FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses.
Maltese: Nevanac fih il-klorur tal-benzalkonju, magħruf li jibdel il-kulur tal-lentijiet ta' kuntatt rotob.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nevanac fil-11 ta' Diċembru 2007.
English: By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.
Maltese: Billi tnaqqas il-produzzjoni tal-prostaglandini fl-għajn, Nevanac jista' jnaqqas il-komplikazzjonijiet ikkawżati mill-kirurġija fl-għajn, bħall-infjammazzjoni, l-uġigħ u nnefħa.
English: The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.
Maltese: Il-kumpanija wettqet ukoll studji biex turi li Nevanac 3 mg/ml meta jingħata darba kuljum kien aktar effettiv mill-plaċebo u kellu l-istess effett fil-prevenzjoni u l-kura tal-uġigħ u l-infjammazzjoni bħal Nevanac 1 mg/ml li jingħata tliet darbiet kuljum.
English: What is the risk associated with Nevanac?
Maltese: X'inhu r-riskju assoċjat ma' Nevanac?
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Maltese: Din taħdem billi timblokka l-enżima msejħa ċiklooksiġenażi, li tipproduċi l-prostaglandini, sustanzi involuti fil-proċess ta' infjammazzjoni.
English: One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
Maltese: Studju minnhom qabbel l-uża ta' darba, darbtejn jew tliet darbiet ta' Nevanac 1 mg/ml ma' plaċebo (kura finta) f'220 pazjent.
English: In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
Maltese: Fl-istudju li qabbel Nevanac mal-ketorolak, madwar 65% taż-żewġ gruppi ta' pazjenti wrew ftit jew xejn sinjali ta' infjamazzjoni.
English: The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml.
Maltese: L-ewwel studju ewlieni uża Nevanac 1mg/ml filwaqt li ż-żewġ studji ewlenin loħra użaw Nevanac 3 mg/ml.
English: In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema.
Maltese: F'pazjenti li jbatu bid-dijabete, Nevanac kien aktar effettiv mill-plaċebo fit-tnaqqis tar-riskju tal-edema makulari.
English: Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Maltese: Bħal NSAIDs oħra, Nevanac ma għandux jintuża f'pazjenti li fil-passat kellhom attakk tal-ażma, ħorriqija jew infjammazzjoni tal-passaġġi nażali meta ħadu laspirina jew NSAIDs oħra.
English: Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Maltese: Il-kura għandha tinbeda jum wieħed qabel l-intervent kirurġiku tal-katarretti.
English: Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema.
Maltese: Il-kura titkompla wara lintervent kirurġiku għal ġimagħtejn jew tliet ġimgħat meta tkun qed tingħata biex tipprevjeni l-uġigħ jew l-infjammazzjoni, jew sa mhux aktar minn 60 jum meta tkun qed tingħata biex tnaqqas ir-riskju ta' edema makulari.
English: called Viread.
Maltese: Viread.
English: Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI).
Maltese: Tenofovir huwa inibitur nukleotidiku tat-transkriptażi inversa (NRTI).
English: The full EPAR for Tenofovir disoproxil Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Tenofovir disoproxil Mylan jinsab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Maltese: Tenofovir disoproxil Mylan fih is-sustanza attiva tenofovir disoproxil.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Maltese: Tenofovir jinterferixxi wkoll mal-azzjoni ta' enzima prodotta mill-virus tal-epatite B li tissejjaħ "polimerażi tad-DNA", li hija involuta fil-formazzjoni ta' DNA virali.
English: Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Tenefovir disoproxil Mylan jintuża biex jikkura l-adulti u l-adolexxenti minn 12-il sena 'l fuq li huma infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża s-sindromu millimmunodefiċjenza akkwiżita (AIDS).
English: Other information about Tenofovir disoproxil Mylan
Maltese: Informazzjoni oħra dwar Tenofovir disoproxil Mylan
English: In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI).
Maltese: Fl-adolexxenti (minn 12 sa 18-il sena) l-użu tiegħu huwa biss għal dawk li ma jistgħux jingħataw kura b'inibituri nukleotidiċi oħra tat-traskriptażi inversa (NRTIs) tal-ewwel linja.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tenofovir disoproxil Mylan.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Maltese: Fl-infezzjoni tal-HIV, dan jimblokka l-attività tat-transkriptażi inversa, enzima prodotta mill-HIV li tħalliha tipproduċi lilha nnifisha fiċ-ċelluli li tkun infettat.
English: The active substance in this medicine, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Maltese: Is-sustanza attiva f'din il-mediċina, it-tenofovir disoproxil, hi "prodroga" li fil-ġisem tinbidel f'tenofovir.
English: Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age.
