qanastek/EMEA-V3 huggingface dataset:
The principal faecal component was A771726.
Il- komponent prinċipali fl- ippurgar kien A771726.
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).
Intwera li fil- bniedem it- teħid ta ’ suspenzjoni orali tat- trab ta ’ charcoal 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).
This is thought to be achieved by a gastrointestinal dialysis mechanism and/ or by interrupting enterohepatic recycling.
Huwa maħsub li dan jintlaħaq permezz ta ’ mekkaniżmu ta ’ dijaliżi gastro- intestinali u/ jew billi jkun interrott ir- reċiklaġġ enteroepatiku.
Pharmacokinetics in renal failure
Tagħrif farmakokinetiku fl- insuffiċjenza renali
Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD).
Leflunomide ngħata bħal doża waħda orali ta ’ 100 mg lil 3 pazjenti fuq id- dijaliżi tad- demm u lil 3 pazjenti oħra fuq id- dijaliżi kontinwa mill- peritonew (CAPD).
The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Il- komportament farmakokinetiku ta ’ A771726 fil - pazjenti ta ’ CAPD deher simili għal dik f’ voluntiera b’ saħħithom.
A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of drug in the dialysate.
Eliminazzjoni aktar mgħaġġla ta ’ A771726 intweriet f’ pazjenti fuq id- dijaliżi tad- demm, li ma kienx dovut għat- tneħħija tas- sustanza - fil- likwidu tad- dijaliżi.
13 Pharmacokinetics in liver failure
Tagħrif farmakokinetiku fl- insuffiċjenza tal- fwied
No data are available regarding treatment of patients with hepatic impairment.
M’ hemmx tagħrif rigward il- kura ta ’ pazjenti li għandhom indeboliment tal- fwied.
The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Il- prodott metaboliku attiv, A771726, huwa estensivament marbut mal- proteina u jitneħħa permezz tal - metaboliżmu tal- fwied u s- sekrezzjoni biljari.
These processes may be affected by hepatic dysfunction.
Dawn il- proċessi jistgħu jkunu effettwati minn disfunzjoni tal- fwied.
Pharmacokinetics in paediatrics
Komportament farmakokinetiku fis- suġġetti pedjatriċi
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.
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.
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 4.2).
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).
Pharmacokinetics in elderly
Komportament farmakokinetiku fl- anzjani
Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
It- tagħrif farmakokinetiku fl- anzjani (> 65 sena) huwa limitat, iżda hija konsistenti mal- komportament farmakokinetiku f’ pazjenti adulti ta ’ età iżgħar.
5.3 Preclinical safety data
14 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Leflunomide, li ngħata oralment u fil- kavita tal- peritonew, kien studjat mill- aspett ta ’ tossiċità akuta fil- ġrieden u l- firien.
Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
It- teħid orali u repetut ta ’ leflunomide fil- ġrieden għal perijodu sa 3 xhur, fil - firien u l- klieb għal perijodu sa 6 xhur, u fix- xadini għal- perijodu ta ’ xahar, svela li l- organi maġġuri milquta mit- tossiċità kienu l- mudullun, id- demm, il- passaġġ gastro- intestinali, il- ġilda, il- milsa, it- timu u l- glandoli limfatiċi.
The main effects were anaemia, leucopenia, decreased platelet counts and panmyelopathy and reflect the basic mode of action of the compound (inhibition of DNA synthesis).
Dawn jirriflettu l- mod bażiku ta ’ kif taħdem din is- sustanza (inibizzjoni tas- sinteżi tad- DNA).
In rats and dogs, Heinz bodies and/ or Howell-Jolly bodies were found.
Fil- firien u l- klieb, instabu l- korpi ta ’ Heinz u/ jew il- korpi ta ’ Howell- Jolly.
Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression.
Effetti oħra li seħħew fuq il- qalb, il- fwied, il- kornea u fis- sistema respiratorja setgħu kienu dovuti għall- infezzjonijiet minħabba t- trażżin ta ’ l- immunità.
Toxicity in animals was found at doses equivalent to human therapeutic doses.
It- tossiċità fl- annimali dehret f’ dożi ekwivalenti għal dawk terapewtiċi fil- bniedem.
Leflunomide was not mutagenic.
Leflunomide m’ huwiex mutaġeniku.
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Madankollu, l- prodott metaboliku minuri, TFMA (4- trifluoromethylaniline) ikkaġuna ksur u tħarbit tal- kromożomi, kif ukoll mutazzjonijiet dovuti għal bidla ta ’ par wieħed tan- nuklejtidi tad- DNA; fil- waqt li l- informazzjoni ma kienitx biżżejjed biex tixħet dawl fuq il- potenżjal biex ikun eżerċitat dan l- effett in vivo.
In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Fi studju karsinoġeniku fuq il- firien, leflunomide m’ uriex potenzjal li jikkaġuna l- kanċer.
In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide.
Fi studju karsinoġeniku fil- ġrieden, kienet osservata żieda fl- inċidenza tal- linfoma malinna f’ dawk ta ’ sess maskil, li kienu fil- grupp li rċevew l- ogħla doża.
In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Dan kien meqjus li kien minħabba l- attività immunosoppressiva ta ’ leflunomide.
The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain.
