FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal mediċini.
English: The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' teriflunomide fit-tfal minn età ta' 10 sa 18-il sena ma ġewx determinati s'issa.
English: A total of 1088 patients with RMS were randomised in TEMSO to receive 7 mg (n=366) or 14 mg (n=359) of teriflunomide or placebo (n= 363) for 108 weeks duration.
Maltese: Total ta' 1088 pazjent b'RMS intgħażlu b'mod każwali fl-istudju TEMSO biex jirċievu 7 mg (n=366) jew 14il mg (n=359) ta' teriflunomide jew plaċebo (n= 363) għal perjodu ta' 108 ġimgħat.
English: Sanofi AB Tel: +46 (0) 8 634 5000
Maltese: Tel: +46 (0) 8 634 5000
English: Teriflunomide was not mutagenic in vitro or clastogenic in vivo.
Maltese: Teriflunomide ma kienx mutaġeniku in vitro jew klastoġeniku in vivo.
English: Other medicines and AUBAGIO
Maltese: Mediċini oħra u AUBAGIO
English: Teriflunomide is the main metabolite of leflunomide.
Maltese: Teriflunomide hu l-metabolit ewlieni ta' leflunomide.
English: Effect of teriflunomide on oral contraceptives: 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel 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 teriflunomide.
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' teriflunomide.
English: 14 film-coated tablets 28 film-coated tablets 84 (3 wallets of 28) film-coated tablets 98 (7 wallets of 14) film-coated tablets 10x1 film-coated tablet
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 84 (3 portafolli ta' 28) pillola miksija b'rita 98 (7 portafolli ta' 14) pillola miksija b'rita 10x1 pillola miksija b'rita
English: After stopping treatment with teriflunomide:
Maltese: Wara li titwaqqaf il-kura b'teriflunomide:
English: Potential to prolong the QT interval
Maltese: Potenzjal li jittawwal l-intervall tal-QT
English: AUBAGIO is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters.
Maltese: AUBAGIO hu disponibbli f'kaxxi tal-kartun li fihom: - 14, 28, 84 u 98 pillola f'pakketti portafoll b'folji integrati tal-aluminju; - 10xpillola 1 f'folji imtaqqbin kollha kemm huma tal-aluminju, għal dożi waħdiet.
English: Clastogenicity observed in vitro was considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of DHO-DH inhibition.
Maltese: Il-klastoġeniċità osservata in vitro ġiet ikkunsidrata li hi effett indirett relatat ma' żbilanċ fin-nucleotide pool li jirriżulta mill-farmakoloġija tal inibizzjoni ta' DHO-D H.
English: Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
Maltese: Pilloli ta' lewn blu ċar sa blu pastell pentagonali miksija b'rita, stampati fuq naħa waħda (‘14') u mnaqqxa b'logo tal-korporazzjoni fuq in-naħa l-oħra.
English: In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo.
Maltese: 5% li kienu qed jirċievu plaċebo; - il-pressjoni sistolika tad-demm kienet >160 mm Hg f'3.8% tal-pazjenti li kienu qed jirċievu 14il mg/jum ta' teriflunomide meta mqabbla ma' 2.0% li kienu qed jirċievu plaċebo; - il-pressjoni dijastolika tad-demm kienet >90 mm Hg f21.4% tal-pazjenti li kienu qed jirċievu 14il mg/jum ta' teriflunomide meta mqabbla ma' 13.6% li kienu qed jirċievu plaċebo.
English: - you have an infection.
Maltese: - għandek infezzjoni.
English: Not measured
Maltese: U KWANTITATTIVA
English: In placebo-controlled studies, no increase in serious infections was observed with teriflunomide 14 mg (2.7%) as compared to placebo (2.2%).
Maltese: Fi studji kkontrollati bi plaċebo, ma ġiet osservata l-ebda żieda f'infezzjonijiet serji b'teriflunomide 14-il mg (2.7%) meta mqabbla mal-plaċebo (2.2%).
English: Teriflunomide is a substrate of the efflux transporter BCRP, which could be involved in direct secretion.
Maltese: Teriflunomide hu substrat tat-trasportatur tal-effluss BCRP, li jista' jkun involut fit-tnixxija diretta.
