FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP was also concerned by the potential longterm consequences of liver test results showing a build-up of fat in the liver and increased enzyme levels, and was not convinced that the company had proposed sufficient measures to prevent the risk of irreversible liver damage.
Maltese: Is-CHMP kien ukoll imħasseb dwar il-konsegwenzi potenzjali fit-tul ta' riżultati tat-testijiet tal-fwied li juru akkumulazzjoni ta' xaħam fil-fwied u żieda fl-enzimi talfwied, u ma kienx konvint li l-kumpanija kienet ipproponiet miżuri suffiċjenti biex tipprevjeni r-riskju ta' ħsara irriversibbli fil-fwied.
English: Invented
Maltese: Ippakkjar
English: EU Number
Maltese: Numru tal-UE Isem
English: Route of administration
Maltese: Mod t'amministraz zjoni
English: Strength Pharmaceutical
Maltese: Żmien ta' Tiżmim
English: NSAIDS/Corticosteroids
Maltese: NSAIDS/Kortikosterojdi
English: Tablet 30 tablets 100 tablets
Maltese: Pillola 30 pillola 100 pillola
English: Teva Denmark A/S Tlf: +45 44 98 55 11
Maltese: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
English: Teva UK Limited Tel: +44 (0)1977 628500
Maltese: United Kingdom Teva UK Limited Tel: +44 (0)1977 628500
English: Film-coating Lecithin (soybeans) Poly(vinyl alcohol) Talc
Maltese: Ir-rita tal-pillola Lecithin (soybeans) Poly(vinyl alcohol) Talc
English: Warfarin and other coumarine anticoagulants
Maltese: Warfarin u antikoagulanti coumarine oħrajn
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide ratiopharm.
Maltese: Dan il-prodott metaboliku huwa essenzjalment responsabbli għall-attivita kollha in vivo ta' Leflunomide ratiopharm.
English: 3 days.
Maltese: 11-il jum.
English: EU/1/10/654/001 EU/1/10/654/002
Maltese: EU/1/10/654/002
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia
Maltese: panċitopenja (probabilment minn mekkaniżmu anti-proliferattiv), lewkopenja (lewkoċiti <2 G/L), esinofilja
English: Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 76 mg ta' lactose u 0.06 mg ta' soya lecithin.
English: EU/1/10/654/003 EU/1/10/654/004
Maltese: EU/1/10/654/004
English: Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster
Maltese: Haupt Pharma Münster GmbH Schleebrüggenkamp 15
English: severe infections, including sepsis which may be fatal
Maltese: infezzjonijiet severi, inkluż sepsis li tista' tkun fatali
English: anaemia, mild thrombocytopenia (platelets <100 G/L)
Maltese: anemija, tromboċitopenja ħafifa (plejtlets <100 G/L)
English: NAME OF THE MEDICINAL PRODUCT
Maltese: (reference medicinal product).
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs. 28.6% (study MN301), and 49.4% vs. 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 MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients.
Maltese: Wara 12-il xahar ta' kura attiva, ir-rati ta' rispons skond l-ACR fil-pazjenti fuq leflunomide kienu 52.3% (studji MN301/303), 50.5% (studju MN302) u 49.4% (studju US301), ikkomparati ma' 53.8% (studji MN301/303) tal-pazjenti fuq sulphasalzine, 64.8% (studju MN302), u 43.9% (studju US301) tal-pazjenti fuq methotrexate.
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Il-Ġermanja
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 19 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Novembru 2010
English: - The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating
Maltese: • Is-sustanżi l-oħra huma lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate u magnesium stearate fil-qalba tal-pillola kif ukoll lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) u xanthan gum fir-rita tal-pillola.
English: • Patients with serious infections (see section 4.4),
Maltese: • Pazjenti b'infezzjonijiet severi, (ara sezzjoni 4.4),
English: EU/1/10/654/003 30 film-coated tablets EU/1/10/654/004 100 film-coated tablets
Maltese: EU/1/10/654/003 30 pilloli miksija b'rita EU/1/10/654/004 100 pilloli miksija b'rita
English: EU/1/10/654/001 30 film-coated tablets EU/1/10/654/002 100 film-coated tablets
Maltese: EU/1/10/654/001 30 pilloli miksija b'rita EU/1/10/654/002 100 pilloli miksija b'rita
English: Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59% in the leflunomide group and 29.7% in the placebo group by 6 months (p<0.0001).
Maltese: Leflunomide f'doża ta' 20 mg/jum kien superjuri b'mod sinifikanti meta mqabbel mal-plaċebo fittnaqqis tas-sintomi ta' l-artrite f'pazjenti bl-artrite psorjatika: il-pazjenti li kienu jissodisfaw il-PsARC (Psoriatic Arthritis treatment Response Criteria) kienu 59% għall-grupp ta' leflunomide u 29.7% għall-grupp tal-plaċebo, fi żmien 6 xhur (p <0.
English: Leflunomide ratiopharm contains soya lecithin
Maltese: Leflunomide ratiopharm fih soya lecithin.
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10% to 50%.
Maltese: A771726 jisposta lil ibuprofen, lil diclofenac u lil tolbutamide, iżda l-parti mhux marbuta ta' dawn il-mediċini tiżdied biss b'10% sa 50%.
English: • For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.
Maltese: • Għall-artrite psorjatika: 20 mg Leflunomide ratiopharm darba kuljum.
English: Effect on oral contraceptive (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 A771726.
Maltese: Kien hemm żieda fil-medja tas-Cmax u l-AUC0-24 (1.58 u 1.54 darbiet, rispettivament) ta' ethinylestradiol, u fis-Cmax u l-AUC0-24 (1.33 u 1.41 darbiet, rispettivament) ta' levonorgestrel, wara lgħoti ta' dożi ripetuti ta' A771726.
English: The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
Maltese: II, YU203, 402 pazjenti li kellhom l-artrite rewmatikaattiva kienu mqassmin, mingħajr għażla, f'erba' gruppi: dawk bil-plaċebo (n = 102) u dawk b'5 mg (n = 95), 10 mg (n = 101) jew 25 mg (n = 104) leflunomide kuljum.
English: The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Maltese: L-effikaċja ta' leflunomide intwera fi studju wieħed 3L01, li kien ikkontrollat, randomised u double blind u li sar fuq 188 pazjent bl-artrite psorjatika, ittrattati b'20 mg/jum.
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain; colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Maltese: dijarrea, tqalligħ, rimettar, disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali; kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenika
English: - The active substance is leflunomide.
Maltese: • Is-sustanza attiva hija leflunomide.
English: Tablet core
Maltese: ipertensjoni pulmonari
English: Risk Management Plan (RMP)
Maltese: Pjan tal-immaniġġar tar-Riskju (RMP)
English: Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines.
Maltese: Leflunomide ratiopharm fih is-sustanza attiva leflunomide, li tappartjeni għall-grupp ta' mediċini msejħa antirewmatiċi.
English: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Mhux magħruf lupus eritematożu kutanju, psorijażi pustulari jew il-psorijażi tmur għallagħar, Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS)
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Maltese: Biex jitnaqqas kull riskju possibbli, l-irġiel li jixtiequ jsiru missirijiet għandhom iqisu jekk għandhomx iwaqqfu l-użu ta' leflunomide, u jieħdu 8 g colestyramine 3 darbiet kuljum għal 11-il jum, jew 50 g ta' trab ta` faħam mediċinali attivat 4 darbiet kuljum għal 11-il jum.
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37% in 24 hours and by 48% in 48 hours.
Maltese: Intwera li t-teħid ta' faħam attivat (trab f'suspensjoni) mill-ħalq jew permezz ta' tubu li jgħaddi mill-imnieħer u jidħol fl-istonku (50 g kull 6 sigħat għal 24 siegħa), jnaqqas il-livelli fil-plażma talprodott metaboliku attiv, A771726, b' 37% f'24 siegħa u b'48% f'48 siegħa.
English: Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy.
Maltese: Età ta' aktar minn 60 sena, mediċini newrotossiċi li jingħataw fl-istess waqt, u ddijabete jistgħu jżidu r-riskju tan-newropatija periferika.
English: • Patients with severe immunodeficiency states, e.g. AIDS,
Maltese: • Pazjenti li għandhom stat ta' nuqqas immunoloġiku e.g. l-AIDS,
English: severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Maltese: • reazzjonijiet severi, x'imdaqqiet fatali (is-sindrome ta' Stevens-Johnson, in-nekrosi tossika u esfoljattiva tal-ġilda, eritema multiforme).
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Maltese: Il-komportament farnakokinetiku ta' A771726 wara t-teħid orali ta' leflunomide kien studjat f'73 pazjent pedjatriku li kellhom l-Artrite Rewmatika taż-Zgħażagħ (JRA), li effettwat diversi ġogi, u li kellhom minn 3 sa 17-il sena fl-età.
English: Leflunomide ratiopharm contains lactose.
Maltese: Leflunomide ratiopharm fih il lactose.