Fil- ġrieden ta ’ sess femminil, kien hemm żieda fl- inċidenza ta ’ adenomi u kanċer tal- pulmun tat- tip bronkjolo- alvejolari, li kienu iddeterminati mid- doża użata Ir - relevanza ta ’ dawn ir- reperti fil- ġrieden, relatati ma ’ l- użu kliniku ta ’ leflunomide, mhux magħruf b’ ċertezza.
Leflunomide was not antigenic in animal models.
Leflunomide ma kienx antiġeniku fi provi fuq l- annimali.
Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Eżerċita wkoll effetti fuq l- organi riproduttivi maskili b’ dożi repetuti, fi studji fuq it - tossiċità.
Fertility was not reduced.
Il- fertilità ma tnaqqsitx.
6.1 List of excipients
6. 1 Lista ta ’ sustanzji mhux attivi
Maize starch povidone (E1201) crospovidone (E1202) 14 silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Maize starch povidone (E1201) crospovidone (E1202) silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Film-coating:
Ir- rita tal- pillola:
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000
6.4 Special precautions for storage
15 6. 4 Prekawzjonijiet speċjali għal ħażna
Aluminium / Aluminium blister.
Aluminju/ fojl ta ’ l- aluminju.
30 and 100 film-coated tablets.
30 u 100 pilloli miksija b’ rita.
HDPE-wide-necked bottle, 100 ml with screw cap with integrated desiccant container.
Flixkun tal- HDPE b’ għonqu wiesa ’, 100 ml, b’ tapp tal- kamin, b’ dessikant integrat fil - kontenitur.
Pack sizes:
Daqsijiet:
30 and 100 film coated tablets.
30 u 100 pilloli miksija b’ rita.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Ġermanja
02 September 1999 Date of latest renewal:
02 ta ’ Settembru 1999 Data ta ’ l- aħħar tiġdid:
02 September 2004
02 ta ’ Settembru 2004
Arava 20 mg film-coated tablets
Arava 20 mg pilloli miksija b’ rita.
Each film-coated tablet contains 20 mg of leflunomide and 72 mg of lactose.
Kull pillola miksija b’ rita fiha 20 mg ta ’ leflunomide u 72 mg ta ’ lactose.
Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side.
Pillola miksija b’ rita, ta ’ kulur safrani sa kulur safrani ċar fil- kannella, għamla trijangulari, stampata b’ ZBO fuq faċċata waħda.
Leflunomide is indicated for the treatment of adult patients with: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), • active psoriatic arthritis.
Leflunomide huwa indikat għall- kura ta ’ pazjenti adulti li jbatu minn: • artrite attiva, tat- tip rewmatojde bħala “ mediċina antirewmatika li timmodifika l- marda ” (DMARD), • artrite psorjatika attiva
The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
L- effett terapewtiku normalment jibda minn 4 sa 6 ġimgħat wara li tinbeda l- kura u tista ’ tkompli titjieb minn 4 sa 6 xhur wara.
Alanine aminotransferase (ALT) (or serum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: • before initiation of leflunomide, • every two weeks during the first six months of treatment, and • every 8 weeks thereafter (see also section 4.4).
Alanine aminotransferase (ALT) (jew serum glutamopyruvate transferase SGPT) u test komplut tad - demm, fejn jingħaddu ċ- ċelluli kollha, inklużi t- tipi diversi kollha taċ- ċelluli bojod u l- plejtlits, iridu jsiru simultanjament u bl- istess frekwenza: • qabel ma jinbeda leflunomide, • kull ġimgħatejn fl- ewwel sitt xhur tal- kura, u • kull 8 ġimgħat minn hemm ’ il quddiem (ara wkoll sezzjoni 4. 4).
16 Posology
17 Pożoloġija
• hypersensitivity to the active substance (especially previous Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients,
sensitività eċċessiva għas- sustanza attiva (speċjalment jekk kellhom preċedentement is- sindromu Stevens- Johnson, in- nekrożi tossika u esfoljattiva tal- ġilda, l- eritema multiforme), jew għal xi wieħed mis- sustanzi mhux attivi
• patients with serious infections (see section 4.4),
• pazjenti b’ infezzjonijiet severi, (ara sezzjoni 4. 4),
• pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/ l (see also section 4.6).
• nisa tqal, jew dawk in- nisa li għadhom fl- età li jkollhom it- tfal u mhux qegħdin jużaw kontraċettivi effettivi waqt il- kura b’ leflunomide, u wara, sakemm il- livelli fil- plażma tal - prodott metaboliku attiv ikunu ’ l fuq minn 0. 02 mg/ l (ara wkoll sezzjoni 4. 6).
The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
18 Il- prodott metaboliku attiv ta ’ leflunomide, A771726, għandu half- life twila, ġeneralment 1 sa 4 ġimgħat.
Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
Għalhekk, meta jkun hemm dawn l- effetti tossiċi, jew jekk għal xi raġuni oħra A771726 għandu jiġi mneħħi malajr mill - ġisem, il- proċedura li tneħħi din ta ’ l- aħħar mill- ġisem trid tkun segwita.
17 For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Għal dan il- għan, u xi miżuri oħra irrakkomandati f’ każ ta ’ tqala mixtieqa jew mhux ippjanata, ara sezzjoni 4. 6.
The use of leflunomide with antimalarials used in rheumatic diseases (e. g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents (with the exception of methotrexate, see section 4.5) has not been studied up to now.
L- użu ta` leflunomide, flimkien mal- mediċini kontra l- malarja, użati fir- rewmatiżmu, (e. g. chloroquine u hydroxychloroquine), deheb li jingħata sew fil- muskoli kif ukoll mill- ħalq, D- penicillamine,
Since such therapy can lead to additive or even synergistic toxicity (e. g. hepato- or haematotoxicity), combination with another DMARD (e. g. methotrexate) is not advisable.
Peress li terapija bħal din tista ’ tkun addizjonali jew anke sinerġika fir - rigward tat- tossiċità (e. g. tossiċità għall- fwied u għad- demm), it- teħid flimkien ma ’ prodott ieħor tal - klassi tad- DMARD (e. g. methotrexate) mhux ta ’ min jirrakkomandah.
Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.
Huwa rrakomandat li tittieħed il- kawtela meta leflunomide jingħata flimkien ma ’ mediċina oħra, ħlief l- NSAIDs, li huma metaboliżżati minn CYP2C9 bħal phenytoin, warfarin, phenprocoumon u tolbutamide.
18 Switching to other treatments
Meta ssir il- bidla għal kuri oħra
Procreation (recommendations for men)
20 Prokreazzjoni (rakkomandazzjonijiet għall- irġiel)
Male patients should be aware of the possible male-mediated foetal toxicity Reliable contraception during treatment with leflunomide should also be guaranteed.
Miżuri kontraċettivi ta ’ min jorbot fuqhom waqt it- trattament b’ leflunomide għandhom ukoll ikunu garantiti.
There are no specific data on the risk of male-mediated foetal toxicity.
M’ hemmx tagħrif speċifiku fuq ir- riskju tat- tossiċità għall- fetu li tkun ġejja mill- missier.
In either case the A771726 plasma concentration is then measured for the first time.
Fiż- żewġ każijiet, il- livelli ta ’ A771726 fil- plażma jridu jitkejjlu fil- bidu.
19 Washout procedure
Il- proċedura biex jitneħħa leflunomide mill- ġisem
All of these also resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Anke dawn kienu riżolti, 2 bit- tkomplija tal- kura biż- żewġ sustanzi, waqt li fi 3 wara li twaqqaf leflunomide.
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/ or corticosteroids, these may be continued after starting leflunomide.
21 Jekk il- pazjent diġà qiegħed fuq is- sustanzi mhux sterojdi kontra l- infjammazzjoni (NSAIDs), u/ jew l - kortikosterojdi, dawn jistgħu jitkomplew wara li jinbeda leflunomide.
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.
Wara t- teħid konkomittanti ta ’ doża waħda ta ’ leflunomide, f’ pazjenti li kienu qed jieħdu dożi multipli ta` rifampicin (induttur 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.
In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 µg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
Fi studju fejn leflunomide ngħata flimkien mal- pillola kontraċettiva orali tat- tip ta ’ tlett fażijiet, li kellha 30 μg ethinyloestradiol, lill- voluntiera nisa b’ saħħithom, ma kienx hemm tnaqqis ta ’ l- effett kontraċettiv tal- pillola, u l- komportament farmakokinetiku ta ’ l- A771726 kien fil- limitu previst.
20 Vaccinations
Tilqim
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Il- prodott metaboliku attiv ta ’ leflunomide A771726 kien ihuwa maħsub li jista ’ jagħmel difetti serji tat- twelid meta jingħata waqt it- tqala.
Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “ waiting period” below) or up to 11 days after treatment (see abbreviated “ washout period” below).
In- nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa sentejn wara it - trattament (ara “ perijodu ta ’ stennija ” hawn isfel), jew sa 11- il jum wara l- kura (ara “ ż- żmien imqassar biex jitneħħa leflunomide ”, hawn isfel).
Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days.
22 Wara, il- livell ta ’ A771726 fil- plażma għandu jerġa ’ jkun iċċekkjat mhux inqas minn 14- il jum wara.
Washout procedure
Il- proċedura biex jitneħħa leflunomide
After stopping treatment with leflunomide:
Wara li leflunomide jitwaqqaf:
However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/ l and fertilisation is required.
Madankollu, anke wara li tintuża waħda minn dawn il- proċeduri ta ’ tneħħija, il- verifika b’ żewġ testijiet separati, magħmulin b’ intervall ta ’ mhux inqas minn 14- il jum, u perijodu ta ’ stennija ta ’ xahar u nofs mit- test li juri livell ta ’ inqas minn 0. 02 mg/ l, huwa meħtieġ qabel il- fertilizzazzjoni.
21 Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Nisa li jistgħu jkollhom it- tfal, għandhom ikunu avżati li ż- żmien ta ’ stennija huwa ta ’ sentejn wara li l- kura titwaqqaf u qabel ma jistgħu joħorġu tqal.
Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Studji fl- annimali - urew li leflunomide, jew il- prodotti metaboliċi tiegħu, jgħaddu fil- ħalib tas- sider.
22 Nervous system disorders
Disturbi fis- sistema nervuża
Rare: interstitial lung disease (including interstitial pneumonitis), which may be fatal.