Maltese: Tenofovir disoproxil Mylan jintuża wkoll biex jikkura infezzjoni tal-virus tal-epatite B kronika (fit-tul) fladulti u fl-adolexxenti minn 12-il sena 'l fuq.
English: Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Maltese: Minħabba li Tenofovir disoproxil Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Viread.
English: Tenofovir disoproxil Mylan is used in combination with other HIV medicines.
Maltese: Tenofovir disoproxil Mylan jintuża f'kombinazzjoni ma' mediċini oħra kontra l-HIV.
English: Why is Tenofovir disoproxil Mylan approved?
Maltese: Għaliex ġie approvat Tenofovir disoproxil Mylan?
English: Because Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Tenofovir disoproxil Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Maltese: Il-kumpanija li tqiegħed Tenofovir disoproxil Mylan fis-suq ser tiżgura li t-tobba kollha li huma mistennija jippreskrivu jew jużaw il-mediċina jingħataw materjal edukattiv li jkun fih informazzjoni importanti dwar is-sigurtà, partikolarment dwar ir-riskji u l-prekawzjonijiet relatati mal-funzjoni talkliewi u tal-għadam.
English: In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Maltese: Fl-adulti, jista' jintuża wkoll f'dawk il-pazjenti li l-fwied tagħhom saritlu l-ħsara u ma jkunx qed jiffunzjona kif suppost (mard tal-fwied dekumpensat) u f'dawk il-pazjenti li ma jirrispondux għall-kura b'lamivudina (mediċina oħra kontra l-epatite B).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Tenofovir disoproxil Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Viread.
English: Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.
Maltese: Tenofovir disoproxil Mylan iwaqqaf lill-virus milli jipproduċi DNA u ma jħallihx jimmultiplika u jinfirex.
English: What are the benefits and risks of Tenofovir disoproxil Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Tenofovir disoproxil Mylan?
English: Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Tenofovir disoproxil Mylan ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u jevita liżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth.
Maltese: Tenofovir disoproxil Mylan jiġi bħala pilloli (245 mg) li għandhom jittieħdu mill-ħalq.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Maltese: Għal pazjenti li qabel ikunu ħadu mediċini għall-kura tal-infezzjoni tal-HIV, it-tobba għandhom jippreskrivu Tenofovir disoproxil Mylan biss wara li jkunu eżaminaw il-mediċini antivirali li l-pazjent ikun ħa qabel jew wara li jkunu eżaminaw il-probabbiltà li l-virus jirrispondi għal mediċini antivirali.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Mylan?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Tenofovir disoproxil Mylan?
English: The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function.
Maltese: Jista' jkun li d-doża tkun teħtieġ li titnaqqas jew li l-mediċina tingħata inqas ta' spiss f'pazjenti bi tnaqqis moderat jew sever fil-funzjoni tal-kliewi.
English: Immediate Packaging
Maltese: Pakkett
English: NSAIDS/Corticosteroids
Maltese: NSAIDS/ Kortikosterojdi
English: Yellow ferric oxide (E172)
Maltese: Ferric oxide isfar (E172)
English: This metabolite is responsible for essentially all the in vivo activity of Arava.
Maltese: Dan il-prodott metaboliku huwa essenzjalment responsabbli għall-attivita kollha in vivo ta' Arava.
English: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany
Maltese: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Il-Ġermanja
English: Arava contains lactose.
Maltese: Arava fih il lactose.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: in-nekroliżi tossika tal-ġilda, eritema multiforme, is-sindrome ta' Stevens-Johnson, eritema multiforme
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti,, ara sezzjoni 6.1.
English: • Patients with serious infections (see section 4.4).
Maltese: • Pazjenti b'infezzjonijiet severi, (ara sezzjoni 4.4),
English: Other medicines and Arava
Maltese: Mediċini oħra u Arava
English: Date of first authorisation: 02 September 1999 Date of latest renewal: 02 September 2009
Maltese: Data tal-ewwel awtorizzazzjoni: 02 ta' Settembru 1999 Data tal-aħħar tiġdid: 02 ta' Settembru 2009
English: Metabolism and nutrition disorders Common:
Maltese: Disturbi fil- metaboliżmu u n-nutrizzjoni Komuni:
English: Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Maltese: Silica colloidal anhydrous Magnesium stearate (E470b),
English: 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.
Maltese: Ir-rati ta' rispons skont 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.
English: Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Maltese: Dożi ripetuti ta' A771726 naqqsu l-medja tas-Cmax u l-AUC ta' kaffeina (substrat ta' CYP1A2) bi 18% u 55%, rispettivament, u dan jissuġġerixxi li A771726 jista' jkun stimulatur dgħajjef ta' CYP1A2 in vivo.
English: severe infections, including sepsis which may be fatal.
