FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, caution should be used during handling and preparation of bortezomib.
Slovenian: Opozorilo: Bortezomib je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction,
Slovenian: Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
English: Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Slovenian: Bortezomib je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indiciran za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih.
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Slovenian: Pojavnost periferne nevropatije pri kombiniranem zdravljenju v študiji LYM-3002 z bortezomibom, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BR-CAP), je navedena v spodnji preglednici:
English: In cycles 1-4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: V ciklih 1-4 se bortezomib daje dvakrat na teden, na 1., 4., 8., 11., 22., 25., 29. in 32. dan, v ciklih 5-9 pa enkrat na teden, na 1., 8., 22. in 29. dan.
English: Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Slovenian: Bortezomib je indiciran za zdravljenje napredujočega diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali z deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev pri njih ni mogoča.
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following singleor repeated-dose intravenous administration of 1.0 mg/m or 1.3 mg/m to patients with multiple myeloma.
Slovenian: Porazdelitev Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
English: Bortezomib powder has to be dissolved before administration.
Slovenian: Bortezomib je v obliki praška, ki ga je potrebno raztopiti pred injiciranjem.
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib treatment cycle.
Slovenian: Deksametazon boste jemali peroralno v odmerku 40 mg na 1., 2., 3., 4., 8., 9., 10. in 11. dan 28- dnevnega cikla zdravljenja z bortezomibom.
English: Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors e
Slovenian: Razmerje tveganja manjše kot 1 kaže prednost zdravljenja z VMP. c Nominalna p-vrednost na osnovi stratificiranega log-rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: β2-micikllobulin, albumin in regija.
English: Progression-free survival Events n (%)
Slovenian: Preživetje brez napredovanja bolezni dogodki n (%) mediana a
English: 43.1 mo
Slovenian: < 0,001a
English: • In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and
Slovenian: - V ciklih 1 do 4 se bortezomib daje dvakrat na teden,1., 4., 8., 11., 22., 25., 29. in 32. dan. - V ciklih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
English: CR+nCR+PR % (95% CI)
Slovenian: *RR (po presaditvi) CR+nCR CR+nCR+PR % (95% CI)
English: BR-CAP group compared with 18 months in the R-CHOP group.
Slovenian: Mediana trajanja popolnega odgovora je bila 42,1 meseca v skupini BR-CAP in 18 mesecev v skupini R-CHOP.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Slovenian: Zdravilo Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
English: (95% CI)=0.63
Slovenian: (95 % CI) = 0,63 p-vrednost d mediana c(95 % CI) (meseci)
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Slovenian: Zdravilo Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje je za intravensko ali subkutano uporabo.
English: In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Slovenian: Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je študija faze III zdravljenja z bortezomibom vodila do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Slovenian: Psihiatrične motnje Pogosti motnje spanja* Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija *, nevralgija* Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična in motorična nevropatija, omotica*, disgevzija*, avtonomna nevropatija
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Slovenian: (9 mg/m2) in prednizonom (60 mg/m2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression-TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m2) in prednizonom
English: • need to handling the medicinal product in sterile setting
Slovenian: • Med ravnanjem z zdravilom je treba ves čas strogo upoštevati aseptično pripravo.
English: Neuropathic pain and/or peripheral neuropathy
Slovenian: periferna motorična nevropatija in periferna senzomotorična nevropatija.
English: Muscle spasms*, Pain in extremity, Muscular weakness
Slovenian: Zelo pogosti mišično-skeletna bolečina* Pogosti mišični krči*, bolečine v udih, mišična šibkost
English: Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Slovenian: e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
English: Reduce bortezomib to 1.0 mg/m or
Slovenian: Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m in 1,3 mg/m
English: Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention
Slovenian: Zelo pogosti zmanjšan apetit Pogosti hipokalemija*, nenormalne koncentracije glukoze v krvi *, hiponatriemija *, sladkorna bolezen*, zastajanje tekočine
English: Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Slovenian: Najpogostejši neželeni učinki (vseh stopenj), ki so se pojavili pri najmanj 25 % bolnikov so bili trombocitopenija (55 %), nevropatija (40 %), anemija (37 %), diareja (35 %) in zaprtje (28 %).