English: Metabolism and nutrition disorders Common:
Maltese: Disturbi fil- metaboliżmu u n-nutrizzjoni
English: Leflunomide ratiopharm 10 mg tablets Leflunomide
Maltese: Leflunomide ratiopharm 10 mg pilloli Leflunomide
English: UAB "Sicor Biotech" Tel: +370 5 266 0203
Maltese: UAB "Sicor Biotech" filiāle Latvijā Tel: +371 673 236 66
English: Leflunomide ratiopharm 20 mg tablets Leflunomide
Maltese: Leflunomide ratiopharm 20 mg pilloli Leflunomide
English: Leflunomide
Maltese: Il-Manifattur
English: Contains lactose and soya lecithin.
Maltese: Fih lactose u soya lecithin.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, to peanut or soya or to any of the excipients listed in section 6.1,
Maltese: • Sensitività eċċessiva (speċjalment jekk kellhom preċedentement is-sindromu Stevens-Johnson, in-nekrożi tossika u esfoljattiva tal-ġilda, l-eritema multiforme) għas-sustanza attiva, għallprodott metaboliku attiv prinċipali teriflunomide, għall-karawett jew sojja jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1,
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, to peanut or soya or to any of the excipients listed in section 6.1.
Maltese: • Sensitività eċċessiva (speċjalment jekk kellhom preċedentement is-sindromu Stevens-Johnson, in-nekrożi tossika u esfoljattiva tal-ġilda, l-eritema multiforme) għas-sustanza attiva, għallprodott metaboliku attiv prinċipali teriflunomide, għall-karawett jew sojja jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: 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).
Maltese: Ir-reazzjonijiet avversi l-aktar irrapportati bi leflunomide huma: żieda ħafifa fil-pressjoni tad-demm, lewkopenja, parasteżija, uġigħ ta' ras, sturdament, dijarrea, tqalligħ, rimettar, disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali, twaqqigħ tax-xagħar aktar minn normal, ekżema, raxx (jinkludi raxx ikkaratteriżżat minn titbigħ u ponot), ħakk, ġilda xotta, tenosynovitis, żieda fi CPK, anoreksja, telf fil-piż (normalment mhux sinifikanti), astenja, reazzjonijiet allerġiċi ħfief u livelli għoljin tal-parametri tal-fwied (l-enżimi transaminases [speċjalment ALT], anqas spiss gamma-GT, alkaline phosphatase, bilirubin).
English: • For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the severity of the disease.
Maltese: • Għall-artrite rewmatika: 10 mg jew 20 mg ta' Leflunomide ratiopharm darba kuljum , skond is-severità tal-marda.
English: Teva Eesti esindus UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
Maltese: Eesti filiaal Tel: +372 661 0801
English: The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Maltese: Il-kejl tal-livelli ta' kalċju jonizzat jista' juri tnaqqis falz fil-valuri taħt il-kura b'leflunomid u/jew teriflunomid (il-metabolit attiv ta' leflunomide) skont it-tip ta' analizzatur ta' kalċju jonizzat użat (pereżempju analizzatur bil-gas tad-demm).
English: Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Maltese: Leflunomide ratiopharm huwa wżat biex jittratta pazjenti adulti b'artrite rewmatojde attiva jew b'artrite psorjatika attiva.
English: Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 152 mg ta' lactose u 0.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Maltese: • Pazjenti li għandhom stat ta' nuqqas immunoloġiku e.g. l-AIDS.
English: How to store Leflunomide ratiopharm Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: How to take Leflunomide ratiopharm
Maltese: X'fih Leflunomide ratiopharm
English: It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).
Maltese: Intwera li fil-bniedem it-teħid ta' suspenzjoni orali tat-trab ta' faħam mediċinali attivat jew ta' colestyramine iwassal għal żieda mgħaġġla u sinifikanti fir-rata t'eliminazzjoni ta' A771726 u tnaqqis fil-livelli fil-plażma (ara sezzjoni 4.9).
English: 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).
Maltese: Wara 16-il ġimgha trattament, id-differenzi fir-rati tar-rispons kienu statistikament sinifikanti favur methotrexate għall-JRA Definition of Improvement (DOI) >30% (p = 0.02).