Maltese: Infezzjonijiet u infestazzjonijiet Rari: infezzjonijiet severi, inkluż sepsis li tista' tkun fatali
English: • colestyramine 8 g is administered 3 times daily for a period of 11 days,
Maltese: • jingħata 8 g colestyramine 3 darbiet kuljum għall-perijodu ta' 11-il jum
English: • For psoriatic arthritis: 20 mg Arava once daily.
Maltese: • Għall-artrite psorjatika: 20 mg Arava darba kuljum.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Maltese: Kien hemm żieda fil-medja tas-Cmax u l-AUC (2.65 u 2.51 darbiet, rispettivament) ta' rosuvastatin, wara l-għoti ta' dożi ripetuti ta' A771726.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide 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 jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Maltese: Disturbi ta' l-interstitium tal-pulmun (inkluża l-pulmonite interztizjali), li tista' tkun fatali
English: A pharmacodynamics interaction with warfarin was observed with A771726 in a clinical pharmacology study (see below).
Maltese: Kienet osservata interazzjoni farmakodinamika bejn warfarin u A771726 f'studju ta' farmakoloġija klinika (ara aktar 'l isfel).
English: Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Maltese: Leflunomide, f'doża ta' mhux inqas minn 10 mg kuljum (minn 10 sa 25 mg fl-istudju YU203, 20 mg fl-istudji MN301 u US301), kien superjuri għall-plaċebo, u statistikament sinifikanti, fit-tnaqqis tassinjali u s-sintomi ta' l-artrite rewmatika fit-3 provi kollha ikkontrollati bil-plaċebo.
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies 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 skont 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: pulmonary hypertension Gastrointestinal disorders Common:
Maltese: Mhux magħruf: ipertensjoni pulmonarja Disturbi gastro-intestinali
English: agranulocytosis
Maltese: Il-Ġermanja
English: Effect on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Maltese: L-effett fuq substrati tat-trasportatur tal-anjoni organiċi 3 (OAT3) Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.43 u 1.54 darbiet rispettivament) ta' cefaclor, wara lgħoti ta' dożi ripetuti ta' A771726, u dan jissuġġerixxi li A771726 hu inibitur ta' OAT3 in vivo.
English: • In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Maltese: • Fl-artrite rewmatika: normalment, it-terapija b'leflunomide tibda b'doża ta' kkargar ta' 100 mg darba kuljum għal tlitt ijiem.
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%
English: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 µg/ml.
Maltese: F'doża ta' 20 mg kuljum, il-livell medju fil-plażma ta' A771726 fi stat stabbli kien ta' madwar 35 g/ml.
English: 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
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 pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 paediatric 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: severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari:
English: Arava is contraindicated in pregnancy(see section 4.3).
Maltese: Arava m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: Arava 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Arava 20 mg
English: Animal pharmacology
Maltese: 5. PROPRJETAJIET FARMAKOLOGIĊI
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 rewmatika attiva 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: colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
Maltese: kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenuża, dijarea, tqalligħ, rimettar, Disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali
English: Arava 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Arava 100 mg
English: Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Maltese: Għalhekk, meta jingħata flimkien ma' substrati ta' OAT3, bħal cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate u zidovudine, il-kawtela hi rrakkomandata.
English: Arava 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Arava 10 mg
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1).
Maltese: Id-doża irrakkomandata ta' manteniment hija ta' 20 mg ta' leflunomide darba kuljum (ara sezzjoni 5.1).
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
Maltese: Fl-istudju US301, tqassmu, mingħajr għażla, 482 pazjent bl-artrite rewmatika attiva fi tliet gruppi: dawk li ngħataw 20 mg leflunomide kuljum (n = 182), dawk li ingħataw 7.5 mg methotrexate filġimgħa b'żieda għall-15 mg fil-ġimgħa (n = 182) u dawk bil-plaċebo (n = 118).
English: Arava with food, drink and alcohol
Maltese: Arava ma' ikel, xorb u alkoħol
English: Repeated doses of A771726 had no effect on the pharmacokinetics of S-warfarin, indicating that A771726 is not an inhibitor or an inducer of CYP2C9.
Maltese: Dożi ripetuti A771726.ma kellhom l-ebda effett fuq il-farmakokinetika ta' warfarin S, u dan jindika li A771726. mhuwiex inibitur jew stimulatur ta' CYP2C9.
English: Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92).
Maltese: Dawn kienu mqassmin, mingħajr għazla, fi tlett gruppi: dawk li ngħataw 20 mg leflunomide kuljum (n = 133), dawk li ngħataw 2 g sulphasalazine kuljum (n = 133) jew il-plaċebo (n = 92).
English: The efficacy of Arava 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' Arava 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: 5.2 Pharmacokinetic properties
Maltese: 5.3 Tagħrif farmakokinetiku
English: In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg.
Maltese: 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.