FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the long half-life of natalizumab, concomitant exposure, and thus concomitant immune effects, could occur for up to 2-3 months following discontinuation of natalizumab if AUBAGIO was immediately started.
Slovenian: Če po prekinitvi zdravljenja z natalizumabom nemudoma začnete z dajanjem zdravila AUBAGIO, lahko zaradi dolge razpolovne dobe natalizumaba do sočasne izpostavljenosti in s tem sočasnih imunskih učinkov prihaja do 2-3 mesece po prekinitvi zdravljenja z natalizumabom.
English: The primary biotransformation pathway for teriflunomide is hydrolysis with oxidation being a minor pathway.
Slovenian: Primarna pot biotransformacije teriflunomida je hidroliza, manj pomembna presnovna pot je oksidacija.
English: Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following repeated oral administration of teriflunomide, with high bioavailability (approximately 100%).
Slovenian: Mediana časa do najvišjih plazemskih koncentracij je od 1 do 4 ur po odmerku pri ponavljajočem se peroralnem odmerjanju teriflunomida.
English: Teriflunomide is excreted in the gastrointestinal tract mainly through the bile as unchanged medicinal product and most likely by direct secretion.
Slovenian: Teriflunomid se izloča v prebavila v glavnem z žolčem v nespremenjeni obliki, najverjetneje z neposrednim izločanjem.
English: AUBAGIO 14 mg tablets teriflunomide
Slovenian: AUBAGIO 14 mg tablete teriflunomid
English: In particular, tell your doctor or pharmacist if you are taking any of the following: - leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators) - rifampicin (a medicine used to treat tuberculosis and other infections) - carbamazepine, phenobarbital, phenytoin for epilepsy - St John's wort (a herbal medicine for depression) - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinenece or in kidney disease in diabetics - alosetron for the management of severe diarrhea - theophylline for asthma - tizanidine, a muscle relaxant - warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots - oral contraceptives (containing ethinylestradiol and levonorgestrel)
Slovenian: Zdravniku ali farmacevtu morate obvezno povedati, če jemljete katerega od naslednjih zdravil: - leflunomid, metotreksat ali druga zdravila, ki vplivajo na imunski sistem (pogosto jim pravimo imunosupresivna zdravila ali imunomodulatorji), - rifampicin (zdravilo, ki se uporablja za zdravljenje tuberkuloze in drugih okužb), - karbamazepin, fenobarbital, fenitoin za epilepsijo, - šentjanževko (zeliščno zdravilo za depresijo), - repaglinid, pioglitazon, nateglinid ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel ali topotekan za zdravljenje raka, - duloksetin za depresijo, urinsko inkontinenco ali pri ledvični bolezni pri diabetikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - varfarin, antikoagulacijsko zdravilo za redčenje krvi, ki preprečuje nastajanje krvnih strdkov,
English: Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in teriflunomide-treated groups as compared to placebo.
Slovenian: Blago zvišanje ravni transaminaz, ALT nižji ali enak 3-kratniku zgornje meje normalnih vrednosti (ULNUpper limit of Normal), so pogosteje ugotovili pri bolnikih, ki so prejemali teriflunomid, kot pri bolnikih, ki so prejemali placebo.
English: In cases of severe haematological reactions, including pancytopenia, AUBAGIO and any concomitant myelosuppressive treatment must be discontinued and a teriflunomide accelerated elimination procedure should be considered.
Slovenian: V primerih hudih hematoloških reakcij, vključno s pancitopenijo, je treba prekiniti zdravljenje z zdravilom AUBAGIO in vsa sočasna mielosupresivna zdravljenja.
English: AUBAGIO is taken every day as a single daily dose at any time of the day.
Slovenian: Zdravilo AUBAGIO jemljete vsak dan.
English: Severe renal impairment had no impact on the pharmacokinetic of teriflunomide.
Slovenian: Huda okvara ledvic ni vplivala na farmakokinetiko teriflunomida.
English: Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.
Slovenian: Pri bolnikih s hudo aktivno okužbo je treba zdravljenje s teriflunomidom odložiti do resolucije.
English: Change relative to placebo (CI95%) Number of unique active lesions /scan Change relative to placebo (CI95%)  p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo (1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml
Slovenian:  p < 0,0001  p < 0,001  p < 0,01  p < 0,05 v primerjavi s placebom
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared with warfarin alone.