English: T 200 mg a
Slovenian: T 200 mg a na dan na dan na dan na dan
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids
Slovenian: • okužba veznice očesa in vek (konjuktivitis)
English: a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c
Slovenian: a p-vrednost podpira hipotezo, da SC krak zadrži najmanj 60 % stopnje odziva IV kraka zdravljenja.
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Slovenian: V 3. tednu 1. cikla se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. ciklu, če bolnik dobro prenaša odmerek 100 mg.
English: Very common Hair disorder* Common
Slovenian: Pogosti okvara ledvic*
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Slovenian: Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enokračno, študijo faze II MMY-2036 (RETRIEVE) pri stotrideset bolnikih (starih ≥ 18 let) z diseminiranim plazmocitomom.
English: Table 7 has been generated using Version 14.1 of the MedDRA. Post-marketing adverse reactions not seen in clinical trials are also included.
Slovenian: Preglednica 7 je pripravljena po klasifikaciji MedDRA, različica 14.1.
English: Table 4: Posology for bortezomib combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Slovenian: Preglednica 4: Odmerjanje kombiniranega zdravljenja z bortezomibom pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
English: -- -- -- -- rest period
Slovenian: -- -- -- -- pre mor
English: Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
Slovenian: B+M+P kraku študije je protivirusna zdravila prejelo 26 % bolnikov.
English: Patients in the BR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days
Slovenian: Bolniki v skupini BR-CAP so prejeli bortezomib (1,3 mg/m na
English: Psychiatric disorders
Slovenian: Bolezni jeter
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v 28 dnevnem ciklu zdravljenja.
English: Bortezomib may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Slovenian: Uporaba tega zdravila je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno) in ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto), zato morajo biti bolniki pri vožnji ali upravljanju strojev previdni.
English: • volume of reconstituted bortezomib (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Slovenian: in s.c. uporabo) glede na različne telesne površine (v povezavi z navodili za odmerjanje).
English: Gastrointestinal disorders Very common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Slovenian: Zelo pogosti bolezni las* Pogosti srbenje*, dermatitis*, izpuščaj*
English: Grade of hepatic impairment*
Slovenian: Pogosti okužba sečil *
English: Consider dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m in subsequent cycles based on patient tolerability.
Slovenian: Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja a odmerka na 1,0 mg/m ali zmanjšanja odmerka na 0,5 mg/m
English: Renal impairment*
Slovenian: Pogosti vrtoglavica*
English: visual loss or disturbances and shortness of breath
Slovenian: omedlevica - težave s kašljem in dihanjem ali tiščanje v prsih
English: Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Slovenian: Priporočamo, da bolniki, ki dosežejo odgovor šele v 6. ciklu, prejmejo dva dodatna cikla zdravljenja.
English: Nervous system disorders Very common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Slovenian: Redki samomorilne misli*, motnje prilagajanja, delirij, zmanjšan libido Bolezni živčevja Zelo pogosti nevropatije*, periferna senzorična nevropatija, disestezija*, nevralgija*
English: Reduce bortezomib to 0.7 mg/m in the first treatment cycle.
Slovenian: Pri bolnikih z zmerno ali hudo jetrno okvaro je treba zdravljenje uvesti z manjšim odmerkom bortezomiba 0,7 mg/m na injekcijo v prvem ciklu zdravljenja.
