FrancophonIA/ELRC3.0 huggingface dataset:
English: Chills, pyrexia, fatigue*, Influenza-like illness
Maltese: deni, għeja kbira*, mard bħal dak tal influwenza
English: • for the degarelix 240/80 mg treatment group 19.8 ng/ml (interquartile range: P25 9.4 ng/ml, P75
Maltese: P25 9.4 ng/ml, P75 46.4 ng/ml) għall-grupp tal-kura b'degarelix
English: The clearance of degarelix when administered as single intravenous doses (0.864-49.4 µg/kg) in healthy elderly men was found to be 3550 ml/h/kg.
Maltese: Instab li t-tneħħija ta' degarelix, meta mogħti bħala dożi waħidhom ġol-vini (0.864-49.4 µg/kg) f'irġiel anzjani b'saħħithom, kienet ta' 35-50 ml/siegħa/kg.
English: Ferring Lääkkeet Oy Puh/Tel: +358 207 401 440 info@ferring.fi
Maltese: +358 207 401 440 info@ferring.fi
English: The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a monthly 80 mg injection.
Maltese: Id-doża rakkomandata hi ta' żewġ injezzjonijiet konsekuttivi ta' 120 mg.
English: 1 ml of the reconstituted solution contains 20 mg degarelix.
Maltese: Kull kunjett fih 120 mg ta' degarelix.
English: FIRMAGON 80 mg powder and solvent for solution for injection
Maltese: FIRMAGON 80 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: FIRMAGON 120 mg powder and solvent for solution for injection
Maltese: FIRMAGON 120 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Package leaflet: Information for the user FIRMAGON 120 mg powder and solvent for solution for injection
Maltese: Informazzjoni għall-utent FIRMAGON 120 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Detach the syringe from the vial adapter and attach the needle for deep subcutaneous injection to the syringe.
Maltese: Aqla' s-siringa minn mal-adapter tal-kunjett u waħħal il-labra mas-siringa għal injezzjoni profonda taħt il-ġilda.
English: 3 vials with powder containing 80 mg of degarelix and 3 pre-filled syringes with 4.2 ml of solvent.
Maltese: 3 kunjetti bi 80 mg ta' degarelix (trab) u 3 siringi mimlija għal-lest b'4.2 ml ta' solvent.
English: Degarelix is subject to common peptidic degradation during the passage of the hepato-biliary system and is mainly excreted as peptide fragments in the faeces.
Maltese: Degarelix hu suġġett għal degradazzjoni peptidika komuni matul il-passaġġ mis-sistema epatobiljari u jitneħħa primarjament bħala bċejjeċ tal-peptide fl-ippurgar.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for degarelix, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal degarelix, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Maltese: Effett fuq l-intervall QT/QTc It-terapija fit-tul bi privazzjoni tal-androgen tista' ttawwal l-intervall QT. Fl-istudju konfermatorju li qabbel
English: − increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
Maltese: − żieda fil-piż, nawsja, dijarea, livelli għolja ta' xi enzimi tal-fwied
English: These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration.
Maltese: Dawn l-avvenimenti seħħew primarjament bid-doża tal-bidu, filwaqt li matul it-terapija tal-manteniment bid-doża ta' 80 mg, l-inċidenza ta' dawn l-avvenimenti għal kull 100 injezzjoni kienet: 3 għall-uġigħ u <1 għall-eritema, nefħa, formazzjoni ta' għoqod u ebusija.
English: Precautions must be taken to avoid accidental injection into a vein.
Maltese: Għandhom jittieħdu prekawzjonijiet biex tiġi evitata injezzjoni aċċidentali ġo vina.
English: Package leaflet: Information for the user FIRMAGON 80 mg powder and solvent for solution for injection
Maltese: Informazzjoni għall-utent FIRMAGON 80 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Musculoskeletal pain and discomfort
Maltese: Uġigħ u skonfort muskoloskeletriku
English: Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ml.
Maltese: Rispons li rnexxa fl-istudju kien definit bħala l-kisba ta' kastrazzjoni medika f'jum 28 u l-manteniment sa jum 364 fejn lanqas waħda mill-konċentrazzjoni tat-testosterone ma kienet akbar minn 0.5 ng/ml.
English: The distribution volume in healthy elderly men is approximately 1 l/kg.