Rari: disturbi ta ’ l- interstitium tal- pulmun (inkluża l- pulmonite interztizjali), li tista ’ tkun fatali
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
twaqqigħ tax- xagħar aktar minn normal, ekżema, raxx (jinkludi raxx ikkaratteriżżat minn titbigħ u ponot), ħakk, ġilda xotta
Very rare:
24 Rari ħafna:
Rare: severe infections, including sepsis which may be fatal.
Rari: infezzjonijiet severi, inkluż sepsis li tista ’ tkun fatali
Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Bħal sustanzi oħra li għandhom potenzjal immunosoppressiv, leflunomide jista ’ jżid is- suxxettibbiltà għall- infezzjonijiet, inklużi dawk opportunistiċi (ara wkoll sezzjoni 4. 4).
23 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
Immune system disorders
Disturbi fis- sistema
Reproductive system and breast disorders
Disturbi fis- sistema
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.
Intwera li t- teħid ta ’ charcoal 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 tal - prodott metaboliku attiv, A771726, b ’ 37% f’ 24 siegħa u b’ 48% f’ 48 siegħa.
24 Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Studji fuq id- dijaliżi tad- demm u pazjenti CAPD (dawk fuq saqajhom li qegħdin jagħmlu dijaliżi kronika mill- peritonew) juru li l- A771726, il- prodott metaboliku ewlieni ta ’ leflunomide, mhux dijaliżżabbli.
Mode of action
26 Il- mod kif jaħdem
The ACR (American College of Rheumatology) response rates in study YU203 were 27.7% for placebo, 31.9% for 5 mg, 50.5% for 10 mg and 54.5% for 25 mg/ day.
Ir- rati ta ’ rispons skond l- ACR (il- Kulleġġ Amerikan tar- Rewmatoloġija) fl- istudju YU203 kienu 27. 7% bil- plaċebo u 31. 9% b’ 5 mg, 50. 5% b’ 10 mg u 54. 5% b’ 25 mg, kuljum.
In 25 study MN302 leflunomide was significantly less effective than methotrexate.
Fl- istudju MN302 leflunomide kien anqas effettiv minn methotrexate b’ mod sinifikanti.
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories :< 20kg, 20-40 kg, and > 40kg.
27 ta ’ leflunomide, kienu mfassla għal tliet kategoriji, skond il- piż: < 20 kg, 20- 40 kg, u > 40 kg.
The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
Il- firxa tal- ġrajjiet avversi ta ’ leflunomide u methotrexate kienu l- istess, iżda d- doża użata fis- suġġetti ħfief fil- piż wasslet għall- espożizzjoni aktar baxxa (ara sezzjoni 5. 2).
Leflunomide can be administered with food, since the extent of absorption is comparable in the fed and fasting state.
Leflunomide jista ’ jingħata ma ’ l- ikel, għaliex l- ammont li ġie assorbit f’ dawk li kielu u f’ dawk li kienu sajmin kien komparabbli.
Due to the very long half-life of A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726.
Minħabba li A771726 għandu half- life twila ħafna (madwar ġimgħatejn), fi studji kliniċi, kienet mgħotija doża għolja tal- bidu ta ’ 100 mg, għal 3 ijiem, biex tiffaċilita l- kisba mgħaġġla ta ’ livelli, fi stat stabbli, ta ’ A771726.
In these studies, the clinical effect was
Fi studji b’ dożi multipli, f’ pazjenti li kellhom l- artrite rewmatika, il- parametri farmakokinetiċi ta ’ A771726 kienu linejari, f’ firxa ta ’ dożaġġ ta ’ minn 5 sa 25 mg.
26 closely related to the plasma concentration of A771726 and to the daily dose of leflunomide.
F’ dawn l- istudji, l- effett kliniku kien relatat sew mal- livell ta ’ A771726 fil- plażma u mad- doża ta ’ kuljum ta ’ leflunomide.
A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10% to 50%.
A771726 jisposta lil ibuprofen, lil diclofenac u lil
Pharmacokinetics in liver failure
Tagħrif farmakokinetiku fl- insuffiċjenza tal- fwied
27 Pharmacokinetics in paediatrics
Komportament farmakokinetiku fis- suġġetti pedjatriċi
Pharmacokinetics in elderly
29 Komportament farmakokinetiku fl- anzjani
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Madankollu, l- prodott metaboliku minuri, TFMA (4 - trifluoromethylaniline) ikkaġuna ksur u tħarbit tal- kromożomi, kif ukoll mutazzjonijiet dovuti għal bidla ta ’ par wieħed tan- nuklejtidi tad- DNA; fil- waqt li l- informazzjoni ma kienitx biżżejjed biex tixħet dawl fuq il- potenżjal biex ikun eżerċitat dan l- effett in vivo.
In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide.
Dan kien meqjus li kien minħabba l- attività immunosoppressiva ta ’ leflunomide.
In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Fil- ġrieden ta ’ sess femminil, kien hemm żieda fl- inċidenza ta ’ adenomi u kanċer tal- pulmun tat- tip bronkjolo- alvejolari, li kienu iddeterminati mid- doża użata.
The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain.
Ir - relevanza ta ’ dawn ir- reperti fil- ġrieden, relatati ma ’ l- użu kliniku ta ’ leflunomide, mhux magħruf b’ ċertezza.