English: Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Maltese: L-effett ta' teriflunomide fuq substrat CYP2C8: repaglinide Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.7 u 2.4 darbiet rispettivament) ta' repaglinide, wara l-għoti ta' dożi ripetuti ta' teriflunomide, u dan jissuġġerixxi li teriflunomide hu inibitur ta' CYP2C8 in vivo.
English: The recommended elimination procedure is cholestyramine 8 g three times a day for 11 days.
Maltese: Il-proċedura rakkomandata ta' eliminazzjoni hi cholestyramine 8 g tliet darbiet kuljum għal 11-il jum.
English: Week 1 (wallets of 14 and 28) Week 2 (wallets of 14 and 28) Week 3 (wallets of 28) Week 4 (wallets of 28)
Maltese: Ġimgħa 1 (portafolli ta' 14 u 28) Ġimgħa 2 (portafolli ta' 14 u 28) Ġimgħa 3 (portafolli ta' 28) Ġimgħa 4 (portafolli ta' 28)
English: Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8).
Maltese: Każijiet ta' newropatija periferali ġew irrappurtati f'pazjenti li kienu qed jirċievu AUBAGIO (ara sezzjoni 4.8).
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration of teriflunomide should also be undertaken with caution.
Maltese: 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 ta' teriflunomide għandu wkoll isir b'kawtela.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
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' teriflunomide.
English: Breast-feeding women (see section 4.6).
Maltese: Nisa li jkunu qed ireddgħu (ara sezzjoni 4.6).
English: Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects.
Maltese: Teriflunomide 70 mg kuljum dam jingħata sa 14-il jum lil individwi f'saħħithom.
English: New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been reported during the use of teriflunomide.
Maltese: Bidu ġdid ta 'psorjasi (inkluża psorjasi pustulari) u aggravar ta' psorjasi pre-eżistenti ġie rrappurtat waqt lużu ta 'teriflunomide.
English: Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used.
Maltese: Alternattivament, meta cholestyramine ma jkunx disponibbli, 50 g ta' faħam attivat darbtejn kuljum għal 11-il jum jista' jintuża wkoll.
English: From the mean predicted pharmacokinetic parameters calculated from the population pharmacokinetic (PopPK) analysis using data from healthy volunteers and MS patients, there is a slow approach to steadystate concentration (i.e., approximately 100 days (3.5 months) to attain 95% of steady-state concentrations) and the estimated AUC accumulation ratio is approximately 34-fold.
Maltese: Mill-medja tal-parametri farmakokinetiċi mbassra kkalkulati minn analiżi ta' farmakokinetika talpopolazzjoni (PopPK) bl-użu ta' dejta minn voluntiera f'saħħithom u pazjenti b'MS, kien hemm approċċ bil mod lejn il-konċentrazzjoni fl-istat fiss (i.e., madwar 100 jum (3.5 xhur) biex jinkisbu 95% talkonċentrazzjonijiet fl-istat fiss) u l-istima tal-proporzjon ta' akkumulazzjoni tal-AUC hu ta' madwar 34 darba aktar.
English: The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
Maltese: Il-punteġġ medjan tal-EDSS fil linja bażi kien ta' 2.50; 298 pazjent (25.5%) kellhom punteġġ EDSS ta' › 3.5 fil-linja bażi.
English: However, this is most likely an underestimation since extensive organ distribution was observed in rats.
Maltese: Madankollu, wisq probabbli din hi sottovalutazzjoni billi distribuzzjoni estensiva fl-organi ġiet osservata filfirien.
English: AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Maltese: AUBAGIO hu indikat għall-kura ta' pazjenti adulti bi sklerożi multipla (MS) li tirkadi u tbatti.
English: Gammaglutamyltransfer ase (GGT) increaseb, Aspartate aminotransferas
Maltese: Żieda fil-livell ta' aspartate aminotransferaseb
English: Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Maltese: Pakketti bil-folji perforati ta' doża waħda tal-aluminju-polyamide/aluminium/poly(vinyl chloride) f'kartun li fih 10x1 pilloli miksija b'rita.
English: • Educational card for patients
Maltese: • Biljett edukattiv għall-pazjenti
English: The majority of patients had relapsing-remitting multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive relapsing multiple sclerosis (1.7%).
Maltese: Il-maġġoranza tal-pazjenti kellhom sklerożi multipla li tirkadi u tbatti (97.5%), iżda sottogrupp ta' pazjenti kellhom sklerożi multipla sekondarja progressiva (0.8%) jew progressiva li tirkadi (1.7%).
English: Alanine aminotransfer ase (ALT) increaseb
Maltese: Żieda fil-livell ta' alanine aminotransferase (ALT)b
English: Food does not have a clinically relevant effect on teriflunomide pharmacokinetics.
Maltese: L-ikel m'għandu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' teriflunomide.
English: Gender, Elderly, Paediatric patients
Maltese: Sess, Anzjani, Pazjenti pedjatriċi
English: In the pivotal, placebo-controlled studies, the incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.9% (17 patients out of 898) on 14 mg of teriflunomide, compared with 0.4% (4 patients out of 898) on placebo.
Maltese: Fl-istudji l-aktar importanti, ikkontrollati bi plaċebo, l-inċidenza ta' newropatija periferali kkonfermata permezz ta' studji dwar il konduzzjoni fin-nervaturi kienet ta' 1.9% (17-il pazjent minn 898) fuq 14-il mg ta' teriflunomide, meta mqabbla ma' 0.4% (4 pazjenti minn 898) fuq plaċebo.
English: The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%).
Maltese: Il-maġġoranza tal-pazjenti kellhom sklerożi multipla li tirkadi u tbatti (91.5%), iżda sottogrupp ta' pazjenti kellhom sklerożi multipla sekondarja progressiva (4.7%) jew progressiva li tirkadi (3.9%).
English: Fertility was unaffected in rats despite adverse effects of teriflunomide on male reproductive organs, including reduced sperm count.
Maltese: Il-fertilità ma kinitx affettwata fil-firien minkejja l-effetti avversi ta' teriflunomide fuq l-organi riproduttivi maskili, inkluż għadd imnaqqas ta' sperma.
English: Teriflunomide concentrations measured during an 11-day procedure to accelerate teriflunomide elimination with either 8 g cholestyramine three times a day, 4 g cholestyramine three times a day or 50 g activated charcoal twice a day following cessation of teriflunomide treatment have shown that these regimens were effective in accelerating teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations, with cholestyramine being faster than charcoal.
Maltese: Il-konċentrazzjonijiet ta' teriflunomide imkejla waqt proċedura ta' 11-il jum li taċċellera l eliminazzjoni ta' teriflunomide jew b'8 g ta' cholestyramine tliet darbiet kuljum, 4 g ta' cholestyramine tliet darbiet kuljum jew 50 g ta' faħam attivat darbtejn kuljum wara t-twaqqif tal-kura b'teriflunomide, urew li dawn l-iskedi kienu effettivi fl-aċċelerazzjoni tal-eliminazzjoni ta' teriflunomide, u wasslu għal tnaqqis ta' iktar minn 98% fil-konċentrazzjonijiet ta' teriflunomide fil-plażma, b'cholestyramine li jkun aktar mgħaġġel mill-faħam.
English: The median EDSS score at baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline.
Maltese: Ilpunteġġ medjan tal-EDSS fil-linja bażi kien ta' 2.50; 249 pazjent (22.9%) kellhom punteġġ EDSS ta' › 3.5
English: Anemia, decreased platelet counts and effects on the immune system, including leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or lymphoid organs.
Maltese: Anemija, tnaqqis fl-għadd tal-plejtlits u effetti fuq is-sistema immuni, li jinkludu lewkopenija, limfopenija u infezzjonijiet sekondarji, kienu relatati mal-effetti fuq il-mudullun u/jew l-organi limfojdi.
English: Potent cytochrome P450 (CYP) and transporter inducers Co-administration of repeated doses (600 mg once daily for 22 days) of rifampicin (a CYP2B6, 2C8, 2C9, 2C19, 3A inducer), as well as an inducer of the efflux transporters P-glycoprotein [P-gp] and breast cancer resistant protein [BCRP] with teriflunomide (70 mg single dose) resulted in an approximately 40% decrease in teriflunomide exposure.
Maltese: 2C8, 2C9, 2C19, 3A), kif ukoll stimulatur tat-trasportaturi tal-effluss glikoproteina P [P-gp] u proteina reżistenti għall-kanċer tas-sider [BCRP] ma' teriflunomide (doża waħda ta' 70 mg) wasslu għal tnaqqis ta' madwar 40% fl-esponiment għal teriflunomide.
English: Rifampicin and other known potent CYP and transporter inducers such as carbamazepine, phenobarbital, phenytoin and St John's Wort should be used with caution during the treatment with teriflunomide.
Maltese: Rifampicin u stimulaturi magħrufa potenti oħrajn ta' CYP u tat-trasportaturi bħal carbamazepine, phenobarbital, phenytoin u St John's Wort għandhom jintużaw b'kawtela matul it-terapija b'teriflunomide.
English: If both plasma concentrations are below 0.02 mg/l, no risk to the foetus is to be expected.
Maltese: Jekk iż-żewġ konċentrazzjonijiet fil-plażma jkunu taħt 0.02 mg/l, mhux mistenni li jkun hemm riskju għall-fetu.
English: AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14') and engraved with a corporate logo on the other side.
Maltese: AUBAGIO pilloli miksija b'rita (pilloli) ta' 14-il mg huma pilloli, ta' lewn blu ċar sa blu pastell, miksijin b'rita b'forma pentagonali, stampati fuq naħa waħda b'(‘14') u mnaqqxa b'logo tal-korporazzjoni fuq in-naħa l-oħra.
English: Risk difference (CI95%) Relapse-free week 108
Maltese: Rata annwalizzata ta' rikaduta Differenza fir-riskju (CI95%)
English: Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), required for the de novo pyrimidine synthesis.
Maltese: Teriflunomide hu sustanza immunomodulatorja bi propjetajiet antiinfjammatorji li b'mod selettiv u riversibbli jinibixxi l-enzima dihydroorotate dehydrogenase (DHO-DH) tal-mitokondrija, li hi meħtieġa għas-sintesi de novo ta' pyrimidine.
English: An accelerated elimination procedure can be used at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details).
Maltese: Proċedura ta' eliminazzjoni aċċellerata tista' tintuża fi kwalunkwe ħin wara t-twaqqif ta' teriflunomide (ara sezzjonijiet 4.6 u 5.2 għad dettalji tal-proċedura).
English: Thu
Maltese: TL
English: Since AUBAGIO tablets contain lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Maltese: Lactose Billi l-pilloli AUBAGIO fihom il-lactose, pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose,
English: Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Maltese: Pazjenti b'ipoproteinemija severa, eż. fis-sindrome nefrotiku.
English: Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna, l-envelopp protettiv, u l-portafoll wara “JIS''.
English: Cholestyramine or activated charcoal
Maltese: Cholestyramine jew faħam attivat
English: You must use an effective method of contraception during and after treatment with AUBAGIO.
Maltese: Trid tuża metodu effettiv ta' kontraċezzjoni matul u wara l-kura b'AUBAGIO.
English: In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed in patients treated with teriflunomide compared to placebo.
Maltese: Fl-istudji kkontrollati bi plaċebo, tnaqqis medju fl-aċidu uriku fis-serum fuq medda bejn 20 u 30% ġie osservat f'pazjenti kkurati b'teriflunomide meta mqabbel mal-plaċebo.
English: Myalgia, Arthralgia
Maltese: Dijarea, Dardir
English: Not known (frequency cannot be estimated from the available data) - Severe infections (including sepsis) - Severe allergic reactions (including anaphylaxis) - Pulmonary reaction (interstitial lung disease, ILD) - Inflammation of the liver, pancreas, or mouth/lips - Severe skin reactions - Abnormal levels of fats (lipids) in the blood - Psoriasis
Maltese: - Uġigħ wara xi avveniment trawmatiku Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli): - Infezzjonijiet severi (inkluż sepsis) - Reazzjonijiet allerġiċi severi (inkluż anafilassi)
English: The number of patients with permanent treatment discontinuation in the teriflunomide 14 mg group was 22 out of 111 (19.8%), the reasons being adverse events (10.8%), lack of efficacy (3.6%), other reason (4.5%) and lost to follow-up (0.9%).
Maltese: In-numru ta' pazjenti li waqqfu l-kura b'mod permanenti fil-grupp ta' teriflunomide 14-il mg kien ta' 22 minn 111 (19.8%), fejn ir raġunijiet kienu avvenimenti avversi (10.
English: Annualised relapse rate
Maltese: Disturbi taddemm u tassistema limfatika
English: If skin and /or mucosal reactions are observed which raise the suspicion of severe generalised major skin reactions (Stevens-Johnson syndrome, or toxic epidermal necrolysis-Lyell's syndrome), teriflunomide and any other possibly associated treatment must be discontinued, and an accelerated procedure initiated immediately.
Maltese: Stevens-Johnson, jew nekrolisi epidermali tossika-sindrome ta' Lyell), teriflunomide u kwalunkwe kura oħra possibbilment assoċjata jridu jitwaqqfu, u tinbeda proċedura aċċellerata immedjatament.
English: In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8).
Maltese: Fi studji kkontrollati bi plaċebo, l-ebda żieda f'infezzjonijiet serji ma ġiet osservata b'teriflunomide (ara sezzjoni 4.8).
English: The adverse reactions were consistent with the safety profile for teriflunomide in MS patients.
Maltese: Ir-reazzjonijiet avversi kienu konsistenti mal-profil tas-sigurtà għal teriflunomide f'pazjenti b'MS.
English: The primary endpoint was time to a second clinical episode (relapse).
Maltese: Il-punt aħħari primarju kien iż-żmien għat-tieni episodju kliniku (rikaduta).
English: Mild allergic reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Haematological effects
Maltese: Effetti ematoloġiċi
English: Teriflunomide is moderately metabolised and is the only component detected in plasma.
Maltese: Teriflunomide jiġi metabolizzat moderatament u hu l-uniku komponent li ġie osservat fil-plażma.
English: Pollakiuria
Maltese: Tilqim
English: Patients with severe active infection until resolution (see section 4.4).
Maltese: Pazjenti b'infezzjoni severa attiva sakemm ifiequ (ara sezzjoni 4.4).
English: Alopecia was reported as hair thinning, decreased hair density, hair loss, associated or not with hair texture change, in 13.9% of patients treated with 14 mg teriflunomide versus 5.1% in patients treated with placebo.
Maltese: L-alopeċja ġiet irrappurtata bħala xagħar jeħfief, tnaqqis fid-densità tax-xagħar, xagħar jaqa', assoċjati jew le ma' bidla fil-mod kif jinħass ix-xagħar meta tmissu, fi 13.9 % tal-pazjenti kkurati b'14-il mg teriflunomide kontra 5.1 % f'pazjenti kkurati bi plaċebo.
English: - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
Maltese: - cimetidine biex jitnaqqas l-aċidu fl-istonku - zidovudine għal infezzjoni bl-HIV - rosuvastatin, simvastatin, atorvastatin, pravastatin għall-iperkolesterolemija (kolesterol għoli).
English: Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia.
Maltese: Pazjenti b'indeboliment sinifikanti fil-funzjoni tal-mudullun jew anemija, lewkopenija, newtropenija jew tromboċitopenija sinifikanti.
English: Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
Maltese: Fuq perjodu ta' 21 jum, 60.1% tad-doża mogħtija titneħħa mal-ippurgar (37.5%) u l-awrina (22.6%).
English: Effect of teriflunomide 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 teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Maltese: Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.43 u 1.54 darbiet rispettivament) ta' cefaclor, wara l-għoti ta' dożi ripetuti ta' teriflunomide, u dan jissuġġerixxi li teriflunomide hu inibitur ta' OAT3 in vivo.
English: Vomiting, Toothache
Maltese: - Dijarea, tħossok imdardar
English: The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced.
Maltese: L-effett fuq l-għadd ta' ċelluli ħomor tad-demm (RBC) (<2%) u l-għadd tal-plejtlits (<10%) kien inqas notevoli.
English: Teriflunomide is eliminated slowly from the plasma.
Maltese: Teriflunomide jiġi eliminat bil-mod mill-plażma.
English: TOPIC was a double-blind, placebo-controlled study that evaluated once daily doses of teriflunomide 7 mg and 14 mg for up to 108 weeks in patients with first clinical demyelinating event (mean age 32.1 years).
Maltese: TOPIC kien studju double-blind ikkontrollat bil-plaċebo li evalwa dożi ta' darba kuljum ta' teriflunomide 7 mg u 14 mg għal 108 ġimgħa f'pazjenti li kellhom l-ewwel avveniment kliniku ta' telf ta' myelin (età medja ta' 32.1 sena).