FrancophonIA/ELRC3.0 huggingface dataset:
English: The referral relates to the divergent national decisions taken by Member States, raised by Germany.
Maltese: Ir-referenza hija relatata mad-deċiżjonijiet nazzjonali diverġenti meħudin minn Stati Membri, imqajma mill-Ġermanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: Pigs Broilers Calves
Maltese: Ħnieżer Brojlers Għoġiela
English: Poultry (except laying hens) Turkeys
Maltese: Tjur (minbarra tiġieġ li jbidu) Dundjani
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
English: The highest mean tilmicosin concentration detected for lung tissues was 2.19 µg/g at 6 days; for air sac tissue it was 4.18 µg/g at 2 days and in the plasma it was 0.172 µg/g at 3 days.
Maltese: L-ogħla konċentrazzjoni medja ta' tilmikosina li nstabet għat-tessut tal-pulmun kienet 2.19 µg/g wara 6 ijiem; għat-tessut talborża tal-arja kienet 4.18 µg/g wara jumejn u fil-plażma kienet 0.172 µg/g wara 3 ijiem.
English: Poultry: As early as 6 hours after oral administration of 75 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung and alveolar tissue were 0.63 µg/g and 0.30 µg/g respectively.
Maltese: Diġà minn 6 sigħat wara l-amministrazzjoni orali ta' 75 mg tilmikosina/l ta' ilma tax-xorb, ilkonċentrazzjonijiet tas-sustanza attiva li nstabu fit-tessut tal-pulmun u f'dak alveolari kienu 0.63 µg/g u 0.30 µg/g rispettivament.
English: Pigs: To be included in the drinking water to provide a daily dose of 15-20 mg/kg bodyweight for 5 days, which may be achieved by the inclusion of 200 mg tilmicosin per litre (80 ml Pulmotil AC per 100 litres).
Maltese: Għandu jkun inkluż fl-ilma tax-xorb sabiex jipprovdi doża ta' kuljum ta' 15-20 mg/kg piż tal-ġisem għal 5 ijiem, li tista' tinkiseb bl-inklużjoni ta' 200 mg tilmikosina kull litru (80 ml Pulmotil AC kull 100 litru).
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Maltese: L-evidenza xjentifika tissuġġerixxi li l-makrolidi jaġixxu b'mod sinerġiku mas-sistema immunitarja ospitanti.
English: CVMP accepts that a claim for efficacy at a dose of 15-20 mg/kg bodyweight for 5 days, which may be achieved by the inclusion of 200 mg tilmicosin per litre for treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin has been demonstrated.
Maltese: Is-CVMP jaċċetta li l-affermazzjoni għall-effikaċja f'doża ta' 15-20 mg/kg piż tal-ġisem għal 5 t'ijiem, li tista' tinkiseb bl-inklużjoni ta' 200 mg tilmicosin għal kull litru għall-kura u l-prevenzjoni ta' mard respiratorju fil-merħliet tal-ħnieżer, assoċjat ma' Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae u organiżmi oħrajn suxxettibbli għal tilmicosin, intweriet.
English: The CVMP accepts that a claim for efficacy at a dose of 12.5 mg/kg bodyweight (twice a day) for 5 days for the treatment and prevention of bovine respiratory disease, associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar has been demonstrated.
Maltese: Is-CVMP jaċċetta li l-affermazzjoni għall-effikaċja f'doża ta' 12.5 mg/kg piż tal-ġisem (darbtejn kuljum) għal 5 t'ijiem għall-kura u l-prevenzjoni ta' mard respiratorju tal-ifrat, assoċjat ma' Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar intweriet.
English: The CVMP recommends that further changes to the SPC proposed by the Marketing Authorisation Holders are made:
Maltese: Is-CVMP jirrakkomanda li jsiru bidliet oħrajn fl-SPC proposti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Calves: For the treatment and prevention of bovine respiratory disease, associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar and other organisms susceptible to tilmicosin.
Maltese: ¾ Għoġiela: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis u M. dispar.
English: One 240 ml bottle and 960 ml bottle of Pulmotil AC are sufficient to medicate in milk replacer respectively 12 to 20 and 48 to 80 veal calves each of 40 kg bodyweight depending on the duration of treatment.
Maltese: Flixkun wieħed ta' 240 ml u ta' 960 ml ta' Pulmotil AC huma biżżejjed biex jikkuraw fis-sostitut talħalib rispettivament 12 sa 20 u 48 sa 80 għoġol tal-vitella kull wieħed b'piż tal-ġisem ta' 40 kg skont kemm iddum il-kura.
