfana / kinidina (dekstrometorfan 23 mg / kinidin 26 mg) i desipramina 25 mg.
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Each bottle is packed in a carton.
Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu.
Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Prilagodba doze nije potrebna u bolesnika s povećanom aktivnošću enzima CYPD2D6, koji se nazivaju ultrabrzi metabolizatori, vidjeti dio 5.2. U slučaju neodgovarajućeg kliničkog odgovora, vidjeti preporučeni raspored titracije doze.
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.
Za dijagnozu je bitna prisutnost temeljne neurološke bolesti za koju je poznato da može uzrokovati pojavu pseudobulbarnog afekta, te potvrda da su epizode emocionalne ekspresije u raskoraku ili nerazmjeru s bolesnikovim emocionalnim stanjem ili raspoloženjem.
Dextromethorphan
Dekstrometorfan
Reproductive system and breast disorders General disorders and administration site conditions
Poremećaji bubrega i mokraćnog sustava Poremećaji reproduktivnog sustava i dojki
MARKETING AUTHORISATION NUMBER(S)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET)
Common Diarrhoea, Nausea Abdominal pain, Constipation, Dry mouth, Flatulence, Stomach discomfort, Vomiting
Manje često bol u trbuhu, konstipacija, suha usta, flatulencija, nelagoda u trbuhu, povraćanje
- If you get any side effects, talk to your doctor or pharmacist.
- Ako Vam se pojavi bilo kakva nuspojava, obratite se liječniku ili ljekarniku.
The maximum mean (95% upper confidence bound) differences from placebo after baseline-correction were 10.2 (14.6) and 18.4 (22.7) ms following dextromethorphan/quinidine doses of 23 mg /26 mg and 46 mg /53 mg, respectively.
Nakon doza dekstrometorfana / kinidina od 23 mg / 26 mg i 46 mg / 53 mg, maksimalne srednje vrijednosti razlika (95% gornje granice pouzdanosti) u odnosu na placebo iznosile su nakon korekcije početnih vrijednosti 10,2 (14,6) odnosno 18,4 (22,7) ms.
NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
NUEDEXTA 23 mg/9 mg tvrde kapsule dekstrometorfan / kinidin
Chest discomfort, Chest pain, Chills, Feeling hot, Gait disturbance, Influenza like illness, Pyrexia, Oxygen
Manje često astenija, razdražljivost nelagoda u prsima, bol u prsima, zimica, osjećaj vrućine, poremećen hod, bolest nalik gripi, vrućica, smanjena zasićenost kisikom
• uncommon (≥1/1,000 to <1/100)
• manje često (≥1/1000 i <1/100)
• if you are already taking medicines containing quinidine, quinine, or mefloquine.
• ako već uzimate lijekove koji sadrže kinidin, kinin ili meflokin; to su lijekovi za liječenje malarije ili tegoba sa srčanim ritmom.
If you get any side effects, talk to your doctor or pharmacist.
Ako Vam se pojavi bilo kakva nuspojava, obratite se liječniku ili ljekarniku.
Driving and using machines NUEDEXTA may cause dizziness.
NUEDEXTA može prouzročiti omaglicu.
Your doctor will monitor you closely for signs of NUEDEXTA misuse or abuse.
Liječnik će pažljivo nadzirati moguću pojavu znakova pogrešne primjene ili zlouporabe lijeka NUEDEXTA.
• abdominal pain, constipation, dry mouth, wind (flatulence), stomach discomfort, vomiting
• bol u trbuhu, zatvor (konstipacija), suha usta, vjetrovi (flatulencija), nelagoda u trbuhu,
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.
Druge povezane nuspojave uključuju osip, bronhospazam, limfadenopatiju, hemolitičku anemiju, vaskulitis, uveitis, angioedem, agranulocitozu, sindrom sicca, mialgiju, povišenje serumskih razina koštano-mišićnih enzima i pneumonitis.