English: hypokalaemia, hyperlipidemia, hypophosphataemia
Maltese: livell baxx ta' potassju fid-demm, iperlipidemja, ipofosfatimja
English: 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) - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
Maltese: monitoraġġ sabiex jitnaqqas ir-riskju ta' effetti sekondarji minn din il-mediċina - teriflunomide għas-sklerożi multipla - repaglinide, pioglitazone, nateglinide, jew rosiglitazone għad-dijabete - daunorubicin, doxorubicin, paclitaxel, jew topotecan għal kanċer - duloxetine għad-depressjoni, inkontinenza awrinarja jew għall-mard tal-kliewi fid-dijabetiċi - alosetron għall-immaniġġar ta' dijarea severa - theophylline għall-ażma - tizanidine, rilassant tal-muskoli - kontraċettivi orali (li fihom ethinylestradiol u levonorgestrel)
English: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately
Maltese: F'doża ta' 20 mg kuljum, il-livell medju fil-plażma ta' A771726 fi stat stabbli kien ta' madwar 35 μg/mL.
English: Alternatively, 50 g of activated powdered charcoal is administered 4 times daily.
Maltese: Minnflok, jista' jingħata 50 g ta' faħam mediċinali attivat 4 darbiet kuljum.
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Maltese: Ir-riżultati ta' l-analiżi farmakokinetika ta' dan il-grupp ta' suġġetti, f'dawn il-provi, urew li l-pazjenti pedjatriċi li kellhom piż ta ≤40 kg, kellhom espożizzjoni sistemika mnaqqsa (mkejjla permezz ta' Css) ta' A771726, meta mqabblin ma' pazjenti adulti bl-artrite rewmatika (ara sezzjoni 4.2).
English: Each tablet contains 10 mg of leflunomide.
Maltese: Kull pillola fiha 10 mg ta' leflunomide.
English: hypouricemia
Maltese: FARMAĊEWTIKU
English: anxiety
Maltese: anzjetà
English: This medicinal product contains lactose and soya lecithin.
Maltese: TA' EĊĊIPJENTI Dan il-prodott mediċinali fih il-lactose u soya lecithin.
English: Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years of age.
Maltese: Leflunomide ratiopharm malajr u biżżejjed minn ġismek, għax dan jista' jnaqqas ir-riskju għat-tarbija tiegħek.
English: Leflunomide ratiopharm contains lactose
Maltese: Kif taħżen Leflunomide ratiopharm
English: 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) - zidovudine for HIV infection
Maltese: - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin għall-infezzjonijiet - indomethacin, ketoprofen għall-uġigħ jew għall-infjammazzjoni - furosemide għall-mard tal-qalb (dijuretiku, pillola tal-ilma) - zidovudine għall-infezzjoni bl-HIV - rosuvastatin, simvastatin, atorvastatin, pravastatin għall-iperkolesterolimja (kolesterol għoli) - sulfasalazine għall-mard infjammatorju tal-imsaren jew artrite rewmatojdeja - mediċina msejjaħ colestyramine (użat fil-kura ta' livelli għolja tax-xaħam fid-demm) u faħam mediċinali attivat billi dawn il-mediċini jistgħu naqqsu l-ammont ta' Leflunomide ratiopharm li huma assorbiti mill-ġisem.
English: How to store Leflunomide ratiopharm
Maltese: Tiħux Leflunomide ratiopharm
English: It has immunomodulating/
Maltese: Infezzjonijiet u infestazzjonijiet
English: • Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome,
Maltese: • problemi bin-nervituri tad-dirgħajn u r-riġlejn (newropatija periferali),
English: - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Maltese: Leflunomide huwa sustanza b'karatteristiċi anti-proliferattivi li taġixxi bħala prodott anti-rewmatoloġiku.
English: See sextion 4.
Maltese: 4% kontra 26.
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: If both plasma concentrations are below 0.02 mg/L, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Maltese: Jekk il-livelli fil-plażma jkunu inqas minn 0.02 mg/L, u wara stennija ta' mhux anqas minn 3 xhur, ir-riskju ta' tossiċità għall-fetu huwa żgħir ħafna.
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).
Maltese: Ir-riżultati ta‘ studji dwar il-fertilità fl-annimali ma wrew l-ebda effett fuq il-fertilità tal-irġiel u tannisa, iżda effetti avversi fuq l-organi riproduttivi tal-irġiel ġew osservati fi studji dwar tossiċità minn dożi ripetuti (ara sezzjoni 5.3).
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40%, whereas the AUC was not significantly changed.
Maltese: Wara t-teħid konkomittanti ta' doża waħda ta' leflunomide, f'pazjenti li kienu qed jieħdu dożi multipli ta` rifampicin (stimulatur mhux speċifiku taċ-ċitokromju P450), il-livelli l-aktar għoljin ta' A771726 żdiedu b'madwar 40%, fil-waqt li l-AUC ma nbidlitx b'mod sinifikanti.