Maize starch povidone (E1201) crospovidone (E1202) silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Maize starch povidone (E1201), rospovidone (E1202) silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Talc(E553b) 28 hypromellose (E464) titanium dioxide (E171) macrogol 8000 yellow ferric oxide (E172)
Talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 ferric oxide isfar (E172)
6.2 Incompatibilities
30 6. 2 Inkompatibilitajiet
Keep the container tightly closed.
Żomm il- kontenitur magħluq sew.
30, 50 and 100 film-coated tablets.
30, 50 u 100 pilloli miksija b’ rita.
02 September1999 Date of latest renewal:
02 ta ’ Settembru 1999 Data ta ’ l- aħħar tiġdid:
Arava 100 mg film-coated tablets
Arava 100 mg pilloli miksija b’ rita.
Each film-coated tablet contains 100 mg of leflunomide and 138.42 mg of lactose.
Kull pillola miksija b’ rita fiha 100 mg ta ’ leflunomide u 138. 42 mg ta ’ lactose.
White to almost white, round film-coated tablet with a diameter of about 1 cm, imprinted with ZBP on one side.
Pillola miksija b’ rita, bajda jew kważi bajda, tonda b’ dijametru ta ’ madwar 1 cm, stampata b’ ZBP fuq faċċata waħda
Leflunomide is indicated for the treatment of adult patients with: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), • active psoriatic arthritis.
Leflunomide huwa indikat għall- kura ta ’ pazjenti adulti li jbatu minn: • artrite attiva, tat- tip rewmatojde bħala “ mediċina antirewmatika li timmodifika l- marda ” (DMARD), • artrite psorjatika attiva.
Alanine Aminotransferase (ALT) (or serum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: • before initiation of leflunomide • every two weeks during the first six months of treatment, and • every 8 weeks thereafter (see also section 4.4).
Alanine aminotransferase (ALT) (jew serum glutamopyruvate transferase SGPT) u test komplut tad - demm, fejn jingħaddu ċ- ċelluli kollha, inklużi t- tipi diversi kollha taċ- ċelluli bojod u l- plejtlits, iridu jsiru simultanjament u bl- istess frekwenza: • qabel ma jinbeda leflunomide, • kull ġimgħatejn fl- ewwel sitt xhur tal- kura, u • kull 8 ġimgħat minn hemm ’ il quddiem (ara wkoll sezzjoni 4. 4).
30 Posology
32 Pożoloġija
Serious undesirable effects might occur (e. g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped.
Għalhekk, meta jkun
Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
33 hemm dawn l- effetti tossiċi, jew jekk għal xi raġuni oħra A771726 għandu jiġi mneħħi malajr mill - ġisem, il- proċedura li tneħħi din ta ’ l- aħħar mill- ġisem trid tkun segwita.
31 For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Għal dan il- għan, u xi miżuri oħra irrakkomandati f’ każ ta ’ tqala mixtieqa jew mhux ippjanata, ara sezzjoni 4. 6.
Since such therapy can lead to additive or even synergistic toxicity (e. g. hepato- or haematotoxicity), combination with another DMARD (e. g. methotrexate) is not advisable.
34 rigward tat- tossiċità (e. g. tossiċità għall- fwied u għad- demm), it- teħid flimkien ma ’ prodott ieħor tal - klassi tad- DMARD (e. g. methotrexate) mhux ta ’ min jirrakkomandah.
32 Switching to other treatments
Meta ssir il- bidla għal kuri oħra
It is known that medications with immunosuppressive properties - like leflunomide – may cause patients to be more susceptible to infections, including opportunistic infections.
Huwa magħruf li mediċini bħal leflunomide, li għandhom effetti immunosoppressivi, jagħmlu l - pazjent aktar soxxettibbli għall- infezzjonijiet, iklużi dawk opportunisti.
There are no specific data on the risk of male-mediated foetal toxicity.
35 M’ hemmx tagħrif speċifiku fuq ir- riskju tat- tossiċità għall- fetu li tkun ġejja mill- missier.
33 Washout procedure
Il- proċedura biex jitneħħa leflunomide mill- ġisem
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi rari u ereditarji t’ intolleranza għall- galaktosju, id- defiċjenza ta ’ l- enżima lactase tat- tip Lapp, jew il- malassorbiment tal- glukusju- galaktosju, m’ għandhomx jieħdu dan il - prodott mediċinali.
All elevations resolved 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Dawn il- livelli għoljin niżlu kollha, 2 minnhom meta tkomplew jingħataw iż- żewġ sustanzi, fil- waqt li fit- 3 l- oħra wara li twaqqaf leflunomide.
All of these also resolved 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Anke dawn kienu riżolti, 2 bit- tkomplija tal- kura biż- żewġ sustanzi, waqt li fi 3 wara li twaqqaf leflunomide.
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.
36 leflunomide, f’ pazjenti li kienu qed jieħdu dożi multipli ta` rifampicin (induttur 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.
34 Vaccinations
Tilqim
Arava is contraindicated in pregnancy(see section 4.3).
Arava m’ għandux jingħata waqt it- tqala (ara sezzjoni 4. 3).
Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “ waiting period” below) or up to 11 days after treatment (see abbreviated “ washout period” below).
In- nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa sentejn wara it - trattament (ara “ perijodu ta ’ stennija ” hawn isfel), jew sa 11- il jum wara l- kura (ara “ ż- żmien imqassar biex jitneħħa leflunomide ”, hawn isfel)
For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
37 Għal aktar informazzjoni fuq l- ittestjar tal- kampjuni, jekk jogħġbok ikkuntattja lid- Detentur ta ’ l - Awtorizzazzjonigħat- Tqegħid fis- Suq, jew ir- rappreżentant lokali tiegħu (ara sezzjoni 7).
35 Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Nisa li jistgħu jkollhom it- tfal, għandhom ikunu avżati li ż- żmien ta ’ stennija huwa ta ’ sentejn wara li l- kura titwaqqaf u qabel ma jistgħu joħorġu tqal.
The most frequently adverse effects reported commonly (≥ 1/ 100 to < 1/ 10) 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))
Ir- reazzjonijiet avversi l- aktar komunement (≥1/ 100 sa < 1/ 10) 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) Klassifika tal- frekwenzi mistennija:
Cardiac disorders
38 Disturbi tal- qalb
36 Nervous system disorders
Disturbi fis- sistema nervuża
Rare: interstitial lung disease (including interstitial pneumonitis), which may be fatal.
Disturbi ta ’ l- interstitium tal- pulmun (inkluża l- pulmonite interztizjali), li tista ’ tkun fatali
diarrhoea, nausea, vomiting, oral mucosal disorders (e. g., aphthous stomatitis, mouth ulceration), abdominal pain
dijarrea, tqalligħ, rimettar, Disturbi tal- mukuża fil- ħalq (e. g. stomatite bl- afte, ulċeri tal- ħalq), uġigħ addominali
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
in- nekrosi tossika u esfoljattiva tal- ġilda, eritema multiforme, is- sindrome ta ’ Stevens- Johnson, eritema multiforme
37 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
38 Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Studji fuq id- dijaliżi tad- demm u pazjenti CAPD (dawk fuq saqajhom li qegħdin jagħmlu dijaliżi kronika mill- peritonew) juru li l- A771726, il- prodott metaboliku ewlieni ta ’ leflunomide, mhux dijaliżżabbli.
Rheumatoid arthritis
41 Artrite rewmatika
In 39 study MN302 leflunomide was significantly less effective than methotrexate.
Fl- istudju MN302 leflunomide kien anqas effettiv minn methotrexate b’ mod sinifikanti.
The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
42 Il- firxa tal- ġrajjiet avversi ta ’ leflunomide u methotrexate kienu l- istess, iżda d- doża użata fis- suġġetti ħfief fil- piż wasslet għall- espożizzjoni aktar baxxa (ara sezzjoni 5. 2).
40 closely related to the plasma concentration of A771726 and to the daily dose of leflunomide.
F’ dawn l- istudji, l- effett kliniku kien relatat sew mal- livell ta ’ A771726 fil- plażma u mad- doża ta ’ kuljum ta ’ leflunomide.
Metabolism
43 Metaboliżmu
41 Pharmacokinetics in paediatrics
Komportament farmakokinetiku fis- suġġetti pedjatriċi
5.3 Preclinical safety data
44 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Maize starch povidone (E1201) crospovidone (E1202) talc (E553b) silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Maize starch povidone (E1201) crospovidone (E1202) talc (E553b) silica colloidal anhydrous magnesium stearate (E470b), lactose monohydrate
42 Film-coating:
Ir- rita tal- pillola:
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000.
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000
Pack size:
Daqst tal- pakkett:
3 film-coated tablets.
3 pilloli miksija b’ rita.
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott:
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiegne Cedex Franza
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness 1:
The marketing authorisation holder should submit 12-monthly PSURs.
Id- detentur ta ’ l- awtorizzazzjoni tal- manifattura għandu jissottometti PSURs kull 12- il xahar.
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA’ BARRA/ FOLJA
Arava 10 mg film-coated tablets Leflunomide
Arava 10 mg pilloli miksija b’ rita Leflunomide
Each film-coated tablet contains 10 mg leflunomide.
Kull pillola miksija b’ rita fiha 10 mg leflunomide.
This medicinal product contains lactose (see leaflet for further information).
Dan il- prodott mediċinali fih il- lactose (ara l- fuljett ta ’ tagħrif għal aktar informazzjoni).
30 film-coated tablets 100 film-coated tablets
30 pilloli miksija b’ rita 100 pilloli miksija b’ rita
Oral use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu orali
SPECIAL STORAGE CONDITIONS
9 KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Ġermanja
EU/ 1/ 99/ 118/ 001 30 tablets EU/ 1/ 99/ 118/ 002 100 tablets
EU/ 1/ 99/ 118/ 001 30 pilloli EU/ 1/ 99/ 118/ 002 100 pilloli
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA’ BARRA/ FLIXKUN
Keep the container tightly closed
Żomm il- kontenitur magħluq sewwa.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH
EU/ 1/ 99/ 118/ 003 30 tablets EU/ 1/ 99/ 118/ 004 100 tablets
EU/ 1/ 99/ 118/ 003 30 pilloli EU/ 1/ 99/ 118/ 004 100 pilloli
52 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
INNER LABEL/ BOTTLE PACK
TIKKETTA TA ’ ĠEWWA / FLIXKUN
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA TIKKETTA TA ’ BARRA / FOLJA
Arava 20 mg film-coated tablets Leflunomide
Arava 20 mg pilloli miksija b’ rita Leflunomide
Each film-coated tablet contains 20 mg leflunomide.
