natgillin/translations-raw huggingface dataset:
For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Previdnost je potrebna tudi v primeru sočasne uporabe drugih substratov BCRP (npr. metotreksata, topotekana, sulfasalazina, daunorubicina, doksorubicina) in družine OATP, zlasti zaviralcev HMG-CoA-reduktaze (npr. simvastatina, atorvastatina, pravastatina, metotreksata, nateglinida, repaglinida, rifampicina).
Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Zato je treba pri bolnikih, ki se zdravijo z leflunomidom ali teriflunomidom, podvomiti o verodostojnosti opaženih znižanih ravni ioniziranega kalcija.
What you need to know before you take Leflunomide Zentiva Do not take Leflunomide Zentiva
Kaj morate vedeti preden boste vzeli zdravilo Leflunomid Zentiva
Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n=498).
V študiji MN302 so 999 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 501) ali metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 498).
Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
V študiji US301 so 482 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 182), metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 182) ali placebo (n = 118).
Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92).
V študiji MN301 so 358 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 133), sulfasalazin 2 g/dan (n = 133) ali placebo (n = 92).
What Leflunomide Zentiva looks like and contents of the pack
Izgled zdravila Leflunomid Zentiva in vsebina pakiranja
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria
zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
6.1 Seznam pomožnih snovi
Leflunomide Zentiva with food, drink and alcohol
Zdravilo Leflunomid Zentiva skupaj s hrano, pijačo in alkoholom Zdravilo Leflunomid Zentiva lahko jemljete s hrano ali brez nje.
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni
Date of first authorisation: 08 January 2010 Date of latest renewal: 08 January 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve registracije: 02 januar 2010
Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Občasno lahko zdravilo Leflunomid Zentiva povzroči nekatere krvne, jetrne, pljučne težave ali težave z živci v rokah in nogah.
PHARMACEUTICAL FORM
FARMAKOLOŠKE LASTNOSTI
Excipients with known effect Each tablet contains 78 mg of lactose monohydrate.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 78 mg laktoze monohidrata.
renal failure
Okvara ledvic
Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Občasno lahko zdravilo Leflunomid Zentiva povzroči nekatere krvne, jetrne,pljučne težave ali težave z živci v rokah in nogah .
Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Pomožne snovi z znanim učinkom Ena tableta vsebuje 72 mg laktoze monohidrata.
Leflunomide Zentiva contains lactose.
Zdravilo Leflunomid Zentiva vsebuje laktozo.
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Filmska obloga: smukec (E553b) hipromeloza (E464) titanov dioksid (E171) makrogol 8000
Crospovidone (E1202) Talc (E553b)
Jedro tablete: koruzni škrob povidon (E1201) krospovidon (E1202) smukec (553b)
30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 50 filmsko obloženih tablet 100 filmsko obloženih tablet
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.
colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
kolitis, vključno z mikroskopskim kolitisom, kot je na primer limfocitni kolitis, kolagenski kolitis, driska, navzeja, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu
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 an unknown frequency.
Pojavijo se lahko tudi drugi neželeni učinki, katerih pogostnost ni znana, kot so 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.
Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Pustular psoriasis and worsening of psoriasis have been reported after the use of leflunomide.
Po jemanju leflunomida so poročali o posturalni psoriazi in njenem poslabšanju.
Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Jedro tablete: koruzni škrob povidon (E1201) krospovidon (E1202) brezvodni koloidni silicijev dioksid magnezijev stearat (E470b) laktoza monohidrat
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side.
Rumenkasta do okrasta, trikotna filmsko obložena tableta, z napisom ZBO na eni strani.
Blister:
Plastenka:
- 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.
Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver.
Leflunomid se že med presnovo prvega prehoda v črevesni steni in jetrih hitro pretvori (z odprtjem obroča) v aktivni presnovek A771726.
Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Tveganje za resne neželene učinke lahko poleg tega poveča tudi prehod z leflunomida na drugo imunomodulirajoče protirevmatično zdravilo brez postopka izpiranja (glejte poglavje 4.4), in to celo dalj časa po prehodu.
It is not recommended to drink alcohol during treatment with Leflunomide Zentiva.
Med zdravljenjem z zdravilom Leflunomid Zentiva ni priporočljivo pitje alkohola.
cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Uporaba nekaterih imunosupresivnih zdravil poveča nevarnost malignomov, zlasti limfoproliferativnih bolezni.
Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare:
anemija, blaga trombocitopenija (trombociti < 100 x 109/l)
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
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); izmanjšanje števila vseh krvnih celic (pancitopenija).
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20 kg, 20-40 kg, and >40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02).
Po 16 tednih zdravljenja je bila razlika v deležu odziva statistično značilna v prid metotreksata po opredelitvi izboljšanja (DOI - Definition of Improvement) za JRA ≥ 30 % (p = 0,02).