Slovenian: Vendar so pri sočasnem jemanju teriflunomida in varfarina ugotovili 25-odstotno znižanje vrha internacionalnega normaliziranega razmerja (INR) v primerjavi z jemanjem varfarina samega.
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration of teriflunomide should also be undertaken with caution.
Slovenian: Pri drugih substratih BCRP (npr. metotreksatu, topotekanu, sulfasalazinu, daunorubicinu, doksorubicinu) in družine OATP, zlasti zaviralcih HMG-Coreduktaze, je potrebna previdnost pri sočasni uporabi s teriflunomidom.
English: - you take leflunomide with AUBAGIO.
Slovenian: - če ob zdravilu AUBAGIO jemljete tudi leflunomid.
English: Severe skin reactionsa, Psoriasis (including pustular)b
Slovenian: Bolezni kože in podkožja alopecija izpuščaj, akne bolezni nohtov hude kožne reakcijea, psoriaza (vključno s pustulozno psoriazo)b
English: Uncommon (may affect up to 1 in 100 people) - Decrease in the number of blood platelets (mild thrombocytopenia) - Increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy) - Nail disorders - Post-traumatic pain
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 uporabnikov) - zmanjšanje števila krvnih ploščic (blaga trombocitopenija), - povečano čutenje ali občutljivost, zlasti kože; ostra ali utripajoča bolečina vzdolž enega ali več živcev,
English: In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed in patients treated with teriflunomide compared to placebo.
Slovenian: V s placebom kontroliranih študijah so pri bolnikih, ki so prejemali teriflunomid, ugotovili povprečno znižanje serumske sečne kisline v razponu od 20 do 30 %.
English: Teriflunomide is contraindicated in this population (see section 4.3).
Slovenian: Teriflunomid je v tej populaciji kontraindiciran (glejte poglavje 4.3).
English: - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
Slovenian: - peroralna kontracepcijska sredstva (ki vsebujejo etinilestradiol in levonorgestrel), - cefaklor, benzilpenicilin (penicilin G), ciprofloksacin za zdravljenje okužb, - indometacin, ketoprofen za bolečine ali vnetja, - furosemid za srčno bolezen, - cimetidin za zmanjšanje izločanja želodčne kisline, - zidovudin za okužbo z virusom HIV, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (visok holesterol), - sulfasalazin za kronično vnetno črevesno bolezen in revmatoidni artritis, - holestiramin za povišan holesterol ali lajšanje srbenja pri bolezni jeter, - aktivno oglje za zmanjšanje absorpcije zdravil ali drugih snovi.
English: What you need to know before you take AUBAGIO Do not take AUBAGIO:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo AUBAGIO
English: How to store AUBAGIO 6.
Slovenian: Shranjevanje zdravila AUBAGIO 6.
English: Do not stop taking AUBAGIO or change your dose without talking to your doctor first.
Slovenian: Če ste prenehali jemati zdravilo AUBAGIO Ne prekinite zdravljenja z zdravilom AUBAGIO brez posvetovanja s svojim zdravnikom.
English: Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Slovenian: Enoodmerni perforirani pretisni omoti poliamid/aluminij/polivinilklorid v škatlah po 10 x 1 filmsko obloženih tablet.
English: • Complete blood cell count including differential white blood cell and platelet count.
Slovenian: • celotno krvno sliko z diferencialno sliko levkocitov in številom trombocitov.
English: If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used.
Slovenian: Če bolnik tega odmerka ne prenaša dobro, se lahko uporabi odmerek holestiramina 4 g trikrat na dan, 11 dni.
English: - if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious 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 have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Slovenian: (AIDS), - če imate resne težave s kostnim mozgom ali če imate v krvi nizko število rdečih ali belih krvničk ali znižano število krvnih ploščic, - če imate resno okužbo, - če imate hude težave z ledvicami, ki zahtevajo dializo, - če imate zelo znižane ravni beljakovin v krvi (hipoproteinemija), Če ste negotovi, se pred začetkom jemanja tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
English: - The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
Slovenian: - Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), hidroksipropilceluloza, magnezijev stearat, hipromeloza, titanov dioksid
English: The majority of patients had relapsing-remitting multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive relapsing multiple sclerosis (1.7%).
Slovenian: Podskupina bolnikov je imela sekundarno progresivno (0,8 %) ali progresivno recidivno multiplo sklerozo (1,7 %).
English: In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), was reported more frequently in patients taking teriflunomide than in patients taking placebo.