NUEDEXTA 15 mg/9 mg hard capsules dextromethorphan / quinidine
NUEDEXTA 15 mg/9 mg tvrde kapsule dekstrometorfan / kinidin
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.
Jedna kapsula lijeka NUEDEXTA 15 mg/9 mg sadrži 15,41 mg dekstrometorfana u obliku dekstrometorfan hidrobromid monohidrata i 8,69 mg kinidina u obliku kinidinsulfat dihidrata.
MAOIs
Omaglica
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.
Jedna kapsula lijeka NUEDEXTA 23 mg/9 mg sadrži 23,11 mg dekstrometorfana u obliku dekstrometorfan hidrobromid monohidrata i 8,69 mg kinidina u obliku kinidinsulfat dihidrata.
• diarrhoea, nausea
• proljev, mučnina
Thrombocytopenia
• tjeskoba
BOTTLE LABEL (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
NALJEPNICA NA BOČICI (60 tvrdih kapsula) - NUEDEXTA 23 mg/9 mg kapsule
BOTTLE CARTON (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
KUTIJA ZA BOČICU (60 tvrdih kapsula) - NUEDEXTA 23 mg/9 mg kapsule
• NUEDEXTA 15 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
• NUEDEXTA 15 mg/9 mg želatinska je kapsula ciglasto-crvene boje, veličine 1, s oznakom
BOTTLE LABEL (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
NALJEPNICA NA BOČICI (60 tvrdih kapsula) - NUEDEXTA 15 mg/9 mg kapsule
Musculoskeletal stiffness, Myalgia, Neck pain, Pain in
Manje često mišićni grčevi mišićno-koštana ukočenost, mialgija, bol u vratu, bol u
Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Jedna kapsula sadrži 23,11 mg dekstrometorfana u obliku dekstrometorfan hidrobromid monohidrata i 8,69 mg kinidina u obliku kinidinsulfat dihidrata.
Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Jedna kapsula sadrži 15,41 mg dekstrometorfana u obliku dekstrometorfan hidrobromid monohidrata i 8,69 mg kinidina u obliku kinidinsulfat dihidrata.
BOTTLE CARTON (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
KUTIJA ZA BOČICU (60 tvrdih kapsula) - NUEDEXTA 15 mg/9 mg kapsule
• chest discomfort, chest pain, chills, feeling hot, gait disturbance (difficulty walking), flu-like illness, fever, decreased oxygen levels in the blood
bolest nalik gripi, vrućica, smanjene razine kisika u krvi
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.
U ispitivanju interakcija lijekova, paroksetinu je u stanju dinamičke ravnoteže dodana viša kombinirana doza dekstrometorfana / kinidina (dekstrometorfan 23 mg / kinidin 26 mg).
• fatigue
• umor
• NUEDEXTA 23 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
• NUEDEXTA 23 mg/9 mg želatinska je kapsula ciglasto-crvene boje, veličine 1, s oznakom
• 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
Rijetko nenormalna stolica. dispepsija, gastritis, oralna hipoestezija, oralna parestezija, proktalgija, suhoća jezika
Skeletal injury
• mišićni grčevi
Non-specific symptoms, such as light-headedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia.
Trombocitopeniji mogu prethoditi, ili se uz nju mogu pojaviti, nespecifični simptomi kao što su ošamućenost, zimica, vrućica, mučnina i povraćanje.
Two of the studies lasted 6 months, and two lasted 1 year.
Dva su ispitivanja trajala šest mjeseci, a dva su trajala godinu dana.
• serious infections;
• ozbiljnim infekcijama
This authorisation was based on the authorisation granted to Arava in 1999 (‘informed consent').
Odobrenje se temeljilo na odobrenju koje je 1999. izdano za lijek Arava („informirani pristanak”).
The medicine usually starts to have an effect after 4 to 6 weeks.
Djelovanje lijeka obično započinje nakon četiri do šest tjedana.
Its effect may improve further for up to 6 months.
