FrancophonIA/ELRC3.0 huggingface dataset:
English: Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors e
Maltese: Valur-p għar-Rata ta' Rispons (CR+PR) mit-test chi-square Cochran Mantel-Haenszel aġġustat għal fatturi ta' stratifikazzjoni e
English: Do not give by other routes.
Maltese: ISS u lgħadd ta' linji ta' qabel.
English: 1.3 The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
Maltese: 1.3 L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita ġiet murija f'konċentrazzjonijiet ta' 1 mg/ml u 2.5 mg/ml għal 96 siegħa f'temperatura ta' 25°C, meta miżmum fil-kunjett oriġinali u/jew siringa għal 8 ijiem f'temperatura ta' 2-8°C.
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Maltese: Newropatiji*, Newropatija motorja*, Telf ta' koxjenza (inkluż sinkope), Enċefalopatija*, Newropatija sensomotorja periferali, Sturdament*, Disgewżja*, Newropatija awtonomika
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Maltese: Grad 4 (konsegwenzi li jistgħu jkunu ta' li thedida għal l-ħajja; intervent urġenti indikat) u/jew newropatija awtonomika
English: Nervous system disorders Very common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Komuni ħafna Newropatija tas-sensazzjoni periferali, Disastesija*, Nevralġija* Komuni
English: 9/l on a bortezomib dosing day (other than day 1)
Maltese: Esponiment għal bortezomib (AUC u C
English: Adverse reaction Infections and infestations Very common Pneumonia* Common
Maltese: Komuni ħafna Pulmonite* Komuni
English: Table 4: Posology for bortezomib combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Maltese: Tabella 4: Pożoloġija għal terapija kombinata bi bortezomib għal pazjenti b'majeloma multipla li ma kienux ġew ittrattati qabel eliġibbli għal trapjant b'ċelluli steminali ematopojetiċi
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia (inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Maltese: Mewt (anke f'daqqa), Falliment ta' diversi organi, Emorraġija fis-sit tal-injezzjoni*, Ftuq*, Flebite fis-sit tal-injezzjoni*, Fejqan indebolit, Infjammazzjoni*, Flebite fis-sit ta' injezzjoni, Tenerezza, Ulċera, Irritabilità, Uġigħ tas-sider mhux tal-qalb, Uġigħ fis-sit tal-katiter, Sensazzjoni ta' korp barrani
English: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni għal injezzjoni ġol-vina fih 2.5 mg bortezomib
English: Adverse reaction
Maltese: kontrazzjonijiet
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Kull kunjett ta' 10 ml ta' bortezomib irid ikun rikostitwit b'attenzjoni bi 3.5 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: > 1 prior line of therapy
Maltese: >linja waħda ta' terapija fil-passat
English: Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Maltese: Sepsi (inkluż xokk settiku)*, Herpes zoster (inkluż mifrux u talgħajn), Infezzjoni bil-virus tal-herpes*, Infezzjonijiet bilbatterji*, Infezzjoni fil-passaġġ tan-naħa ta' fuq/ta' taħt tannifs*, Infezzjoni bil-fungu*, Herpes simplex* Mhux komuni Epatite B, Infezzjoni*, Bronkopnewmonja
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Maltese: Mhux komuni Disturb mentali*, Alluċinazzjoni*, Disturb psikotiku*, Konfużjoni*, Irrikwitezza
English: If you have not been treated before for mantle cell lymphoma you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: BR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, u prednisone;
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
Maltese: Terapija bi bortezomib għandha titwaqqaf meta l-għadd ta' plejtlits ikun < 25,000/l jew, fil-każ ta' għoti flimkien ma' melphalan u prednisone, meta l-għadd tal-plejtlits ikun ta' ≤ 30,000/l (ara sezzjoni 4.2).
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Maltese: Id-Dosing Slide Rule għandu jkun fiha l-elementi ewlenin li ġejjin:
English: Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Maltese: Bortezomib flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għattrattament ta' pazjenti adulti b'limfoma taċ-ċellula mantle li qatt ma kienet ittrattata qabel li mhumiex addattati għal trapjant taċ-ċellula steminali ematopojetika.
English: Bortezomib treatment must be withheld at the onset of any ≥ grade 3 bortezomib -related non-haematological toxicities (excluding neuropathy) or ≥ grade 3 haematological toxicities (see also section 4.4).