Slovenian: V s placebom kontroliranih študijah so pri bolnikih, ki so prejemali teriflunomid, pogosteje kot pri bolnikih, ki so prejemali placebo, poročali o periferni nevropatiji, vključno s polinevropatijo in mononevropatijo (npr. sindromom karpalnega kanala).
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje dislipidemija
English: Teriflunomide is contraindicated in pregnancy (see section 4.3).
Slovenian: Teriflunomid je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: Sanofi Belgium Tel/Tél/Tel: +32 (0)2 710 54 00
Slovenian: Tel/Tél/Tel : +32 (0)2 710 54 00
English: The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%).
Slovenian: Podskupina bolnikov je imela sekundarno progresivno (4,7 %) ali progresivno recidivno multiplo sklerozo (3,9 %).
English: The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Slovenian: Bolnico je treba poučiti, da v primeru zakasnitve pri pojavu menstruacije ali drugega razloga, ob katerem posumi na nosečnost, nemudoma obvesti zdravnika zaradi preiskave za nosečnost.
English: Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Teriflunomid je kontraindiciran pri bolnikih s hudo okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: Check with your doctor if you are not sure.
Slovenian: To bo preveril vaš zdravnik.
English: • Educational card for patients
Slovenian: • Opozorilno kartico za bolnika.
English: Sanofi AB Tel: +46 (0) 8 634 5000
Slovenian: Tel: +46 (0) 8 634 5000
English: A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
Slovenian: V študiji TEMSO so pri podskupini bolnikov (n  127) z zelo aktivno boleznijo ugotovili, da zdravljenje vpliva na recidive (zagone) in čas do 3-mesečnega ohranjenega napredovanja nezmožnosti.
English: How to take AUBAGIO
Slovenian: Kako jemati zdravilo AUBAGIO
English: • Affects liver function
Slovenian: • vpliva na delovanje jeter,
English: A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see section 4.8).
Slovenian: Opazili so povprečno zmanjšanje števila levkocitov < 15 % od izhodiščne vrednosti (glejte poglavje 4.8).
English: The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
Slovenian: Mediana vrednost EDSS v izhodišču je bila 2,50; 298 bolnikov (25,5 %) je v izhodišču imelo vrednost EDSS > 3,5.Povprečno trajanje bolezni, od pojava prvih simptomov, je bilo 8,0 let.
English: Anemia, decreased platelet counts and effects on the immune system, including leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or lymphoid organs.
Slovenian: limfopenijo in sekundarnimi okužbami, so bili povezani z učinki na kostni mozeg in/ali limfne organe.
English: Effect of teriflunomide on oral contraceptives: 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 teriflunomide.
Slovenian: Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,58-krat) in AUC0-24 (1,54-krat) za etinilestradiol in Cmax (1,33-krat) in AUC0-24 (1,41-krat) za levonorgestrel.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijsk a pljučna bolezen
English: There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Slovenian: Če so teriflunomid dali podganam moškega spola pred parjenjem z nezdravljenimi podganami ženskega spola, moški potomci niso imeli zunanjih malformacij.
English: AUBAGIO 14 mg film-coated tablets teriflunomide
Slovenian: AUBAGIO 14 mg filmsko obložene tablete teriflunomid
English: Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Slovenian: V obdobju po prihodu zdravila na trg so pri uporabi teriflunomida poročali o hudih kožnih reakcijah (glejte poglavje 4.4).
English: Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Slovenian: Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,7-krat) in AUC (2,4-krat) repaglinida, kar nakazuje, da je teriflunomid zaviralec CYP2C8 in vivo.
English: Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Slovenian: Infekcijske in parazitske bolezni gripa, okužba zgornjih dihal, okužba sečil, bronhitis, sinusitis, faringitis, cistitis, virusni gastroenteritis oralni herpes, zobna okužba, laringitis, tinea pedis hude okužbe, vključno s sepsoa
English: Mild allergic reactions
Slovenian: Bolezni imunskega sistema blage alergijske reakcije
English: ALT >3 ULN and TBILI >2 ULN
Slovenian: ALT > 3 ULN in TBILI > 2 ULN 5/994 (0,5%)
English: Use in males
Slovenian: Uporaba pri moških
English: What AUBAGIO is and what it is used for What AUBAGIO is
Slovenian: Kaj je zdravilo AUBAGIO in za kaj ga uporabljamo
English: Pollakiuria
Slovenian: ZLOŽENKA
English: Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali teriflunomid , so ugotovili zvišanje ravni jetrnih encimov (glejte poglavje 4.8.).