Kull pillola miksija b’ rita fiha 20 mg ta ’ leflunomide.
This medicinal product contains lactose (see leaflet for further information).
Dan il- prodott mediċinali fih il- lactose (ara l- fuljett għal aktar informazzjoni).
EU/ 1/ 99/ 118/ 005 30 tablets EU/ 1/ 99/ 118/ 006 100 tablets
EU/ 1/ 99/ 118/ 005 30 pilloli EU/ 1/ 99/ 118/ 006 100 pilloli
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA/ FLIXKUN
30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
30 pilloli miksija b’ rita 50 pilloli miksija b’ rita 100 pilloli miksija b’ rita
EU/ 1/ 99/ 118/ 007 30 tablets EU/ 1/ 99/ 118/ 010 50 tablets EU/ 1/ 99/ 118/ 008 100 tablets
EU/ 1/ 99/ 118/ 007 30 pilloli EU/ 1/ 99/ 118/ 010 50 pilloli EU/ 1/ 99/ 118/ 008 100 pilloli
Medicinal product subject to medical prescription.
- Prodott mediċinali jingħata bir- riċetta tat- tabib.
59 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/ BLISTER PACK
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA/ FOLJA
Arava 100 mg film-coated tablets Leflunomide
Arava 100 mg pilloli miksija b’ rita Leflunomide
Each film-coated tablet contains 100 mg leflunomide.
Kull pillola miksija b’ rita fiha 100 mg ta ’ leflunomide.
3 film-coated tablets
3 pilloli miksija b’ rita
Store in the original package
Żomm fil- pakkett oriġinali.
EU/ 1/ 99/ 118/ 009 3 tablets
EU/ 1/ 99/ 118/ 009 3 pilloli
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
66 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
65 PACKAGE LEAFLET:
68 FULJETT TA ’ TAGĦRIF:
please tell your doctor or pharmacist
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Arava is and what it is used for 2.
X’ inhu Arava u għalxiex jintuża 2.
Before you take Arava 3.
Qabel ma tieħu Arava 3.
How to take Arava 4.
Kif għandek tieħu Arava 4.
How to store Arava 6.
Kif taħżen Arava 6.
WHAT ARAVA IS AND WHAT IT IS USED FOR
X’ INHU ARAVA U GĦALXIEX JINTUŻA
Arava belongs to a group of medicines called anti-rheumatic medicines.
Arava jappartjeni għall- grupp ta ’ mediċini msejħa antirewmatiċi.
Arava is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Arava huwa wżat biex jittratta pazjenti adulti b’ artrite rewmatojde attiva jew b’ artrite psorjatika attiva.
Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain.
Is- sintomi ta ’ l- artrite rewmatika jinkludu infjammazzjoni tal- ġogi, nefħa, diffikultà fil- movimenti u uġigħ.
Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells).
Sintomi oħra li jistgħu jeffettwaw il- ġisem kollu huma n- nuqqas t’ aptit, id- deni, nuqqas ta ’ enerġija u anemija (nuqqas ta ’ taċ- ċelluli ħomor tad- demm).
Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Is- sintomi ta ’ l- artrite psorjatika jinkludu infjamazzjoni tal- ġogi, nefħa, diffikultà fil- movimenti, uġigħ u ġilda bi rqajja ’ ħomor u bil- qxur (leżjonijiet tal- ġilda).
BEFORE YOU TAKE ARAVA
QABEL MA TIEĦU ARAVA
Do not take Arava
Tieħux Arava
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
- jekk qatt kellek xi reazzjoni allerġika għal leflunomide (speċjalment xi reazzjoni serja tal -
often accompanied by fever, joint pain, red skin stains, or blisters e. g.
ġilda, spiss akkompanjata bid- deni, uġigħ fil- ġogi, tbajja ’ ħomor tal- ġilda, jew infafet e. g. is - sindrome ta ’ Stevens- Johnson) jew għal xi wieħed mill- ingredjenti l- oħra ta ’ Arava,
Steven-Johnson syndrome) or to any of the other ingredients of Arava, if you have any liver problems,
- jekk għandek xi problemi fil- fwied
- if you have moderate to severe kidney problems,
- jekk għandek xi problemi fil- kliewi ta ’ grad moderat jew sever,
- if you have severely low numbers of proteins in your blood (hypoproteinaemia),
- jekk għandek livelli baxxi ħafna tal- proteini fid- demm (livelli baxxi ħafna tal- proteini fid -
- if you suffer from any problem which affects your immune system (e. g.
- jekk tbati minn xi problemi li taffettwalek id- difiża ta ’ l- immunità tiegħek (e. g.
- if you have any problem with your bone marrow, or if you have low numbers of red or white
- jekk għandek problema bil- mudullun tiegħek, jew jekk għandeknumru baxx ta ’ ċelluli ħomor
cells in your blood or a reduced number of blood platelets,
jew bojod fid- demm tiegħek, jew tnaqqis fin- numru ta ’ plejtlits fid- demm,
- if you are suffering from a serious infection,
- jekk qiegħed issofri minn xi infezzjoni serja,
- if you are pregnant or breast-feeding.