Njegov učinak može se dodatno poboljšati tijekom sljedećih šest mjeseci.
These results were maintained in the extension studies.
Isti su se rezultati zadržali tijekom produženih ispitivanja.
Further information on Leflunomide Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
Više informacija o lijeku Leflunomide Zentiva nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
Leflunomide Zentiva1 (leflunomide)
Leflunomide Zentiva1 (leflunomid)
The two longer studies were then extended, with patients remaining on the medicines for at least 1 more year.
Dva duža ispitivanja produžena su, pri čemu su bolesnici nastavili primati lijekove još najmanje godinu dana.
1 Previously known as Leflunomide Winthrop.
1 Prethodno poznat pod nazivom Leflunomide Winthrop.
Leflunomide Zentiva is available as tablets (10 mg, 20 mg and 100 mg).
Lijek Leflunomide Zentiva dostupan je u obliku tableta (10 mg, 20 mg i 100 mg).
• severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
• teškim stanjem imunodeficijencije, kao što je sindrom stečene imunodeficijencije (AIDS)
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.
Leflunomide Zentiva ne smije se davati trudnicama, ženama koje mogu zatrudnjeti ili ne primjenjuju pouzdanu kontracepciju kao ni tijekom dojenja.
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).
Najčešće su nuspojave lijeka Leflunomide Zentiva (koje se mogu javiti u najviše 1 od 10 osoba) leukopenija (niska razina bijelih krvnih stanica), blage alergijske reakcije, povišena razina kreatina fosfokinaze (pokazatelja mišićnog oštećenja), parestezija (neobičan osjećaj poput trnaca i probadanja), periferna neuropatija (oštećenje živaca u šakama i stopalima), glavobolja, omaglica, blago povišenje krvnog tlaka, kolitis (upala debelog crijeva), proljev, mučnina, povraćanje, upalne promjene u usnoj šupljini poput afti, abdominalni bol (bol u trbuhu), povišena razina jetrenih enzima, gubitak kose, ekcem, osip, pruritus (svrbež), suha koža, tenosinovitis (upala ovojnice tetiva), gubitak apetita, gubitak težine i astenija (slabost).
• severe hypoproteinaemia (low blood protein levels).
• teškom hipoproteinemijom (niskom razinom proteina u krvi).
Leflunomide Zentiva treatment usually starts with a ‘loading dose' of 100 mg once a day for 3 days, followed by a maintenance dose.
Liječenje lijekom Leflunomide Zentiva obično započinje „udarnom dozom” od 100 mg jednom dnevno tijekom tri dana, nakon čega slijedi doza održavanja.
Leflunomide Zentiva received a marketing authorisation valid throughout the EU on 8 January 2010.
Za lijek Leflunomide Zentiva izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 8. siječnja 2010.
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.
Između 49 i 55 % bolesnika koji su primali lijek Leflunomide Zentiva odgovorilo je na liječenje, u usporedbi s 26 do 28 % onih koji su primali placebo i 54 % onih koji su primali sulfasalazin.
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).
Tijekom prve godine terapije lijek Leflunomide Zentiva bio je jednako učinkovit kao i metotreksat, ali samo kada se uzimao s folatom (vrstom vitamina B).
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.
Preporučena doza održavanja je 10 do 20 mg jednom dnevno za bolesnike s reumatoidnim artritisom te 20 mg jednom dnevno za bolesnike s psorijatičnim artritisom.
Results showed that Leflunomide Zentiva was more effective than placebo and as effective as sulphasalazine.
Rezultati su pokazali da je lijek Leflunomide Zentiva učinkovitiji od placeba i jednako učinkovit kao i sulfasalazin.
What measures are being taken to ensure the safe and effective use of Leflunomide Zentiva?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Leflunomide Zentiva?
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.
Izdaje se samo na liječnički recept, a liječenje mora započeti i nadzirati specijalist s iskustvom u liječenju reumatoidnog artritisa i psorijatičnog artritisa.
Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Leflunomid to čini blokirajući enzim dihidroorotat dehidrogenazu koji je potreban za razmnožavanje limfocita.
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.
U slučaju psorijatičnog artritisa, ispitivanje provedeno na 186 bolesnika pokazalo je da je lijek Leflunomide Zentiva učinkovitiji od placeba tijekom šest mjeseci: 59 % bolesnika koji su primali lijek Leflunomide Zentiva odgovorilo je na liječenje, u usporedbi s 30 % onih koji su primali placebo.
It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Ublažuje upalu smanjujući proizvodnju imunosnih stanica koje se nazivaju limfociti i odgovorne su za upalu.
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Smanjenje broja limfocita ublažava upalu, što pomaže pri kontroli simptoma artritisa.
Leflunomide Zentiva must not be used in patients with:
Leflunomide Zentiva ne smije se koristiti u osoba s(a):
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).
Leflunomide Zentiva primjenjuje se za liječenje odraslih osoba s aktivnim reumatoidnim artritisom (bolesti imunosnog sustava koja uzrokuje upalu zglobova) ili aktivnim psorijatičnim artritisom (bolesti koja uzrokuje crvene, ljuskave mrlje na koži i upalu zglobova).
Side effects reported with Leflunomide Zentiva are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Leflunomide Zentiva pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
• moderate to severely impaired kidney function;
• umjerenim ili teškim oštećenjem bubrežne funkcije
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.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Leflunomide Zentiva nalaze se u sažetku opisa svojstava i u uputi o lijeku.
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.
Tvrtka koja stavlja na tržište lijek Leflunomide Zentiva osigurat će da liječnici za koje se očekuje da će propisivati lijek dobiju informativni paket koji sadržava važne podatke o rizicima povezanima s lijekom Leflunomide Zentiva i o praćenju bolesnika.
The active substance in Leflunomide Zentiva, leflunomide, is an immunosuppressant.
Djelatna tvar lijeka Leflunomide Zentiva, leflunomid, pripada skupini imunosupresiva.
As for all medicines, data on the use of Leflunomide Zentiva are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Leflunomide Zentiva kontinuirano se prate.
Doctors prescribing Leflunomide Zentiva need to be aware of the risk of liver problems associated with the medicine.
Liječnici koji propisuju lijek Leflunomide Zentiva trebaju biti svjesni rizika od problema s jetrenom funkcijom koji su povezani s lijekom.
An overview of Leflunomide Zentiva and why it is authorised in the EU
Pregled informacija o lijeku Leflunomide Zentiva i zašto je odobren u EU-u
What is Leflunomide Zentiva and what is it used for?
Što je Leflunomide Zentiva i za što se primjenjuje?
Other information about Leflunomide Zentiva
Ostale informacije o lijeku Leflunomide Zentiva
Leflunomide Zentiva was not as effective as methotrexate in the extension study.
Lijek Leflunomide Zentiva pokazao se manje učinkovitim od metotreksata u produženom ispitivanju.
In rheumatoid arthritis, Leflunomide Zentiva has been studied in 4 main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis).
U slučaju reumatoidnog artritisa, lijek Leflunomide Zentiva ispitan je u četirima glavnim ispitivanjima kojima je bilo obuhvaćeno 2 000 bolesnika, pri čemu je uspoređen s placebom (prividnim liječenjem) odnosno metotreksatom ili sulfasalazinom (drugim lijekovima kojima se liječi reumatoidni artritis).
The medicine contains the active substance leflunomide.
Lijek sadržava djelatnu tvar leflunomid.
Why is Leflunomide Zentiva authorised in the EU?
Zašto je lijek Leflunomide Zentiva odobren u EU-u?
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.
Europska agencija za lijekove zaključila je da koristi od lijeka Leflunomide Zentiva nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
What are the risks associated with Leflunomide Zentiva?
Koji su rizici povezani s lijekom Leflunomide Zentiva?