English: * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Slovenian: * VN.U: vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
English: Packaging Content Package Size
Slovenian: Pakiranje Vsebina Velikost pakiranja
English: Target Species Route of administration
Slovenian: Ciljna živalska vrsta
English: Withdrawal period
Slovenian: Način uporabe
English: EU/2/99/017/001 Bovalto Ibraxion gE deleted inactivated IBR virus, at least 0.75
Slovenian: 5 odmerkov 10 ml steklenička
English: - If you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Slovenian: - če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s kom, ki je imel ali ima tuberkulozo.
English: Postmarketing Studies
Slovenian: Postmarketinške študije
English: Folate supplementation was optional and only used in 10 % of patients.
Slovenian: Dodajanje folata je bilo fakultativno in uporabljeno le pri 10 % bolnikov.
English: Excretion data from the 14C study indicated that at least about 82 to 95 % of the dose is absorbed.
Slovenian: Podatki o ekskreciji iz študije 14C so pokazali, da se absorbira vsaj 82 do 95 % odmerka.
English: If this happens to you, do not drive or use machines.
Slovenian: Čese vam to zgodi, ne vozite oziroma ne upravljajte s stroji.
English: Repso tablets can be taken with or without food.
Slovenian: Tablete zdravila Repso lahko vzamete z ali brez hrane.
English: Children and adolescents Repso is not recommended for use in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Uporaba zdravila Repso ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Pharmacokinetic data in elderly people (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Slovenian: Farmakokinetični podatki pri starejših (> 65 let) so omejeni, vendar skladni s farmakokinetiko pri mlajših odraslih.
English: NSAIDs/Corticosteroids
Slovenian: NSAIDs/kortikosteroidi
English: For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Slovenian: Za postopke izpiranja in druge priporočene ukrepe v primeru načrtovane ali nenačrtovane nosečnosti glejte poglavje 4.6.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: - If you are woman of child-bearing age and not using effective contraception.
Slovenian: - če ste ženska v rodni dobi in ne uporabljate učinkovite kontracepcije.
English: - If you have ever had interstitial lung disease (feeling a shortness of breath).
Slovenian: - če ste kdaj imeli intersticijsko bolezen pljuč (občutek kratke sape).
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Repso from your body.
Slovenian: To obdobje je mogoče skrajšati na nekaj tednov z jemanjem določenih zdravil, ki pospešijo odstranjevanje zdravila Repso iz telesa.
English: What Repso is and what it is used for
Slovenian: Kaj je zdravilo Repso in za kaj ga uporabljamo
English: Repso is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Slovenian: Zdravila Repso ni priporočljivo uporabljati za bolnike do 18. leta starosti, ker učinkovitost in varnost pri juvenilnem revmatoidnem artritisu (JRA) nista ugotovljeni (glejte poglavji 5.1 in 5.2).
English: Lactose monohydrate Povidone
Slovenian: Laktoza monohidrat Povidon
English: hypokalaemia, hyperlipidemia, hypophosphataemia
Slovenian: hipokaliemija, hiperlipidemija, hipofosfatemija
English: Repso belongs to a group of medicines called anti-rheumatic medicines.
Slovenian: Zdravilo Repso spada v skupino zdravil, ki jih imenujemo antirevmatična zdravila.
English: Repso tablets are tablets for oral use.
Slovenian: Tablete Repso so tablete za peroralno uporabo.
English: Most patients improved after discontinuation of Repso.
Slovenian: Večini bolnikov se je po prenehanju jemanja zdravila Repso stanje izboljšalo.
English: If you forget to take Repso
Slovenian: Če ste pozabili vzeti zdravilo Repso
English: Psoriatic arthritis is the combination of psoriasis and arthritis.
Slovenian: Psoriatični artritis je kombinacija psoriaze in artritisa.
English: In either case it should be confirmed by a blood test that Repso has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Slovenian: V obeh primerih je treba s krvno preiskavo potrditi, da se je zdravilo Repso dovolj odstranilo iz telesa, potem pa morate počakati vsaj še en mesec, preden zanosite.
English: The unbound fraction of A771726 is about 0.62 %.