English: Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people) Headache
Slovenian: Pogosti (pojavijo se lahko pri do 1 od 10 uporabnikov)
English: - Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
Slovenian: pekoč občutek, mravljinčenje ali bolečine v dlaneh in prstih (sindrom karpalnega kanala), - občutek razbijanja srca, - povišan krvni tlak, - bruhanje, zobobol, bolečina v zgornjem delu trebuha, - izpuščaj, akne, - bolečine v kitah, sklepih, kosteh, mišicah (mišično-skeletna bolečina), - pogostejše uriniranje kot običajno, - močnejše menstrualne krvavitve, - bolečine, - pomanjkanje energije ali občutek šibkosti (astenija), - izguba telesne mase.
English: - you are switching to or from AUBAGIO.
Slovenian: - če začenjate ali končujete jemanje zdravila AUBAGIO.
English: • Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this.
Slovenian: • Kontracepcijo lahko prekinete šele, ko so ravni zdravila AUBAGIO v vaši krvi dovolj nizke.
English: For rosuvastatin, a dose reduction by 50% is recommended for coadministration with teriflunomide.
Slovenian: Pri sočasnem jemanju teriflunomida in rosuvastatina je priporočljivo zmanjšanje odmerka rosuvastatina za 50 %.
English: Effect of teriflunomide 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 teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Slovenian: Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,43-krat) in AUC (1,54-krat) cefaklora, kar nakazuje, da je teriflunomid zaviralec OAT3 in vivo.
English: cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Slovenian: Na osnovi izkušenj v kliničnih preskušanjih ne izgleda, da teriflunomid poveča tveganja za maligne bolezni.
English: A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Slovenian: Skupaj so randomizirali 618 bolnikov in sicer 205 na prejemanje 7 mg teriflunomida, 216 na prejemanje 14 mg teriflunomida in 197 na prejemanje placeba.
English: - severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
Slovenian: temnejši urin kot je normalno, nepojasnjeno slabost v želodcu in bruhanje ali bolečine v trebuhu, - vnetje pljuč, ki lahko vključuje simptome, kot so kratka sapa ali trdovraten kašelj, - vnetje trebušne slinavke, ki lahko vključuje simptome, kot so hude bolečine v zgornjem predelu trebuha, ki se lahko širijo v hrbet, slabost v želodcu ali bruhanje.
English: What AUBAGIO is used for
Slovenian: Za kaj zdravilo AUBAGIO uporabljamo
English: Hazard ratio (CI95%)
Slovenian: Klinični izidi letna stopnja recidivov razlika tveganja (95-odstotni IZ)
English: Teriflunomide 14 mg
Slovenian: teriflunomid 14 mg placebo teriflunomid 14 mg placebo
English: AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes).
Slovenian: Z omejevanjem povečevanja nekaterih belih krvnih celic (limfocitov) zdravilo AUBAGIO pomaga ščititi pred napadi imunskega sistema na centralni živčni sistem.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports (PSURs)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: • Blood pressure
Slovenian: • krvni tlak,
English: Common (may affect up to 1 in 10 people) - Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot - Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed.
Slovenian: - gripa, okužba zgornjih dihal, okužba sečil, bronhitis, sinusitis, boleče žrelo in nelagoden občutek pri požiranju, cistitis, virusni gastroenteritis, herpes v ustih, zobna okužba, laringitis, glivična okužba stopala, - laboratorijske vrednosti: zmanjšanje števila rdečih krvničk (anemija), opazili so spremembe preiskav za jetra in bele krvničke (glej poglavje 2), kot tudi zvišanje encima v mišicah (kreatin fosfokinaza), - blage alergijske reakcije, - občutek tesnobe, - mravljinčenje, šibkost, otrplost, mravljinčenje ali bolečine v ledvenem predelu ali nogi (išias); otrplost,
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
Slovenian: PODATKI NA VMESNI OVOJNINI
English: Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Slovenian: Zato se je treba pri bolnikih, ki prejemajo leflunomid ali teriflunomid, v primeru izmerjene znižane koncentracije ioniziranega kalcija vprašati o verodostojnosti dobljenega izvida.
English: sanofi-aventis groupe
Slovenian: Imetnik dovoljenja za promet z zdravilom: sanofi-aventis groupe