Maltese: It-trattament bi bortezomib għandu jitwaqqaf mal-bidu ta' kwalunkwe tossiċitajiet mhux ematoloġiċi (minbarra newropatija) ta' ≥ grad 3 marbuta ma' bortezomib jew tossiċitajiet ematoloġiċi ta' ≥ Grad 3 (ara wkoll sezzjoni 4.4).
English: Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Maltese: It-trattament bi bortezomib ħafna drabi jiġi assoċjat ma' newropatija periferali, l-iktar dik sensorjali.
English: Uncommon Pancytopenia*
Maltese: Abnormalità fil-enzimi tal-fwied*
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Maltese: Bortezomib Fresenius Kabi 3.5 mg trab għal soluzzjoni għall-injezzjoni huwa għal użu ġol-vina u għal taħt il-ġilda.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Maltese: Dexamethasome kien mogħti f'kombinazzjoni ma' bortezomib lil 83 pazjent f'Ċiklu 1 bi 11-il pazjenti addizzjonali jirċievu dexamethasome waqt il-kors ta' ċiklu ta' trattament bi bortezomib.
English: 1 prior line of therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • Mouth ulcers
Maltese: • Ulċeri fl-imsaren
English: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Maltese: Reazzjonijiet avversi serji rrappurtati b'mod mhux komuni waqt trattament bi bortezomib jinkludu insuffiċjenza tal-qalb, sindromu ta' lisi tat-tumur, pressjoni għolja fil-pulmun, sindromu ta' enċefalopatija riversibbli fuq in-naħa ta' wara, disturbi pulmonari akuti diffużi u infiltrattivi, u b'mod rari newropatija awtonomika.
English: Gastrointestinal disorders Very common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Maltese: Komuni ħafna Sintomi ta' nawsja u rimettar*, Dijarea*, Stomatite*, Stitikezza Komuni
English: Pegylated liposomal doxorubicin is administered at 30 mg/m on day 4 of the bortezomib treatment cycle as a 1 hour intravenous infusion administered after the bortezomib injection.
Maltese: Pegylated liposomal doxorubicin jiġi amministrat f'30 mg/m fil-Jum 4 taċ-ċiklu ta' trattament ta'
English: In cycles 1-4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Maltese: Fiċ-ċikli 1-4, bortezomib jingħata darbtejn fil- ġimgħa fil-jiem 1, 4, 8, 11, 22, 25, 29 u 32. Fiċ-ċikli 5-9, bortezomib jingħata darba filġimgħa fil- jiem 1, 8, 22 u 29.
English: Mannitol (E 421)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Mannitol (E 421)
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Maltese: Fi studji f'pazjenti b'majeloma multipla li rkadiet li ġiet ittrattata bi bortezomib u f'pazjenti b'MCL li qatt ma kienet ittrattata qabel li ġiet ittrattata bi bortezomib flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (BR-CAP), waħda mill-iktar tossiċitajiet ematoloġiċi komuni kienet tromboċitopenija temporanja.
English: - If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from
Maltese: • Jekk it-tossiċità tgħaddi i.e. il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL, bortezomib jista' jerġa' jinbeda mill-ġdid bid-doża mnaqqsa b'livell wieħed ta' doża (minn 1.3 mg/m għal 1 mg/m 2, jew minn
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Maltese: Fi prova klinika, żewġ pazjenti (minn 2) li ngħataw doża qawwija ta' cytarabine (2 g/m kuljum) b'infużjoni kontinwa matul 24 siegħa b'daunorubicin u bortezomib għal episodju ġdid ta' lewkimja akuta majloġenuża mietu minħabba ARDS fil-bidu tat-terapija, u l-istudju twaqqaf.
English: 9/l or ANC
Maltese: 9/l
English: Combination therapy with dexamethasone and thalidomide
Maltese: Kombinazzjoni ma' dexamethasone
English: Very common Hair disorder* Common
Maltese: Komuni ħafna Disturb fix-xagħar* Komuni
English: #, Stevens-Johnson syndrome Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Maltese: Disturb fix-xagħar*, Petekije, Eċċimosi, Ġerħa fuq il-ġilda, Purpura, Għoqda fil-ġilda*, Psorijasi, Iperidrosi, Għorieq bil-lejl, Ulċera dekubitè
English: or ANC < 750 cells/μL on a bortezomib dosing day (other than Day 1 of each cycle)
Maltese: jew l-ANC ikun < 750 ċellula/μL f'ġurnata ta' għoti ta' doża ta' bortezomib (ħlief fil-Jum 1 ta' kull ċiklu)
English: Combination therapy with melphalan and prednisone Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in table 2.