Slovenian: Nevezana frakcija A771726 je približno 0,62 %.
English: What you need to know before you take Repso
Slovenian: Kaj morate vedeti, preden boste vzeli zadravilo Repso
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu/.
English: If you are pregnant or become pregnant while taking Repso, the risk of having a baby with serious birth defects is increased.
Slovenian: Če ste noseči ali zanosite med jemanjem zdravila Repso, je povečano tveganje, da se rodi otrok z resnimi prirojenimi okvarami.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glej Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The risk of their occurrence can be increased in patients with a history of interstitial lung disease.
Slovenian: Tveganje za njihov nastanek se lahko poveča pri bolnikih z intersticijsko boleznijo pljuč v anamnezi.
English: - If you have liver problems.
Slovenian: - če imate kakršnekoli težave z jetri.
English: Other medicines and Repso
Slovenian: Druga zdravila in zdravilo Repso
English: Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Slovenian: Zdravilo Repso se uporablja za zdravljenje odraslih bolnikov z aktivnim revmatoidnim artritisom ali aktivnim psoriatičnim artritisom.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.
Slovenian: Znižanje koncentracije pod 0,02 mg/l je mogoče pričakovati približno 2 leti po prenehanju zdravljenja z leflunomidom.
English: Effect on organic anion transporter 3 (OAT3) substrates
Slovenian: Vpliv na substrate prenašalca organskih anionov 3 (OAT3)
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Repso rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Slovenian: Če test potrdi, da ste noseči, vam bo zdravnik morda predlagal zdravljenje z določenimi zdravili, ki hitro in uspešno odstranijo zdravilo Repso iz vašega telesa, ker to lahko zmanjša tveganje za otroka.
English: Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Slovenian: Rezultati študij plodnosti pri živalih niso pokazali učinka na plodnost pri moških in ženskah, pač pa so v študijah toksičnosti ponavljajočih se odmerkov opazili neželene učinke na moške reproduktivne organe (glejte poglavje 5.3).
English: Repso can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Slovenian: Občasno lahko zdravilo Repso povzroči nekatere krvne, jetrne, pljučne težave ali težave z živci v rokah in nogah.
English: - Mild allergic reactions.
Slovenian: blage alergijske reakcije
English: paraesthesia, headache, dizziness, peripheral neuropathy
Slovenian: parestezije, glavobol, omotica, periferna nevropatija
English: For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/l):
Slovenian: Pri ženskah, ki prejemajo leflunomid in želijo zanositi, je treba z enim od naslednjih postopkov zagotoviti, da plod ne bo izpostavljen toksični koncentraciji A771726 (ciljna koncentracija je pod 0,02 mg/l):
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid
Slovenian: mejno (reverzibilno) znižanje koncentracije semenčic, celotnega števila semenčic in
English: Rare: Not known:
Slovenian: Redki: Neznani:
English: - If you switch to another medicine to treat your rheumatoid arthritis or if you have recently taken medicines that may be harmful to your liver or blood, your doctor may advise you to take certain medicines to speed up the removal of Repso from your body or may closely monitor you when you start taking Repso.
Slovenian: - če ste prej jemali druga zdravila za zdravljenje revmatoidnega artritisa ali če ste pred kratkim jemali zdravila, ki lahko škodujejo vašim jetrom ali krvi, vam bo zdravnik morda predlagal, da vzamete zdravila, ki bodo pospešila izločanje zdravilo Repso iz vašega telesa ali vas bo natančno spremljal ob začetku jemanja zdravila Repso.
English: In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Slovenian: V študiji z radioaktivno označenim 14C-leflunomidom pri 3 zdravih prostovoljcih v plazmi, urinu ali blatu niso našli nespremenjenega leflunomida.
English: - The other ingredients are (see section 2 “Repso contains lactose”)
Slovenian: - Pomožne snovi so (glejte poglavje 2 "Zdravilo Repso vsebuje laktozo")