In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
zdravih prostovoljcih v plazmi, urinu ali blatu niso našli nespremenjenega leflunomida.
Medicinal product subject to medical prescription.
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
Film-coated tablet.
FARMACEVTSKA OBLIKA filmsko obložena tableta
Human pharmacology
Farmakologija pri ljudeh
In either case the A771726 plasma concentration is then measured for the first time.
V obeh primerih se nato prvič izmeri plazemska koncentracija A771726.
Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide.
Med zdravljenjem z leflunomidom so opisani redki primeri hude okvare jeter, tudi s smrtnim izidom.
There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Med sočasno uporabo leflunomida in varfarina so opisani primeri podaljšanja protrombinskega časa.
Therefore, monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.
Med uporabo zdravil, ki se presnavljajo s CYP2C8 (npr. repaglinid, paklitaksel, pioglitazon ali rosiglitazon), je izpostavljenost lahko večja, zato je bolnike, ki prejemajo takšna zdravila, priporočljivo kontrolirati.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide Zentiva.
Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid Zentiva je treba upoštevati dolg razpolovni čas leflunomida.
However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Toda med sočasno uporabo A771726 in varfarina se je največja vrednost internacionalnega normaliziranega razmerja (INR) v primerjavi z uporabo samega varfarina zmanjšala za 25 %.
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, anoreksija, izguba telesne mase (ponavadi nepomembno), astenija, blage alergijske reakcije in zvišanje jetrnih parametrov (transaminaze (zlasti ALT), manj pogosto gama-GT, alkalne fosfataze, bilirubina).
Respiratory reactions
Reakcije dihal
Washout procedure
Postopek izpiranja
Leflunomide Zentiva contains lactose
Zdravilo Leflunomid Zentiva vsebuje laktozo
Skin and subcutaneous tissue disorders Common:
Bolezni kože in podkožja Pogosti:
Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Pri bolnikih, ki so jemali zdravilo Leflunomid Zentiva, so poročali o primerih periferne nevropatije.
Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Leflunomid Zentiva 20 mg filmsko obložene tablete so rumenkaste do okraste barve in trikotne oblike.
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)
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,
Colestyramine 8 g is administered 3 times daily.
Trikrat na dan se daje po 8 g holestiramina.
pulmonary hypertension Gastrointestinal disorders Common:
pljučna hipertenzija Bolezni prebavil Pogosti:
Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Pri bolnikih, zdravljenih z leflunomidom, so poročali o kolitisu, vključno z mikroskopskim kolitisom.
General disorders and administration site conditions Common:
Splošne težave in spremembe na mestu aplikacije Pogosti:
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
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).
- 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).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila Leflunomid Zentiva, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
hypouricemia Psychiatric disorders Uncommon: anxiety Nervous system disorders Common:
hipourikemija Psihiatrične motnje Občasni:
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies
V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/dan v primerjavi s placebom 54,6 % proti 28,6 % (študija MN301) in 49,4 % proti 26,3 % (študija US301).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PRETISNI OMOT
Leflunomide Zentiva 20 mg
PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 20 mg
The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.
Vendar pa je bila incidenca gastrointestinalnih neželenih učinkov in zvišanih jetrnih encimov nekoliko večja pri bolnikih, ki so prejeli začetni odmerek 100 mg leflunomida.
Each film-coated tablet contains 20 mg leflunomide.
Vsaka filmsko obložena tableta vsebuje 20 mg leflunomida.
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo.
Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax repaglinida za 1,7-krat in njegove povprečne AUC za 2,4-krat; to kaže, da A771726 in vivo zavira CYP2C8.
Management
Ukrepanje
- 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.
Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov) zmanjšanje števila rdečih krvnih celic (anemija) in zmanjšanje števila krvnih ploščic (trombocitopenija), zmanjšanje koncentracije kalija v krvi, tesnobnost, motnje okusa, pojav koprivnice, pretrganje tetive, zvečanje koncentracije maščob v krvi (holesterola in trigliceridov), zmanjšanje koncentracije fosfata v krvi.
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b), 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 film-coating.
- Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), smukec (E553b), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
30 film-coated tablets 100 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 100 filmsko obloženih tablet
- 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,
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),
Each film-coated tablet contains 10 mg leflunomide.
Vsaka filmsko obložena tableta vsebuje 10 mg leflunomida.
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Ne jemljite zdravila Leflunomid Zentiva - 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,
Leflunomide Zentiva 10 mg
PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 10 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
A771726.
Zaradi zelo dolgega razpolovnega časa A771726
- 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 film-coating.
- 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) in makrogol 8000 v filmski oblogi.
Each film-coated tablet contains 100 mg leflunomide.
Vsaka filmsko obložena tableta vsebuje 100 mg leflunomida.
Leflunomide Zentiva 100 mg
PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 100 mg