- jekk inti tqila jew qiegħda tredda ’.
Take special care with Arava
Oqgħod attent ħafna b’ Arava
- if you have ever suffered from tuberculosis (a lung disease),
- jekk qatt kellek it- tuberkulosi (marda tal- pulmun).
- if you are male and wish to father a child, as Arava can cause birth defects in new born infants.
- jekk int pazjent raġel u tixtieq li jkollok it- tfal, billi l- Arava jista ’ jikkawża diffetti tat- twelid fit -
To minimise any possible risk, men wishing to father a child should contact their doctor who may advise you to stop taking Arava and take certain medicines to speed up the removal of 66 Arava from your body.
69 Biex jitnaqqas kull riskju possibbli, dawk l- irġiel li jixtiequ jkollhom it- tfal għandhom ikellmu lit- tabib li għandu/ ha mnejn j/ tagħtik parir biex twaqqaf l- Arava u tieħu ċerti mediċini biex iħaffu t- tneħħija ta ’ Arava minn ġismek.
You will then need a blood test to make sure that Arava has been sufficiently removed from your body, and you should then wait for at least another 3 months.
Ikollok bżonn ta ’ test tad- demm biex tiżgura li l - Arava tneħħa biżżejjed minn ġo ġismek u, wara dan, għandek tistenna għal mhux inqas minn 3 xhur oħra.
Arava can occasionally cause some problems with your blood, liver or lungs.
Kultant,, l- Arava jista ’ jikkawża xi problemi fid- demm, fil- kliewi u fil- pulmun.
It may also cause some serious allergic reactions, or increase the chance of a severe infection.
Jista ’ ukoll jikkawżaxi reazzjonijiet allergiċi severi, jew jiżdied iċ- ċans ta xi infezzjoni severa.
For more information on these, please read section 4 (Possible Side Effects).
Għal aktar informazzjoni fuq dawn il- problemi, jekk jogħhġbok aqra sezzjoni 4 (Effetti Sekondarji li jista ’ Jkollu)
Your doctor will carry out blood tests at regular intervals, before and during treatment with Arava, to monitor your blood cells and liver.
It- tabib tiegħek sejjer jagħmillek it- testijiet tad- demm f’ intervalli regolari, qabel u waqt it- trattament bl- Arava, biex jimmoniterja ċ- ċelluli tad- demm u l- fwied tiegħek.
Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
It- tabib tiegħek għandu jiċċekkja ukoll il- pressjoni tad- demm tiegħek regolarment għax Arava tista ’ żżid il- pressjoni.
Arava is not recommended for use in children and adolescents below 18 years of age.
Arava mhux irrakkomandat għall- użu fi tfal u adoloxxenti taħt it- 18- il sena.
This is especially important if you are taking:
Dan huwa importanti speċjalment jekk qiegħed tieħu:
- other medicines for rheumatoid arthritis such as antimalarials (e. g. chloroquine and
- mediċini oħra għall- artrite rewmatika bħal mediċini kontra l- malarja (e. g. chloroquine u
hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e. g. methotrexate) as these combinations are not advisable,
hydroxychloroquine), deheb li jingħata sew fil- muskoli kif ukoll mill- ħalq, D- penicillamine, azathioprine u mediċini oħra li jrażżnu l- istat immuni (e. ż. methotrexate), billi dawn il- prodotti nflimkien mhumiex irrakkomandati.
- a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as
- mediċina msejjaħ colestyramine (użat fil- kura ta ’ livelli għolja tax- xaħam fid- demm) u
these medicines can reduce the amount of Arava which is absorbed by the body,
charcoal mediċinali attivat billi dawn il- mediċini jistgħu naqqsu l- ammont ta’ Arava li huma assorbiti mill- ġisem.
- phenytonin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or
- phenytoin (jintuża biex jittratta l- epilessija), warfarin u phenprocoumon (jintuża biex iraqqa ’
tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
d- demm) jew tolbutamide (jintuża biex jittratta dijabete mellitus tat- tip 2) billi dawn il - mediċini jistgħu żiedu r- riskju ta ’ l- effetti sekondarji
If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/ or corticosteroids, you may continue to take them after starting Arava.
Jekk inti diġa ’ qiegħed tieħu l- mediċina mhux sterojdi li jintużaw kontra l- infjammazzjoni (NSAIDs u/ jew corticosteroids, dawn jistgħu jitkomplew wara li jinbeda Arava.
Vaccinations If you have to be vaccinated, ask your doctor for advice.
Tilqim Jekk inti għandek bżonn titlaqqam, staqsi lit- tabib tiegħek għal- parir.
Certain vaccinations should not be given while taking Arava, and for a certain amount of time after stopping treatment.
Ċerta tilqim b’ vaċċini m’ għandux isir waqt li qed tieħu Arava, u għal xi żmien wara li titwaqqaf l- kura.
Taking Arava with food and drink It is not recommended to drink alcohol during treatment with Arava.
Meta tieħu Arava ma ’ l- ikel u x- xorb Mhux irrakkomandat li tixrob l- alkoħol waqt il- kura b’ Arava.
Drinking alcohol while taking Arava may increase the chance of liver damage.
Jekk tixrob l- alkoħol waqt li qiegħed fuq Arava tista ’ iżied iċ- ċans ta ’ ħsara fil- fwied.