Maltese: Terapja ta' kombinazzjoni b'melphalan u prednisolone Bortezomib Fresenius Kabi 3.5 mg trab għal soluzzjoni għall-injezzjoni jingħata bħala injezzjoni ġolvina jew taħt il- ġilda flimkien ma' melphalan mill-ħalq u prednisone mill-ħalq kif muri f'Tabella 2.
English: In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Maltese: Fi studji ta' tossiċità ġenerali ta' iktar minn ċiklu wieħed, li saru fuq il-firien u x-xadini, l-organi li ntlaqtu prinċipalment kienu l-passaġġ gastrointestinali, li wassal għal rimettar u/jew dijarea: tessuti ematopojetiċi u limfatiċi, li wassal għal ċitopeniji fid-demm periferali, atrofija tat-tessuti limfojdi u ipoċellularità ematopojetika tal-mudullun; newropatija periferali (osservata f'xadini, ġrieden u klieb) li tinkludi l-axons tan-nervituri sensorjali; u bidliet ħfief fil-kliewi.
English: Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Maltese: Tabella 11: Riżultati dwar l-effikaċja wara l-aġġornament finali ta' sopravivenza fl-istudju VISTA
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Maltese: Abbażi tat-test Log rank stratifikat bir-riskju IPI u l-istadju tal-marda.
English: In addition, the incidence of grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Maltese: Barra minn hekk, l-inċidenza ta' newropatiji periferali ta' grupp 3 jew ogħla kien 10 % inqas, u r-rata ta' waqfien minħabba newropatiji periferali kien ta' 8 % inqas għall-grupp ta' taħt il-ġilda meta mqabbel mal-grupp ġol-vina.
English: Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis
Maltese: Mhux komuni Eritema multiforme, Urtikarja, Dermatosi newtrofilika akuta bid-deni, Infafet tossiċi fuq il-ġilda, Nekrosi epidermali tossika #, Sindromu ta' Stevens-Johnson
English: Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion Blepharitis
Maltese: Mhux komuni Disakusi (li jinkludi tinnite)*, Is-smigħ imxekkel (sa anke truxija), Dwejjaq fil-widnejn*
English: Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS
Maltese: Emorraġija fil-widnejn, Newronite vestibulari, Disturb filwidnejn NOS
English: a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c
Maltese: 222 individwu ġew arwolati fl-istudju; 221 individwu kienu trattati bi bortezomib c
English: • Brittle or weak nails
Maltese: • Diffikultà jew problemi bl-irqad
English: Hypotension
Maltese: Ipotajrojdiżmu
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m
Maltese: Tal-anqas 6 xhur wara t-terapija ta' qabel, bortezomib inbeda fl-aħħar doża ttolerata ta' 1.3 mg/m
English: Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
Maltese: Mhux komuni Deterjorament ġenerali tas-saħħa fiżika*, Edema tal-wiċċ*, Reazzjoni fis-sit tal-injezzjoni*, Disturb mukosali*, Uġigħ fis-sider, Disturb fil-pass, Tħoss il-ksieħ, Ekstravażazzjoni*, Komplikazzjoni marbuta mal-katiter*, Bidla fl-għatx*, Dwejjaq fis-sider, Tħoss bidla fit-temperatura tal-ġisem*, Uġigħ fis-sit tal-injezzjoni*
English: EU/2/99/017/001 Bovalto Ibraxion gE deleted inactivated IBR virus, at least 0.75
Maltese: EU/2/99/017/001 Bovalto Ibraxion il-vajrus inattivat
English: EU (MA) number Invented name
Maltese: Numru tal-UE (MA)
English: Packaging Content Package Size
Maltese: Kontenut Daqs talpakkett
English: * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Maltese: * VN.U: titlu tal-antikorp li jinnewtralizza il-vajrus wara t-tlaqqim tal-vaċċin fil-fniek ta' l-Indi.
English: Cattle
Maltese: Qawwa
English: Target Species Route of administration
Maltese: Mod ta' Amministrazzjoni
English: Pharmaceutical Form
Maltese: Għamla Farmaċe wtika
English: Emulsion for injection
Maltese: Emulsjoni għallinjezzjoni il-vajrus inattivat
English: NSAIDs/Corticosteroids
Maltese: NSAIDS/Kortikosterojdi
English: Crospovidone type A Pregelatinized starch (maize) Talc
Maltese: Crospovidone tip A Pregelatinized starch (qamħirrun) Talc
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007
Maltese: ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007
English: Warfarin and other coumarine anticoagulants
Maltese: Warfarin u antikoagulanti coumarine oħra
English: Portugal Teva Pharma - Produtos Farmacêuticos Lda
Maltese: Teva Pharma - Produtos Farmacêuticos Lda Tel:
English: Repso contains lactose.
