FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom Sandoz Limited, Frimley Business Park, Frimley,
Maltese: Ir-Renju Unit Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Maltese: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: Jennifer 35 2 mg/0,035 mg Filmtabletten
Maltese: Jennifer 35 2 mg/0,035 mg Filmtabletten 0,035 mg 2,00 mg
English: Almirall Hermal GmbH Scholzstr.
Maltese: Il-Ġermanja Taurus Pharma GmbH Benzstr.
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Maltese: Pharmaceuticals Limited Kramer Mews London SW5
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Maltese: 49 avenue Georges Pompidou
English: RANBAXY PHARMACIE GENERIQUES
Maltese: Qawwa Għamla Farmaċewtika
English: Germany acis Arzneimittel GmbH Lil-Dagover-ring 7
Maltese: Il-Ġermanja Dermapharm AG Lil-Dagover-Ring 7
English: BN22 9AG
Maltese: East Sussex BN22 9AG United Kingdom
English: Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
Maltese: 2 Grigori Afxentiou Street
English: Cyproderm
Maltese: CYPROPHARM
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Maltese: Via Ponte della Fabbrica 3/A
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Maltese: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Maltese: L-Olanda ratiopharm Nederland B.V.
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Maltese: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Maltese: Diane-35 0,035mg/2mg überzogene Tablette
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Maltese: DK-4230 Skælskør Denmark
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Maltese: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Maltese: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Maltese: Ranbaxy Pharmacie Generiques 11-15 quai de Dion Bouton
English: CYPROTERONE/ETHIN YLESTRADIOL DCI PHARMA 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Maltese: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: FARMALIDER, S.A.
Maltese: Generis Farmaceutica, S.A.
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Maltese: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: CYPROTERONE/ETHIN YLESTRADIOL SANDOZ 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Maltese: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: Diane 0,035 mg/2 mg obložene tablete
Maltese: Diane 0,035 mg/2 mg obložene tablete 0,035 mg 2,00 mg
English: Camilette CoCyprindiol 2000/35 Tablets
Maltese: Camilette Co-Cyprindiol 2000/35
English: CYPROTERONE/ETHIN YLESTRADIOL ZENTIVA 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg
English: London SW5 9JL
Maltese: 9JL United Kingdom
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Maltese: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL TEVA 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZYDUS 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg
English: Aragoneses, 15
Maltese: Piłsudskiego 5
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Maltese: Orifarm Generics A/S Postbox 69
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Maltese: Anness I Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq flIstati Membri
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Maltese: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: CYPROTERONE/ETHIN YLESTRADIOL EG 2 mg/0,035 mg
Maltese: CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg
English: Portugal
Maltese: Lisboa Portugal
English: ETINILESTRADIOL/CIP ROTERONA
Maltese: CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM
English: Strandhaven CoCyprindiol 2000/35 Tablets
Maltese: Strandhaven Co-Cyprindiol 2000/35
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Maltese: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: Co-Cyprindiol Tablets
Maltese: Film-coated tablet
English: Station Close
Maltese: High Road
English: STRAGEN
Maltese: Esher
English: Norway
Maltese: Eastbourne
English: Bayer Pharma AG D-13342 Berlin Germany
Maltese: D-13342 Berlin Germany
English: Generics (UK) Limited trading as Mylan
Maltese: Ir-Renju Unit Generics (UK) Limited Station Close
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Maltese: Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: Arimidex 1mg filmsko obložene tablete
Maltese: Arimidex 1 mg film coated tablets
English: Etterstad 0601, OSLO
Maltese: Etterstad 0601 OSLO, Norway
English: Rua Humberto Madeira, n.º 7, Queluz de Baixo, 2730-097 Barcarena, Portugal
Maltese: Rua Humberto Madeira, No. 7, Queluz de Baixo, 2730-097 Barcarena, Portugal
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire
Maltese: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire
English: AstraZeneca Kft. 1113 Budapest, Bocskai ut 134
Maltese: 1113 Budapest, Bocskai ut 134-146 Hungary
English: 1, Place Renault 92844 RUEIL-MALMAISON CEDEX
Maltese: Rueil-Malmaison CEDEX
English: AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens,
Maltese: Theotokopoulou & Astronafton str 151 25
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium
Maltese: B-1180 Brussell, Belgium
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund, Denmark
Maltese: 2620 Albertslund, Denmark
English: AstraZeneca UK Ltd. 2 Kingdom Street, London
Maltese: AstraZeneca UK Ltd 2 Kingdom Street London W2 6BD United Kingdom
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien,
Maltese: AstraZeneca Ősterreich GmbH Schwarzenbergplatz 7
English: S-15185 Södertälje, Sweden
Maltese: S-15185
English: AstraZeneca GmbH Tinsdaler Weg 183
Maltese: AstraZeneca GmbH 22880
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT, ID-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: AstraZeneca UK Limited 2 Kingdom Street, London
Maltese: AstraZeneca UK Limited, 2 Kingdom Street London W2 6BD United Kingdom
English: Slovak Republic
Maltese: Is-Slovakja
English: AstraZeneca Farmacéutica Spain, S.A.
Maltese: AstraZeneca S.A.
English: Luton
Maltese: Wedel
English: C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid, Spain
Maltese: 28033 Madrid, Spain
English: • urticaria (nettle rash),
Maltese: • urtikarja (nettle rash),
English: Date of latest renewal: 23 March 2015
Maltese: Data tal-aħħar tiġdid: 23 ta' Marzu 2015
English: • tizanidine, a muscle relaxant
Maltese: • tizanidine, rilassant tal-muskoli
English: leucopenia (leucocytes > 2 G/l)
Maltese: lewkopenja (lewkoċiti > 2 G/l)
English: • cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
Maltese: • cefaclor, benzylpenicillin (penicillin G), ciprofloxacin għall-infezzjonijiet
English: Tablet core: lactose monohydrate low-substituted hydroxypropyl cellulose tartaric acid sodium laurylsulfate magnesium stearate
Maltese: Il-qalba tal-pillola: lactose monohydrate low-substituted hydroxypropyl cellulose tartaric acid sodium laurylsulfate magnesium stearate
English: Film-coating: lecithin (soybeans) poly(vinyl alcohol) talc titanium dioxide (E 171) xanthan gum
Maltese: Ir-rita tal-pillola: lecithin (soybeans) poly(vinyl alcohol) talc titanium dioxide (E 171) xanthan gum
English: Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster
Maltese: Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster Il-Ġerman ja medac
English: • rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
Maltese: • rosuvastatin, simvastatin, atorvastatin, pravastatin għall-iperkolesterolimja (kolesterol għoli)
English: • colitis,
Maltese: • kolite,
English: (see section 4.2).
Maltese: (ara wkoll sezzjoni 4.6).
English: • teriflunomide for multiple sclerosis
Maltese: • teriflunomide għas-sklerożi multipla
English: (pancytopenia),
Maltese: (tromboċitopenja),
English: • daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
Maltese: • daunorubicin, doxorubicin, paclitaxel, jew topotecan għal kanċer
English: • oral contraceptives (containing ethinylestradiol and levonorgestrel)
Maltese: • kontraċettivi orali (li fihom ethinylestradiol u levonorgestrel)
English: Williams & Halls ehf.
Maltese: Halls ehf.
English: • inflammation of the pancreas (pancreatitis),
Maltese: • infjammazzjoni tal-frixa (pankreatite),
English: There is no indication that these effects are of clinical relevance.
Maltese: M'hemm lebda indikazzjoni li dawn l-effetti għandhom rilevanza klinika.
English: Gidamed Medical Supplies Ltd. Τηλ:+ 357-257 510 30
Maltese: Τηλ: +357-257 510 30
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Maltese: panċitopenja (probabilment minn mekkaniżmu anti-proliferattiv), lewkopenja (lewkoċiti < 2 G/l), esinofilja
English: • diarrhoea,
Maltese: • dijarrea,
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.>
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: Ελλάδα medac GmbH
Maltese: Slovenija medac GmbH
English: • The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E 171) and xanthan gum in the film-coating.
Maltese: • Is-sustanżi l-oħra huma lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate u magnesium stearate fil-qalba tal-pillola kif ukoll lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E 171) u xanthan gum fir-rita tal-pillola.
English: C study indicated that at least about 82 to 95 % of the dose is absorbed.
Maltese: C uriet li mhux inqas minn 82 sa 95 % tad-doża kienet assorbita.
English: • theophylline for asthma
Maltese: • theophylline għall-ażma
English: The unbound fraction of A771726 is about 0.62 %.
Maltese: Il-parti ta' A771726 mhux marbuta hija ta' madwar 0.62 %.
English: • repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
Maltese: • repaglinide, pioglitazone, nateglinide, jew rosiglitazone għad-dijabete
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: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide medac.
Maltese: Dan il-prodott metaboliku huwa essenzjalment responsabbli għall-attivita kollha in vivo ta' Leflunomide medac.
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 A771726.
Maltese: Kien hemm żieda fil-medja tas-Cmax u l-AUC0-24 (1.58 u 1.54 darbiet, rispettivament) ta' ethinylestradiol, u fis-Cmax u l-AUC0-24 (1.33 u 1.41 darbiet, rispettivament) ta' levonorgestrel, wara l-għoti ta' dożi ripetuti ta' A771726.
English: • The active substance is leflunomide.
Maltese: • Is-sustanza attiva hija leflunomide.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Komuni:
English: • Patients with serious infections (see section 4.4).
Maltese: • Pazjenti b'infezzjonijiet severi, (ara sezzjoni 4.4)
English: After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3 % (studies MN301/303), 50.5 % (study MN302) and 49.4 % (study US301), compared to 53.8 % (studies MN301/303) in sulphasalazine patients, 64.8 % (study MN302), and 43.9 % (study US301) in methotrexate patients.
Maltese: Wara 12-il xahar ta' kura attiva, ir-rati ta' rispons skond l-ACR fil-pazjenti fuq leflunomide kienu 52.3 % (studji MN301/303), 50.5 % (studju MN302) u 49.4 % (studju US301), ikkomparati ma' 53.8 % (studji MN301/303) tal-pazjenti fuq sulphasalzine, 64.8 % (studju MN302), u 43.9 % (studju US301) tal-pazjenti fuq methotrexate.
English: • 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: INFORMATION IN BRAILLE Leflunomide medac 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Leflunomide medac 10 mg
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: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatise, bilirubin).
Maltese: Ir-reazzjonijiet avversi l-aktar irrapportati bi leflunomide huma: żieda ħafifa fil-pressjoni tad-demm, lewkopenja, parasteżija, uġigħ ta' ras, sturdament, dijarrea, tqalligħ, rimettar, disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali, twaqqigħ tax-xagħar aktar minn normal, ekżema, raxx (jinkludi raxx ikkaratteriżżat minn titbigħ u ponot), ħakk, ġilda xotta, tenosynovitis, żieda fi CPK, anoreksja, telf fil-piż (normalment mhux sinifikanti), astenja, reazzjonijiet allerġiċi ħfief u livelli għoljin tal-parametri tal-fwied (l-enżimi transaminases [speċjalment ALT], anqas spiss gamma-GT, alkaline phosphatase, bilirubin).
English: • For psoriatic arthritis: 20 mg Leflunomide medac once daily.
Maltese: • Għall-artrite psorjatika: 20 mg Leflunomide medac darba 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: Leflunomide medac contains lactose.
Maltese: Leflunomide medac fih il lactose.
English: • severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Maltese: • reazzjonijiet severi, x'imdaqqiet fatali (is-sindrome ta' Stevens-Johnson, in-nekrosi tossika u esfoljattiva tal-ġilda, eritema multiforme).
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).
Maltese: III, ir-rati ta' rispons skond l-ACR għal 20 mg leflunomide kuljum kontra il-plaċebo, kienu ta' 54.6 % kontra 28.6 % (studju MN301), u 49.4 % kontra 26.3 % (studju US301).
English: <Leflunomide medac 15 mg:> 30 film-coated tablets
Maltese: <Leflunomide medac 15 mg:> 30 pilloli miksija b'rita
English: Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 76 mg ta' lactose (bħala monohydrate) u 0.06 mg ta' soya lecithin.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, peanut or soya or to any of the excipients listed in section 6.1.
Maltese: • Sensitività eċċessiva (speċjalment jekk kellhom preċedentement is-sindromu Stevens-Johnson, in-nekrożi tossika u esfoljattiva tal-ġilda, l-eritema multiforme) għas-sustanza attiva, għallprodott metaboliku attiv prinċipali teriflunomide, jew sojja jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • anxiety,
Maltese: • ansjetà,
English: • inflammation of the lung (interstitial lung disease),
Maltese: • infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun),
English: • furosemide for heart disease (diuretic, water pill)
Maltese: • furosemide għall-mard tal-qalb (dijuretiku, pillola tal-ilma)
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: 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 < 0.0001).
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10 % to 50 %.
Maltese: A771726 jisposta lil ibuprofen, lil diclofenac u lil tolbutamide, iżda l-parti mhux marbuta ta' dawn il-mediċini tiżdied biss b'10% sa 50 %.
English: • eczema, dry skin, rash, itching,
Maltese: • ekżema, ġilda xotta, raxx, ħakk,
English: The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n = 102), leflunomide 5 mg (n = 95), 10 mg (n = 101) or 25 mg/day (n = 104).
Maltese: II, YU203, 402 pazjenti li kellhom l-artrite rewmatikaattiva kienu mqassmin, mingħajr għażla, f'erba' gruppi: dawk bil-plaċebo (n = 102) u dawk b'5 mg (n = 95), 10 mg (n = 101) jew 25 mg (n = 104) leflunomide kuljum.
English: Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 114 mg ta' lactose (bħala monohydrate) u 0.09 mg ta' soya lecithin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 July 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Lulju 2010
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal Not known: pulmonary hypertension
Maltese: disturbi ta' l-interstitium tal-pulmun (inkluża l-pulmonite interztizjali), li tista' tkun fatali
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37 % in 24 hours and by 48 % in 48 hours.
Maltese: Intwera li t-teħid ta' 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 talprodott metaboliku attiv, A771726, b' 37 % f'24 siegħa u b'48% f'48 siegħa.
English: Leflunomide medac contains soya lecithin.
Maltese: Leflunomide medac fih soya lecithin.
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Maltese: It-tagħrif farmakokinetiku fl-anzjani (> 65 sena) huwa limitat, iżda hija konsistenti mal-komportament farmakokinetiku f'pazjenti adulti ta' età iżgħar.
English: The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Maltese: L-effikaċja ta' leflunomide intwera fi studju wieħed 3L01, li kien ikkontrollat, randomized u double-blind u li sar fuq 188 pazjent bl-artrite psorjatika, ittrattati b'20 mg/jum.
English: In a small prospective study in women (n = 64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p = 0.13) were observed in the overall rate of major structural defects (5.4 %) compared to either of the comparison groups (4.2 % in the disease matched group [n = 108] and 4.2 % in healthy pregnant women [n = 78]).
Maltese: Fi studju prospettiv żgħir fin-nisa (n = 64)li saru involontarjament tqal waqt li kienu qegħdin jieħdu lleflunomide għal mhux aktar minn tliet ġimgħat wara l-konċepiment u segwit minn proċedura tattneħħija tad-droga, l-ebda differenzi (p = 0.13) ma kienu osservati fir-rata ġenerali tad-difetti strutturali kbar (5.4 %) meta mqabbel ma' wieħed jew l-ieħor mil-gruppi komparati (4.2 % tal-grupp mqabbel talmarda [n = 108] u 4.2 % f'nisa tqal b'saħħithom [n = 78]).
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: paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: parasteżija, uġigħ ta' ras, sturdament, newropatija periferika
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Lulju 2013
English: For other substrates of BCRP (e.g. methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Maltese: Għal substrati oħrajn ta' BCRP (eż., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) u l-familja ta' OATP, speċjalment l-inibituri ta' HMG-Co reductase (eż., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) l-għoti fl-istess ħin għandu wkoll isir b'kawtela.