English: Tilmicosin is a semi-synthetic antibiotic of the macrolide group and is believed to affect protein synthesis.
Maltese: It-tilmikosina hija antibijotiku semisintetiku tal-grupp makrolidi u hija maħsuba li taffettwa s-sinteżi tal-proteini.
English: Cattle
Maltese: Tjur:
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Kwalitajiet farmakokinetiċi
English: Chickens Turkeys
Maltese: Ir-Repubblika Ċeka
English: The CVMP has assessed a dose determination studies and four clinical study reports in turkeys
Maltese: Is-CVMP ivvaluta studju ta' determinazzjoni tad-doża u erba' rapporti ta' studji kliniċi fid-dundjani
English: Calves: As early as 6 hours after oral administration of 25 mg tilmicosin/kg body weight/day in milk replacer, an average active substance concentration of 3.1 µg/g was detected in lung tissue.
Maltese: Għoġiela: Diġà minn 6 sigħat wara l-amministrazzjoni orali ta' 25 mg tilmikosina/kg piż talġisem/kuljum fis-sostitut tal-ħalib, instabet konċentrazzjoni medja tas-sustanza attiva ta' 3.1 µg/g fittessut tal-pulmun.
English: Chickens and Turkeys (except hens producing eggs for human consumption): To be included in the drinking water at a daily dose of 15-20 mg/kg bodyweight in chickens and 10-27 mg/kg bodyweight in turkeys for 3 days, which may achieved by the inclusion of 75 mg tilmicosin per litre (30 ml Pulmotil AC per 100 litres).
Maltese: Tiġieġ u Dundjani (ħlief għal tiġieġ li jipproduċu l-bajd għall-konsum mill-bniedem): Għandu jkun inkluż fl-ilma tax-xorb f'doża ta' kuljum ta' 15-20 mg/kg piż tal-ġisem fit-tiġieġ u 10-27 mg/kg piż tal-ġisem fid-dundjani għal 3 ijiem, li tista' tinkiseb bl-inklużjoni ta' 75 mg tilmikosina kull litru (30 ml Pulmotil AC kull 100 litru).
English: Pulmotil AC 250 mg/ml concentrate for oral solution is currently registered in 18 European Member States.
Maltese: Pulmotil AC 250 mg/ml konċentrat għal soluzzjoni orali fil-preżent huwa rreġistrat fi 18-il Stat Membru Ewropew.
English: The CVMP has assessed two early dose determination studies, two definitive dose determination studies and eleven clinical study reports in pigs.
Maltese: Is-CVMP ivvaluta żewġ studji bikrija ta' determinazzjoni tad-doża, żewġ studji definittivi ta' determinazzjoni tad-doża u ħdax-il rapport ta' studji kliniċi fil-ħnieżer.
English: In case of accidental eye contact, flush the eyes with plenty of clean, running water.
Maltese: F'każijiet rari ħafna, ġie osservat tnaqqis fit-teħid tal-ilma.
English: No symptoms of overdose have been seen in chickens given drinking water containing levels of tilmicosin up to 375 mg/litre (equivalent to 75-100 mg/kg bodyweight or 5 times the recommended dose) for 5 days; daily treatment with 75 mg/litre (equivalent to the maximum recommended dose) for 10 days resulted in a reduction in faecal consistency.
Maltese: Ma deher l-ebda sintomu ta' doża eċċessiva fit-tiġieġ li ngħataw ilma tax-xorb li kien fih livelli ta' tilmikosina sa 375 mg/litru (ekwivalenti għal 75-100 mg/kg piż tal-ġisem jew 5 darbiet id-doża rakkomandata) għal 5 jiem; kura ta' kuljum b'75 mg/litru (ekwivalenti għad-doża massima rakkomandata) għal 10 ijiem irriżultat fi tnaqqis fil-konsistenza tal-feċi.
English: Tilmicosin has been shown to inhibit in vitro the replication of the Porcine Reproductive and Respiratory Syndrome virus in alveolar macrophages in a dose dependent fashion.
Maltese: It-tilmikosina wriet li tinibixxi in vitro ir-replikazzjoni tal-virus tas-Sindromu Riproduttiv u Respiratorju tal-Ħnieżer f'makrofaġi alveolari b'mod li jiddependi mid-doża.
English: When pigs are offered drinking water containing 300 or 400 mg/litre (equivalent to 22.5-40 mg/kg bodyweight or 1.5-2 times the recommended concentration) commonly animals exhibit a reduced water intake.
Maltese: Meta l-ħnieżer jingħataw ilma tax-xorb li jkun fih 300 jew 400 mg/litru (ekwivalenti għal 22.540 mg/kg piż tal-ġisem jew darba u nofs u darbtejn (1.5-2) il-konċentrazzjoni rakkomandata) normalment l-annimali juru tnaqqis fit-teħid tal-ilma.
English: No symptoms of overdose have been seen in turkeys given drinking water containing levels of tilmicosin up to 375 mg/litre (equivalent to 50-135 mg/kg bodyweight or 5 times the recommended dose) for 3 days; daily treatment with 75 mg/litre (equivalent to the maximum recommended dose) for 6 days also produced no symptoms of overdose.
Maltese: Ma deher l-ebda sintomu ta' doża eċċessiva fid-dundjani li ngħataw ilma tax-xorb li kien fih livelli ta' tilmikosina sa 375 mg/litru (ekwivalenti għal 50-135 mg/kg piż tal-ġisem jew 5 darbiet id-doża rakkomandata) għal 3 ijiem; kura ta' kuljum b'75 mg/litru (ekwivalenti għad-doża massima rakkomandata) għal 6 ijiem ukoll ma pproduċiet l-ebda sintomu ta' doża eċċessiva.
English: Oral solution Tilmicosin 250 mg/ml
Maltese: Tilmikosina (tilmicosin, bħala fosfat) 250 mg/ml.
English: Shelf life
Maltese: TAGĦRIF
English: In the event of accidental skin contact, wash thoroughly with soap and water.
Maltese: kuntatt aċċidentali mal-ġilda, aħsel sew bl-ilma u bis-sapun.
English: Pigs - 14 days Chickens - 12 days Turkeys - 19 days Calves - 42 days
Maltese: Ħnieżer - 14-il jum Tiġieġ - 12-il jum Dundjani - 19-il jum Għoġiela - 42 jum
English: Pigs
Maltese: Frat
English: Basingstoke
Maltese: Ċipru
English: Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
Maltese: Mycoplasma hyopneumoniae, Pasteurella multocida u Actinobacillus pleuropneumoniae.
English: Turkeys: For the treatment and prevention of respiratory disease in turkey flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Maltese: ¾ Tiġieġ u dundjani: Mycoplasma gallisepticum u Mycoplasma synoviae.
English: ¾ Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida and Actinobacillus pleuropneumoniae ¾ Chickens and turkeys: Mycoplasma gallisepticum and Mycoplasma synoviae ¾ Calves: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and M. dispar.
Maltese: Il-makrolidi, bħat-tilmikosina, jistgħu wkoll jikkawżaw ipersensittività (allerġija) wara t-titqib, l-inalazzjoni, l-inġestjoni jew il-kuntatt mal-ġilda jew l għajnejn.
English: Kölblgasse 8-10
Maltese: Pa[na 6 minn 20
English: 78 hours after the start of treatment, the tilmicosin concentration in lung tissue was 42.7 µg/g.
Maltese: 78 siegħa wara l-bidu tal-kura, il-konċentrazzjoni ta' tilmikosina fit-tessut tal pulmun kienet ta' 42.7 µg/g.
English: Withdrawal periods
Maltese: Perijodi ta' rtirar
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Polyethylene naphthalate amber coloured bottle with a polypropylene screw top and polyethylene/aluminium/polyethylene terephthalate seal.
Maltese: DETTALJI LI GĦANDHOM JIDHRU FUQ L-IPPAKKJAR EWLIENI Flixkun kulur l-ambra tal-polietilene naftalat b'tapp bil-kamin tal-polipropilene u siġill talpolietilene/aluminju/polietilene tereftalat.
English: Chickens Pigs
Maltese: Ħnieżer
English: - Propyl galate and disodium edentate should be included in Quantitative and Quantitative composition; - The Phamaceutical Form should be: Concentrate for Oral Solution for use in drinking water or milk replacer'; - Contraindications: include a new statement in relation to the hypersensitivity to tilmicosin; - Modified the special precautions to be taken by the person administering the veterinary medicinal product to animals; - The follow statements should be included: Not authorised for use in laying birds producing eggs for human consumption.
Maltese: Konċentrat għal Soluzzjoni Orali għall-użu fl-ilma tax-xorb jew fis-sostitut tal-ħalib'; - Kontra indikazzjonijiet għandha tinkludi dikjarazzjoni ġdida rigward is-sensittività eċċessiva għal tilmicosin; - Il-prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li sejra tagħti l-prodott mediċinali veterinarju lill-annimali għandhom jiġu emendati; - Għandhom jiġu inklużi d-dikjarazzjonijiet li ġejjin:
English: The CVMP accepts that a claim for efficacy at a dose of 10-27 mg/kg body weight for 3 days for the treatment and prevention of respiratory disease in turkey flocks, associated with Mycoplasma gallisepticum and M. synoviae, has been demonstrated.
Maltese: Is-CVMP jaċċetta li l-affermazzjoni għall-effikaċja f'doża ta' 10-27 mg/kg piż tal-ġisem għal 3 ijiem għall-kura u l-prevenzjoni ta' mard respiratorju fil-qatgħat tad-dundjani, assoċjat ma' Mycoplasma gallisepticum u M. synoviae, intweriet.
English: Pulmotil AC
Maltese: Pulmotil AC Soluzzjoni orali
English: 4.2 Indications for use, specifying the target species Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
Maltese: Għall-kura u l-prevenzjoni ta' mard respiratorju fil-merħliet tal-ħnieżer, assoċjat ma' Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae u organiżmi oħrajn suxxettibbli għal tilmikosina.
English: Turkeys
Maltese: TIKKETTA
English: The CVMP accepts that a claim for efficacy at a dose of 15-20 mg/kg bodyweight for 3 days for the treatment and prevention of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae has been demonstrated.
Maltese: Is-CVMP jaċċetta li l-affermazzjoni għall-effikaċja f'doża ta' 15-20 mg/kg piż tal-ġisem għal 3 ijiem għall-kura u l-prevenzjoni ta' mard respiratorju fil-qatgħat tat-tiġieġ, assoċjat ma' Mycoplasma gallisepticum u M. synoviae intweriet.
English: Romania
Maltese: Ir-Rumanija
English: Not all pack sizes may be marketed.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: Calves: To be included in milk replacer only, at a dose of 12.5 mg/kg bodyweight and given twice daily for 3-5 consecutive days, which may be achieved by the inclusion of 1 ml of product every 20 kg bodyweight.
Maltese: Għoġiela: Għandu jkun inkluż fis-sostitut tal-ħalib biss, f'doża ta' 12.5 mg/kg piż tal-ġisem u jingħata darbtejn kuljum għal 3-5 ijiem wara xulxin, liema doża tista' tinkiseb bl-inklużjoni ta' 1 ml prodott kull 20 kg piż tal-ġisem.
English: Lilly France SA Départament Elanco Santé Animale
Maltese: Eli Lilly Italia Elanco Animal Health Via A.
English: EXPIRY DATE EXP
Maltese: Gallat tal-propil
English: Zentiva Italia S.r.l.
Maltese: Italia S.r.l.
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Maltese: U kabelovny 130 102 37 Prague 10
English: Classification of expected frequencies:
Maltese: Klassifika tal-frekwenzi mistennija:
English: leucopenia (leucocytes >2 G/L)
Maltese: lewkopenja (lewkoċiti >2 G/L)
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Maltese: L-effett fuq kontraċettivi orali (0.03 mg ethinylestradiol u 0.15 mg levonorgestrel)
English: Rare:
Maltese: Rari:
English: 3 years.
Maltese: 3 snin
English: Symptoms
Maltese: Sintomi
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Maltese: Ma ntwerietx differenza bejn leflunomide u sulphasalazine (studju MN301).
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France
Maltese: Sanofi Winthrop Industrie 56, route de Choisy au bac F-60205 Compiegne Cedex Franza
English: • active psoriatic arthritis.
Maltese: • artrite psorjatika attiva.
English: Crospovidone (E1202) Talc (E553b)
Maltese: Povidone (E1201) Crospovidone (E1202) Talc (E553b)
English: Respiratory reactions
Maltese: Reazzjonijiet respiratorji
English: Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Maltese: Kategorija farmakoterapewtika: sustanzi selettivi li jbaxxu l-immunità, kodiċi ATC: L04AA13.
English: CPK increased
Maltese: żieda fi CPK
English: hepatitis, jaundice/cholestasis
Maltese: epatite, suffejra/kolestażi
English: Effect on repaglinide (CYP2C8 substrate)
Maltese: Effett fuq repaglinide (substrat ta' CYP2C8)
English: Date of latest renewal: 08 January 2015
Maltese: Data tal-aħħar tiġdid: 08 Jannar 2015
English: There is no indication that these effects are of clinical relevance.
Maltese: M'hemm l-ebda indikazzjoni li dawn l-effetti għandhom rilevanza klinika.
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Komuni:
English: Leflunomide Zentiva contains lactose.
Maltese: Leflunomide Zentiva fih il lactose.
English: This metabolite is responsible for essentially all the in vivo activity of Leflunomide Zentiva.
Maltese: Dan il-prodott metaboliku huwa essenzjalment responsabbli għall-attivita kollha in vivo ta' Leflunomide Zentiva .
English: Psoriatic arthritis
Maltese: Artrite psorjatika
English: Yellow ferric oxide (E172)
Maltese: Macrogol 8000 Ferric oxide isfar (E172)
English: Zentiva France
Maltese: Italia Zentiva
English: Aluminium / Aluminium blister.
Maltese: Aluminju/fojl ta' l-aluminju.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: in-nekroliżi tossika tal-ġilda, is-sindrome ta' Stevens-Johnson, eritema multiforme
English: Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Maltese: Titanium dioxide (E171) Macrogol 8000
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
Maltese: • artrite attiva, tat-tip rewmatojde bħala “mediċina antirewmatika li timmodifika l-marda”
English: S.C. ZENTIVA S.A.
Maltese: ZENTIVA S.A.
English: Colestyramine 8 g is administered 3 times daily.
Maltese: Għandu jingħata 8 g colestyramine 3 darbiet kuljum.
English: The unbound fraction of A771726 is about 0.62%.
Maltese: Il-parti ta' A771726 mhux marbuta hija ta' madwar 0.62%.
English: Maize starch Povidone (E1201)
Maltese: Sustanżi oħra jinkludu: maize starch, povidone (E1201), crospovidone
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Maltese: L-effett fuq BCRP (Proteina ta' Reżistenza għal Kanċer fis-Sider) u/jew substrati ta' polypeptide B1 u B3 li jittrasportaw l-anjoni organiċi (OATP1B1/B3)
English: Packs of 30, 50 and 100 tablets are available.
Maltese: Pakketti ta' 30, 50 u 100 pilloli huma disponibbli.
English: Infections
Maltese: Infezzjonijiet
English: Very rare:
Maltese: Rari ħafna:
English: severe infections, including sepsis which may be fatal
Maltese: Rari: infezzjonijiet severi, inkluż sepsis li tista' tkun fatali
English: Fertility was not reduced.
Maltese: Il-fertilità ma tnaqqsitx.
English: A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Maltese: A771726, li huwa il-prodott metaboliku attiv ta' leflunomide, jinibixxi l-enżima dihydroorotate dehydrogenase (DHODH) fil-bniedem, u juri attività anti-proliferattiva.
English: Peripheral neuropathy
Maltese: Newropatija periferika
English: • Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: It contains the active substance leflunomide.
Maltese: Fih is-sustanza attiva leflunomide.
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: 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 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.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Maltese: livelli għoljin tal-parametri tal-fwied (l-enżimi transaminases [speċjalment ALT], anqas spiss gamma-GT, alkaline phosphatase, bilirubin
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Maltese: Studji ta' inibizzjoni in vitro f'mikrosomi umani tal-fwied jissuġġerixxu li ċ-ċitokromi P450 (CYP) 1A2, 2C19 u 3A4 huma involuti fil-metaboliżmu ta' leflunomide.
English: anorexia, weight loss (usually insignificant), asthenia
Maltese: anoreksja, telf fil-piż (normalment mhux sinifikanti), astenja
English: Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Maltese: Każijiet rari ta' Multifocal Leukoencephalopathy Progressiva (PML) kienu rrapportati f'pazjenti li jirċievu l-kura b'leflunomide fost immunosoppressivi oħra.
English: pancreatitis
Maltese: pankrejatite
English: Immune system disorders Common:
Maltese: Disturbi fis-sistema immuni Komuni:
English: In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.
Maltese: F'pazjenti b'artrite tat-tip rewmatojde, ma kienx hemm interazzjoni farmakokinetika bejn leflunomide (10 sa 20 mg kuljum) u methotrexate (10 sa 25 mg fil-ġimgħa).
English: Cholestyramine or activated charcoal
Maltese: Cholestyramine jew charcoal attivat
English: EU/1/09/604/010 3 tablets
Maltese: EU/1/09/604/010 3 pilloli
English: • Patients with serious infections (see section 4.4).
Maltese: • Pazjenti b'infezzjonijiet severi, (ara sezzjoni 4.4).
English: EXP
Maltese: ZBP
English: Tél: +33 (0) 800 089 219 PV-France@zentiva.com
Maltese: Zentiva France Tél: +33 (0) 800 089 219 PV-France@zentiva.com
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 fit tnaqqis 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: The principal faecal component was A771726.
Maltese: Il-komponent prinċipali fl-ippurgar kien A771726.
English: Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Maltese: Leflunomide huwa metaboliżżat għal sustanza waħda ewlenija (A771726) u ħafna oħrajn minuri inkluż TFMA (4-trifluoromethylaniline).