Maltese: Repso fih lactose.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG Ir-Renju Unit
English: - The active substance is leflunomide.
Maltese: Is-sustanza attiva hi leflunomide.
English: hypokalaemia, hyperlipidemia, hypophosphataemia
Maltese: Mhux komuni ipokalemija, iperlipidemija, ipofosfatemija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Marzu 2011
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoloskeletriċi u tat-tessut konnettiv
English: - Loss of appetite.
Maltese: - Nuqqas t'aptit.
English: • active psoriatic arthritis.
Maltese: • b'artrite psorijatika attiva
English: This metabolite is responsible for essentially all the in vivo activity of leflunomide.
Maltese: Dan il-metabolit huwa essenzjalment responsabbli għallattività kollha in vivo ta' leflunomide.
English: (leucopenia).
Maltese: (suffejra).
English: - Colitis.
Maltese: - Kolite.
English: CYP450 inhibitors and inducers
Maltese: Inibituri u indutturi ta' CYP450
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
Maltese: • b'artrite rewmatojdi bħala "mediċina antirewmatika li timmodifika l-marda" (DMARD).
English: Other medicines and Repso
Maltese: Mediċini oħra u Repso
English: Effect on organic anion transporter 3 (OAT3) substrates
Maltese: L-effett fuq substrati tat-trasportatur tal-anjoni organiċi 3 (OAT3)
English: Each film-coated tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose.
Maltese: Kull pillola miksija b'rita fiha 97.25 mg ta' lactose monohydrate u 3.125 mg lactose anidru.
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: • Sensittività eċċessiva (speċjalment sindromu preċedenti ta' Stevens-Johnson, nekrosi tossika epidermali, eritema multiforme) għas-sustanza attiva, għall-metabolit attiv prinċipali teriflunomide jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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: 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-ċitokromu P450 (CYP) 1A2, 2C19 u 3A4 huma involuti fil-metaboliżmu ta' leflunomide.
English: Effect on caffeine (CYP1A2 substrate)
Maltese: Effett fuq il-kaffeina (substrat ta' CYP1A2)
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 tal-ACR (American College of Rheumatology) fl-istudju YU203 kienu 27.7 % għal plaċebo, 31.9 % għal 5 mg, 50.5 % għal 10 mg u 54.5 % għal 25 mg/jum.
English: Psoriatic arthritis is the combination of psoriasis and arthritis.
Maltese: L-artrite psorijatika hija l-kombinazzjoni ta' psorijasi u artrite.
English: Quinoline Yellow Aluminium lake (E104) Indigo Carmine Aluminium Lake (E132)
Maltese: Quinoline Yellow Aluminium lake (E104)
English: Frequency groupings are defined according to the following convention: 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: Il-gruppi tal-frekwenza huma definiti skont il-konvenzjoni li ġejja: 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: 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 ta' ACR fil-pazjenti fuq leflunomide kienu 52.3 % (studji MN301/303), 50.5 % (studju MN302) u 49.4 % (studju US301), meta mqabbla ma' 53.8 % (studji MN301/303) f'pazjenti fuq sulphasalazine, 64.8 % (studju MN302), u 43.9 % (studju US301) f'pazjenti fuq methotrexate.
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, jimpedixxi l-enżima dihydroorotate dehydrogenase (DHODH) fil-bniedem, u juri attività antiproliferattiva
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 30 tablets 100 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT Pillola miksija b'rita 30 pillola 100 pillola METODU U MOD(I) TA' AMMINISTRAZZJONI Użu orali.
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Maltese: livelli ogħla fil-parametri tal-fwied (transaminases [speċjalment ALT], inqas komuni gamma-GT, alkaline phosphatase, bilirubin)
English: Effect on warfarin (CYP2C9 substrate)
Maltese: L-effett fuq warfarin (substrat ta' CYP2C9)
English: Each film-coated tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose.
Maltese: Kull pillola miksija b'rita fiha 194.5 mg ta' lactose monohydrate u 6.25 mg lactose anidru.
English: Silica, colloidal anhydrous Lactose anhydrous Magnesium stearate
Maltese: (qamħirrun), talc, anhydrous colloidal silica, lactose anidru u magnesium stearate.
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 drabi, 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: • Tablet coating: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake and indigo carmine aluminium lake.
Maltese: • Il-kisi tal-pillola: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate,