FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ventavis 10 microgram/ml nebuliser solution is inhaled using the nebulisers your doctor prescribed (either the Breelib, the Venta-Neb or the I-Neb AAD system).
Maltese: • Is-soluzzjoni għan-nebulizzatur Ventavis 10 mikrogrammi/ml tittieħed man-nifs bl-użu tan-nebulizzaturi li ppreskrivilek it-tabib tiegħek (is-sistema Breelib, Venta-Neb jew INeb AAD).
English: Ventavis 10 mcg/ml 1 ml ampoule white - yellow ring
Maltese: Ventavis 10 mcg/ml ampulla ta' 2 ml ċirku abjad - roża
English: 168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
Maltese: 168 (4 x 42) AMPULLA B'1 ML IPPAKKJATI FLIMKIEN MA' SET TA' OĠĠETTI LI JINTUŻAW FLIMKIEN MA' BREELIB
English: • 3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white - pink).
Maltese: • Ampulli ta' 3 ml, bla kulur, ħġieġ tat-tip I, li fihom 2 ml ta' soluzzjoni għan-nebulizzatur,
English: There is no need to alter the dose in patients with mild or moderate kidney problems (patients with a creatinine clearance >30 ml/min).
Maltese: M'hemmx bżonn tibdel id-doża f'pazjenti bi problemi ħfief jew moderati tal-kliewi (pazjenti bi tneħħija tal-krejatinina ta' > 30 ml/min).
English: • Bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing (see also section 2 “Warnings and precautions”)
Maltese: • Bronkospażmu (tidjiq f'daqqa tal-muskoli fil-ħitan tal-passaġġi ż-żgħar tan-nifs) u tħarħir (ara wkoll sezzjoni 2 “Twissijiet u prekawzjonijiet”)
English: Patients stabilised on one nebuliser should not switch to another nebuliser without close supervision by the treating doctor as different nebulisers have been shown to produce aerosols with slightly different physical characteristics and may have faster delivery of the solution (see section 5.2 of the Summary of Product Characteristics).
Maltese: Pazjenti stabilizzati fuq nebulizzatur wieħed, m'għandhomx jinqalbu għal nebulizzatur ieħor mingħajr superviżjoni mit-tabib li qed jittratta għax nebulizzaturi differenti intwera li jipproduċu aerosols b'karatteristiċi fiżiċi kemmxejn differenti u twassil tas-soluzzjoni li jista' jkun aktar malajr (ara sezzjoni 5.2).
English: The table below provides a summary of the user instructions of the I-Neb for Ventavis:
Maltese: It-tabella ta' hawn taħt tipprovdi sommarju tal-istruzzjonijiet għall-utent ta' I-Neb għal Ventavis:
English: Each ampoule with 1 ml solution contains 20 microgram iloprost.
Maltese: Kull ampulla b'1 ml ta' soluzzjoni fiha 20 mikrogramma ta' iloprost.
English: The mean clearance of iloprost is estimated to be 10 ml/minute/kg.
Maltese: Il-medja tat-tneħħija ta' iloprost hija stmata li tkun 10 ml/minuta/kg.
English: As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
Maltese: Kif mistenni għal prostacycline, iloprost ipproduċa effetti emodinamiċi (vasodilatazzjoni, ħmura tal-ġilda, pressjoni baxxa, inibizzjoni talfunzjoni tal-plejtlits, diffikulta' biex tieħu n-nifs) u sinjali ġenerali ta' avvelenament bħal apatija, disturbi fil-mod kif wieħed jimxi, u tibdil fil-pożizzjoni tal-ġisem.
English: The dose delivered by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc. Each medication chamber is colour coded and has a corresponding colour coded control disc.
Maltese: Kull kompartiment tal-mediċina huwa kkodifikat permezz ta' kulur u għandu disk tal-kontroll korrispondenti kkodifikata permezz ta' kulur.
English: In case of poor tolerability of Ventavis 20 microgram/ml, the dose should be reduced by using 1 ml ampoule of Ventavis 10 microgram/ml (see section 4.4).
Maltese: Ventavis 20 mikrogramma/ml, id-doża għandha titnaqqas billi tintuża ampulla ta' 1 ml ta' Ventavis 10 mikrogrammi/ml (ara sezzjoni 4.4).
English: Vascular disorders
Maltese: defibrotide.
English: Part of a multipack containing 168 (4 x 42) ampoules with 1 ml.
Maltese: Parti minn pakkett multiplu li fih 168 (4 x 42) ampulla ta' 1 ml.
English: The adverse reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated from clinical trial data, are listed under "Frequency not known".
Maltese: Ir-reazzjonijiet avversi identifikati biss waqt issorveljanza ta' wara t-tqegħid fis-suq, u li għalihom il-frekwenza ma tistax tiġi stmata mid-data millprova klinika, huma mniżżla taħt "Frekwenza mhux magħrufa".
English: BATCH NUMBER
Maltese: Bayer OÜ
English: Each ampoule with 1 ml contains 10 microgram iloprost.
Maltese: Kull ampulla b'1 ml fiha 10 mikrogrammi ta' iloprost.
English: • For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc.
Maltese: • Għad-doża ta' 5 mikrogrammi il-kompartiment tal-mediċina bil-lukkett ta' kulur vjola jintuża flimkien mad-disk tal-kontroll vjola.
English: The adverse reactions reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medicinal product and on data from post-marketing surveillance.
Maltese: II u III li nvolvew 131 pazjent li kienu qed jieħdu l-prodott mediċinali u fuq data minn sorveljanza ta' wara t-tqegħid fis-suq.
English: − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Maltese: - Difetti mit-twelid jew miksuba tal-valvoli b'disturbi klinikament rilevanti tal-funzjoni mijokardjali li mhux relatati ma' pressjoni pulmonari għolja.
English: The most frequently observed adverse reactions (≥ 20 %) in clinical trials include vasodilatation (including hypotension), headache and cough.
Maltese: L-aktar reazzjonijiet avversi osservati b'mod frekwenti (≥20%) fi provi kliniċi jinkludu vasodilatazzjoni, (inkuż pressjoni baxxa), uġigħ ta' ras u sogħla.
English: • mouth and tongue irritation including pain
Maltese: • irritazzjoni fil-ħalq u l-ilsien inkluż uġigħ
English: Throat irritation
Maltese: Disturbi vaskulari
English: Nebuliser solution.
Maltese: Soluzzjoni għan-nebulizzatur.
English: The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Maltese: L-aktar reazzjonijiet avversi serji kienu pressjoni baxxa, avvenimenti ta' fsada, u bronkospażmu.
English: In the iloprost group, the median daily inhaled dose was 30 microgram (range 12.5 to 45 microgram/day).
Maltese: Fil-grupp b'iloprost, il-medjan tad-doża ta' kuljum meħudaa man-nifs kienet ta' 30 mikrogramma (b'varjazzjoni minn 12.5 sa 45 mikrogramma/kuljum).
English: Part of a multipack containing 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Maltese: Parti minn pakkett multiplu li fih 168 (4 x 42) ampulla ta' 1 ml ippakkjati flimkien ma' set ta' oġġetti li jintużaw flimkien ma' breelib (li fih biċċa tal-ħalq waħda u kompartiment tal-mediċina wieħed).
English: Ventavis 20 microgram/ml is provided in colourless ampoules, containing 1 ml nebuliser solution.
Maltese: Ventavis 20 mikrogramma/ml hu ipprovdut f'ampulli bla kulur li fihom 1 ml ta' soluzzjoni għan nebulizzatur.
English: Ventavis10 microgram/ml is available in the following packs:
Maltese: Ventavis 10 mikrogrammi/ml huwa disponibbli fil-pakketti li ġejjin:
English: Hypotension, an increase of blood pressure, bradycardia or tachycardia, vomiting, diarrhoea and limb pain might also be possible.
Maltese: Jistgħu jkunu possibbli wkoll pressjoni baxxa, żieda fil-pressjoni, bradikardija jew takikardija, rimettar, dijarea u uġigħ fir-riġlejn.
English: Ampoule coloured rings
Maltese: GĦALL-ĦRUĠ TAL
English: The pre-set dose provided by the I-Neb AAD nebuliser is controlled by the medication chamber in combination with a control disc.
Maltese: Sabiex jiġi żgurat li tirċievi d-doża preskritta, iċċekkja l-kulur tal-kompartiment tal-mediċina u l-kulur tad-disk tal-kontroll.
English: I-Neb AAD Estimated inhalation time
Maltese: I-Neb AAD Lukkett talkompartiment tal-mediċina
English: Tell your doctor if you are taking:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: For the 5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the purple coloured latch is used together with the purple control disc.
Maltese: Għad-doża ta' 5 mikrogrammi ta' Ventavis 10 mikrogrammi/ml il-kompartiment tal-mediċina billukkett ta' kulur vjola jintuża flimkien mad-disk tal-kontroll vjola.
English: For patients being switched from an alternative device to the Breelib nebuliser the first inhalation should be made with Ventavis 10 microgram/ml (1ml ampoule) delivering 2.5 microgram iloprost at the mouthpiece and under close medical supervision to ensure that the faster inhalation provided by Breelib is well tolerated.
Maltese: Għal pazjenti li jkunu qed jinqalbu minn apparat alternattiv għan-nebulizzatur Breelib, l-ewwel inalazzjoni għandha ssir b'Ventavis 10 mikrogrammi/ml (ampulla ta' 1 ml) li jwassal 2.5 mikrogrammi ta' iloprost fil-biċċa tal-ħalq u dan għandu jsir taħt superviżjoni medika mill-viċin biex jiġi żgurat li t-teħid man-nifs aktar malajr ipprovdut minn Breelib huwa ttollerat tajjeb.
English: Packages containing:
Maltese: Pakketti fihom:
English: For Ventavis 20 microgram/ml (5 microgram dose), the medication chamber with the golden coloured latch is used together with the golden control disc.
Maltese: Għal Ventavis 20 mikrogramma/ml (doża ta' 5 mikrogrammi), il-kompartiment talmediċina bil-lukkett ta' kulur id-deheb jintuża flimkien mad-disk tal-kontroll kulur iddeheb.
English: Medication chamber latch
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: Dose of iloprost at mouthpiece Estimated inhalation time
Maltese: Mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli)
English: Systemic exposures exceeded human therapeutic exposures after inhalation by factors of more than 10 (Cmax, cumulative AUC).
Maltese: Esponimenti sistemiċi qabżu l-esponimenti terapewtiċi fil-bniedem wara teħid man-nifs b'fatturi ta' aktar minn 10 (Cmax, AUC kumulattiva).
English: Pharmacokinetics under the specific study conditions of extended inhalation time, were investigated in a randomised, crossover study with 19 healthy adult men following inhalation of single doses of Ventavis 10 microgram/ml and Ventavis 20 microgram/ml (dose of 5 microgram iloprost at the mouthpiece) using the I-Neb.
Maltese: Jekk ma tkunx tista' tittollera inalazzjoni ta' Ventavis 20 mikrogramma/ml kellem lit-tabib tiegħek li jista' jiddeċiedi li għandek tieħu Ventavis 10 mikrogrammi/ml (ampulla ta' 1 ml).
English: EU/1/03/255/004 [30 x 1 ml]
Maltese: EU/1/03/255/008
English: I-Neb AAD 2.5 microgram 5 microgram
Maltese: Ibda t-terapija billi tieħu man-nifs 2.5 mikrogrammi ta'
English: Ventavis 20 microgram/ml nebuliser solution Iloprost
Maltese: Ventavis 20 mikrogramma/ml, soluzzjoni għan-nebulizzatur Iloprost
English: If a pregnancy occurs, taking into account the potential maternal benefit, the use of Ventavis during pregnancy may be considered, only following careful benefit-risk evaluation, in those women who choose to continue their pregnancy, despite the known risks of pulmonary hypertension during pregnancy.
Maltese: Jekk isseħħ tqala, b'kunsiderazzjoni tal benefiċċju potenzjali għall-omm, l-użu ta' Ventavis waqt it-tqala jista' jiġi kkunsidrat biss wara valutazzjoni bir-reqqa tal-benefiċċju u r-riskju, f'dawk in-nisa li jagħżlu li jkomplu t-tqala tagħhom, minkejja r-riskji magħrufa ta' pressjoni pulmonari għolja waqt it-tqala.
English: At initiation of Ventavis treatment with I-Neb system the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 1 ml ampoule of Ventavis 10 microgram/ml.
Maltese: Jekk se tibda trattament b'Ventavis jew jekk se taqleb minn apparat alternattiv, l-ewwel inalazzjoni tiegħek se tkun b'Ventavis 10 mikrogrammi/ml (ampulla ta' 1 ml bi ċrieki ta' lewn abjad u isfar).
English: 6.5 Nature and contents of container Ventavis 10 microgram/ml nebuliser solution
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ventavis 10 mikrogrammi/ml soluzzjoni għan-nebulizzatur
English: Medication chamber latch Control disc
Maltese: Għal kull kompartiment tal-mediċina hemm disk talkontroll b'kodiċi ta' kulur korrispondenti:
English: Ampoule coloured ring Dosage
Maltese: Kif għandek tuża Ventavis
English: ILD may be fatal.
Maltese: ILD jista' jkun fatali.
English: Placebo (N=997)
Maltese: (N=997)
English: EU/1/13/838/001 EU/1/13/838/002 EU/1/13/838/003 EU/1/13/838/004 EU/1/13/838/005
Maltese: EU/1/13/838/001 EU/1/13/838/002 EU/1/13/838/003 EU/1/13/838/004
English: Immune system
Maltese: Sistema immuni
English: Teriflunomide 14 mg (N=1002)
Maltese: Teriflunomide 14-il mg (N=1002)
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 26 Awwissu 2013 Data tal-aħħar tiġdid: 28 Mejju 2018
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Sanofi Belgium
English: Musculoskeletal pain,
Maltese: Uġigħ muskuloskeletriku,
English: • balance problems.
Maltese: • problemi fil-bilanċ.
English: • vision problems
Maltese: • problemi fil-vista
English: EU/1/13/838/001 14 tablets EU/1/13/838/002 28 tablets EU/1/13/838/003 84 tablets EU/1/13/838/004 98 tablets EU/1/13/838/005 10x1 tablet
Maltese: EU/1/13/838/001 14-il pillola EU/1/13/838/002 28 pillola EU/1/13/838/003 84 pillola EU/1/13/838/004 98 pillola EU/1/13/838/005 10x1 pillola
English: Tablet coating hypromellose titanium dioxide (E171) talc macrogol 8000 indigo carmine aluminum lake (E132)
Maltese: Kisja tal-pillola hypromellose titanium dioxide (E171) talc macrogol 8000 indigo carmine aluminum lake (E132)
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)
Maltese: • Alanine aminotransferase/glutamic pyruvic transaminase fis-serum (ALT/SGPT)
English: Tablet core lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Type A) hydroxypropylcellulose magnesium stearate
Maltese: Qalba tal-pillola lactose monohydrate maize starch microcrystalline cellulose sodium starch glycolate (Tip A) hydroxypropylcellulose magnesium stearate
English: Paraesthesia, Sciatica, Carpal tunnel syndrome
Maltese: Parestesija Xjatika, Sindrome talcarpal tunnel,
English: Severe skin reactionsa, Psoriasis (including pustular)b
Maltese: Psoriasi (including pustolosa)b
English: Serious opportunistic infections occurred in 0.2% of each group.
Maltese: Infezzjonijiet opportunistiċi serji seħħew f'0.2% minn kull grupp.
English: AUBAGIO 14 mg
Maltese: AUBAGIO 14-il mg
English: >3 ULN >5 ULN >10 ULN >20 ULN
Maltese: >3 ULN >5
English: TOWER-study
Maltese: Studju TOWER
English: The minor metabolite TFMA (4-trifluoromethylaniline) caused mutagenicity and clastogenicity in vitro but not in vivo.
Maltese: Il-metabolit minuri TFMA (4-trifluoromethylaniline) ikkawża mutaġeniċità u klastoġeniċità in vitro iżda mhux in vivo.
English: - The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Tip A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
English: Pancreatitis, Stomatitis
Maltese: Pankreatite, Stomatite
English: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne France
Maltese: Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne Franza
English: Also contains: lactose.
Maltese: Fih ukoll: lactose.
English: Immunosuppressive or immunomodulating therapies
Maltese: Terapiji immunosoppressivi jew immunomodulanti
English: - you have respiratory symptoms.
Maltese: - għandek sintomi respiratorji.
English: Effect of teriflunomide on BCRP and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Maltese: L-effett ta' teriflunomide fuq BCRP u/jew substrati ta' polypeptide B1 u B3 li jittrasportaw l-anjoni organiċi (OATP1B1/B3)
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: Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study
Maltese: Tabella 1 - Riżulatati Ewlenin ( għad-doża approvata, popolazzjoni ITT)
English: Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS).
Maltese: Pazjenti bi stati ta' immunodefiċjenza severa, eż. is-sindromu ta' immunodefiċjenza akkwiżita (AIDS).
English: Rash, Acne
Maltese: Raxx, Akne
English: Following discontinuation of teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 99.9% at the completion of day 11.
Maltese: Wara t-twaqqif tal-kura b'teriflunomide u l-għoti ta' cholestyramine 8 g tliet darbiet kuljum, il konċentrazzjoni ta' teriflunomide fil-plażma tonqos bi 52% fl-aħħar ta' jum 1, 91% fl-aħħar ta' jum 3, 99.2% fl-aħħar ta' jum 7, u 99.9% fit-tmiem ta' jum 11.
English: AUBAGIO contains lactose (a type of sugar).
Maltese: AUBAGIO fih lactose (tip ta' zokkor).
English: Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in plasma.
Maltese: Teriflunomide jeħel b'mod estensiv mal-proteina fil-plażma (> 99%), probabbilment mal-albumina, u jiġi ddistribwit primarjament fil-plażma.
English: Acute hepatitis
Maltese: Epatite akuta
English: Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola fiha 72 mg ta' lactose (bħala monohydrate).
English: Frequencies were defined using 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-frekwenzi ġew definiti blużu tal-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: Polyamide/aluminium/poly(vinyl chloride) -aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Maltese: Folji tal-aluminju-polyamide/aluminium/poly(vinyl chloride) imdaħħlin ġo portafolli (14 u 28 pillola miksija b'rita) u ppakkjati f'kartun li fih 14, 28, 84 (3 portafolli ta' 28), u 98 (7 portafolli ta' 14) pillola miksija b'rita.
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC Code: L04AA31
Maltese: Immunosoppressanti, Immunosoppressanti selettivi, Kodiċi ATC:
English: Hazard ratio (CI95%)
Maltese: Proporzjon ta' periklu (CI95%)
English: AUBAGIO 14 mg tablets teriflunomide
Maltese: AUBAGIO 14-il mg pilloli teriflunomide
English: Common Uncommon Rare Very rare
Maltese: Mhux komuni Rari
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Maltese: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Franza
English: In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
Maltese: F'studji kkontrollati bil-plaċebo, il-frekwenzi għal astenja kienu ta' 2.0%, 1.6% u 2.2% fil-grupp ta' plaċebo, teriflunomide 7 mg u teriflunomide 14 mg ,rispettivament.
English: Teriflunomide 14 mg/day was not superior to interferon beta1a on the primary endpoint: the estimated percentage of patients with treatment failure at 96 weeks using the Kaplan-Meier method was 41.1% versus 44.4% (teriflunomide 14 mg versus interferon beta-1a group, p=0.595).
Maltese: Kaplan-Meier kienet ta' 41.1% kontra 44.4% (teriflunomide 14-il mg kontra l-grupp ta' interferon beta-1a, p=0.595).
English: The risk of a second clinical attack over 2 years was 35.9% in the placebo group and 24.0% in the teriflunomide 14 mg treatment group (hazard ratio: 0.57, 95% confidence interval: 0.38 to 0.87, p=0.0087).
Maltese: Ir-riskju tat-tieni attakk kliniku fuq sentejn kien ta' 35.9% fil-grupp tal-plaċebo u ta' 24.0% fil-grupp ta' kura ta' teriflunomide 14 mg (proporzjon ta' periklu: 0.57, 95% intervall ta' kunfidenza: 0.38 sa 0.87, p=0.0087).
English: Secondary pathways involve oxidation, N-acetylation and sulfate conjugation.
Maltese: Rotot sekondarji jinvolvu ossidazzjoni, N-acetylation u konjugazzjoni ta' sulfate.
English: AUBAGIO contains lactose
Maltese: AUBAGIO fih lactose
English: ALT >3 ULN and TBILI >2 ULN
Maltese: ALT >3 ULN u TBILI >2 ULN 5/994 (0.5%)
English: The number of patients with permanent treatment discontinuation in the subcutaneous interferon beta-1a group was 30 out of 104 (28 .8%), the reasons being adverse events (21.2%), lack of efficacy (1.9%), other reason (4.8%) and poor compliance to protocol (1%).
Maltese: interferon beta-1a mogħti taħt il-ġilda kien ta' 30 minn 104 (28 .8%), fejn ir-raġunijiet kienu avvenimenti avversi (21.2%), nuqqas ta'effikaċja (1.9%), raġuni oħra (4.8%) u l-protokoll ma ġiex segwit kif suppost
English: Accelerated Elimination Procedure: Cholestyramine and activated charcoal
Maltese: Proċedura ta' Eliminazzjoni Aċċellerata: Cholestyramine u faħam attivat
English: In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS.
Maltese: Fi sklerożi multipla, l-infjammazzjoni teqred il-kisja protettiva (imsejħa myelin) madwar in-nervaturi fisCNS.
English: Several sources of intrinsic variability were identified in healthy subjects and MS patients based on the PopPK analysis: age, body weight, gender, race, and albumin and bilirubin levels.
Maltese: Diversi sorsi ta' varjabilità intrinsika ġew identifikati f'individwi f'saħħithom u pazjenti b'MS ibbażat fuq lanaliżi PopPK: età, piż tal-ġisem, sess, razza, u livelli ta' albumina u bilirubina.
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared with warfarin alone.
Maltese: Madankollu, ġie osservat tnaqqis ta' 25% filproporzjon normalizzat internazzjonali (INR) massimu meta teriflunomide ingħata flimkien ma' warfarin meta mqabbel ma' warfarin waħdu.
English: A total of 2267 patients were exposed to teriflunomide (1155 on teriflunomide 7 mg and 1112 on teriflunomide 14 mg) once daily for a median duration of about 672 days in four placebo-controlled studies (1045 and 1002 patients for teriflunomide 7 mg and 14 mg, respectively) and one active comparator study (110 patients in each of the teriflunomide treatment groups) in patients with relapsing forms of MS (Relapsing Multiple Sclerosis, RMS).
Maltese: 14-il mg) darba kuljum għal tul medjan ta' madwar 672 ġurnata f'erba' studji kkontrollati bi plaċebo (1045 u 1002 pazjent għal teriflunomide 7 mg u 14-il mg, rispettivament) u studju komparatur attiv wieħed (110 pazjenti f'kull wieħed mill-gruppi ta' kura b'teriflunomide) f'pazjenti b'forom ta' sklerożi multipla li tirkadi (Sklerożi Multipla li Tirkadi, RMS).
English: Dyslipidaem ia
Maltese: Ma tkejjilx
English: A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Maltese: 618-il pazjent intgħażlu b'mod arbitrarju biex jirċievu 7 mg (n=205) jew 14-il mg (n=216) ta' teriflunomide jew plaċebo (n=197).