Maltese: Il-volum tad-distribuzzjoni f'irġiel anzjani b'saħħithom hu ta' madwar 1 l/kg.
English: Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Maltese: Id-dożaġġ tal-manteniment ta' kull xahar ta' 80 mg irriżulta fi trażżin sostnut tat testosterone f'97% tal-pazjenti għal mill-inqas sena.
English: Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients.
Maltese: QT/QTcs li kienu jaqbżu 450 msek f'madwar 20% tal-pazjenti.
English: Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Maltese: Pazjenti b'disturb epatiku magħruf jew issuspettat ma kinux inklużi fi provi kliniċi fit-tul b'degarelix.
English: Testicular pain, breast pain, pelvic pain, genital irritation, ejaculation failure
Maltese: Uġigħ testikulari, uġigħ fis-sider, uġigħ pelviku, irritazzjoni ġenitali, insuffiċjenza fl ejakulazzjoni
English: Liver transaminases increased
Maltese: Lasta tal-planġer
English: 2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.
Maltese: 2 kunjetti bit-trab li jkun fihom 120 mg ta' degarelix u 2 siringi mimlija għal-lest bi 3 ml ta' solvent.
English: In 4 of the 8 cases, the causal relationship between degarelix and the event could not be ruled out; the cases were well documented, without evident alternative aetiology or confounding factors, with compatible time-to-onset and positive dechallenge and increased blood CPK.
Maltese: F'4 mit-8 każijiet, irrelazzjoni kawżali bejn degarelix u l-avveniment ma setgħetx tiġi eskluża; il-każijiet kienu dokumentati tajjeb, mingħajr etjoloġija jew fatturi ta' tfixkil alternattivi evidenti, b'ħin għall-bidu u dechallenge pożittiva kumpatibbli u żieda fis-CPK fid-demm.
English: 1 injection needle
Maltese: 1 labra għall-injezzjoni
English: Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years.
Maltese: 29% tal-pazjenti wara kura b'FIRMAGON għal sa 5.5 snin.
English: EXP
Maltese: − telqa
English: Plunger rod
Maltese: OĦRAJN
English: In conclusion, rhabdomyolysis should be added to the list of ADRs of the Product Information with a frequency rare.
Maltese: Għalhekk huwa konkluż li rabdomijolożi għandha tiżdied mal-lista ta' reazzjonijiet avversi tat-Tagħrif dwar il-Prodott bi frekwenza ta' rari.
English: How to store FIRMAGON
Maltese: X'fih FIRMAGON
English: Pack size
Maltese: Bijotrasformazzjoni
English: − excessive sweating (including night sweats), rash
Maltese: − għaraq eċċessiv (li jinkludi għaraq matul il-lejl), raxx
English: The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse reactions.
Maltese: III (N=409) kienu minħabba l-effetti fiżjoloġiċi mistennija tat-trażżin tat-testosterone, li jinkludu fwawar u żieda fil-piż (irrappurtati f'25% u 7%, rispettivament, tal-pazjenti li kienu qed jirċievu l kura għal sena), jew reazzjonijiet avversi fil-post fejn tingħata l-injezzjoni.
English: Due to the risk of microbial contamination, this medicine should be used immediately.
Maltese: Minħabba r-riskju ta' kontaminazzjoni mikrobjali, din il-mediċina għandha tintuża immedjatament.
English: 240 mg administered as two consecutive subcutaneous injections of 120 mg each
Maltese: 240 mg mogħtija bħala żewġ injezzjonijiet konsekuttivi taħt il-ġilda ta' 120 mg kull waħda
English: Pack-size of 2 trays containing:
Maltese: Daqs tal-pakkett ta' 2 trejs li jkun fih:
English: If you get any of the side effects, talk to your doctor.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Musculoskeletal , connective tissue and bone disorders
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi u tal-għadam
English: EMEA/V/C/118
Maltese: EMEA/V/C/118 RAPPORT TA' VALUTAZZJONI
English: Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Maltese: Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it can no longer cause the disease).
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2008.
English: The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens.
Maltese: Il-vajrus użat fil-vaċċin iġorr l-antiġeni H5 (haemagglutinin 5) u n-N2 (neuramidase 2).
English: This summary was last updated on 05/09/2006.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fil- 09.2006.
English: Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component.
Maltese: Għasafar vaċċinati jistgħu jiġu differenzjati b'identifikazzjoni minn għasafar infettati permezz ta' test dijanjostiku għal antikorpi kontra l-komponent N2.
English: • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Maltese: • Jekk il-vajrus ta' l-influwenza avjarju li jiċċirkola għandu komponent N differenti mill-N2li jinsab fil-vaċċin, jista' jkun possibbli li wieħed jagħmel differenza bejn vaċċin minn għasfur infettat u dak vaċċinat permezz ta' test dijanjostiku sabiex jiġu misjuba antikorpi Neuraminidase.
English: The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2.
Maltese: Il-kumpanija wetqet studji ta' laboratorju fuq is-sigurtà bl-użu ta' vaċċin simili ħafna għal Nobilis Influenza H5N2.
English: Other information about Nobilis Influenza H5N2:
Maltese: Informazzjoni oħra dwar l-Influwenza Nobilis H5N2:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H5N2
Maltese: PUBBLIKA EWROPEW (EPAR) INFLUWENZA NOBILIS H5N2 Sommarju EPAR għall-pubbliku
English: Nobilis Influenza H5N2 is a vaccine.
Maltese: L-Influwenza Nobilis H5N2 huwa vaċċin.
English: Nobilis Influenza H5N2 has been authorised under “Exceptional Circumstances”.
Maltese: Influwenza Nobilis H5N2 ġie awtorizzat taħt “Ċirkustanzi Eċċezzjonali”.
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N2.
Maltese: Barra minn hekk, il-kumpanija vverifikat is-sigurtà ta' tliet lottijiet ta' produzzjoni standard ta' Nobilis Influenza H5N2.
English: Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza.
Maltese: Nobilis Influenza H5N2 huwa vaċċin użat għat-tiġieġ sabiex jiġu protetti kontra l-influwenza avjarja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N2 to Intervet International BV on 01/09/2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea, għall-Influweza Nobilis H5N2 lil Intervet International BV fil-01.09.2006.
English: The European Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
Maltese: Reproduction is authorised provided the source is acknowledged
English: What is the risk associated with Nobilis Influenza H5N2?
Maltese: X'inhu r-riskju assoċjat ma' l-Influwenza Nobilis H5N2?
English: What is Nobilis Influenza H5N2?
Maltese: Kif ġiet studjata l-Influwenza Nobilis H5N2?
English: (1=terrible to 7=delighted).
Maltese: (1=terribbli sa 7=kuntent ħafna).
English: The more points = worse symptoms.
Maltese: Iktar punti = aggravar tas-sintomi.
English: INFORMATION IN BRAILLE FIRDAPSE
Maltese: INFORMAZZJONI BIL-BRAILLE FIRDAPSE
English: Raynaud's syndrome
Maltese: Sindromu ta' Raynaud
English: MedDRA Preferred term
Maltese: MedDRA Terminu ppreferut
English: • The active substance is amifampridine.
Maltese: • Is-sustanza attiva hi amifampridine.
English: MedDRA System organ class
Maltese: Sistema tal-klassifika tal-organi MedDRA
English: FIRDAPSE 10 mg tablets amifampridine
Maltese: FIRDAPSE 10 mg pilloli amifampridine
English: • Sedatives (e.g. barbiturates)
Maltese: • Sedattivi (eż. barbiturati)
English: Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Maltese: Medda tal-punteġġ totali QMG 0 - 39, 13-il oġġett, 0-3 punti f'kull test.
English: LS Mean Diff (95% CI) p-valued
Maltese: Diff fil-Medja ta' LS (CI ta' 95%) valur pd
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Maltese: FARMAĊEWTIKA U KONTENUT 100 pillola
English: Placebo (n=13)
Maltese: Plaċebo (n=13)
English: • Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine)
Maltese: • Mediċini għal problemi mentali (eż. haloperidol, carbamazapine, chlorpromazine, clozapine)
English: Mean (SD) p-valuee a
Maltese: Medja (SD) valur pe a
English: Diarrhoea, epigastralgia
Maltese: Dijarea, epigastralġja
English: Observed mean difference in QMG Total and SGI change from baseline score between treatments were -6.54 (95% CI: -9.78, -3.29; p=0.0004) and 2.95 (95% CI: 1.53, 4.38; p=0.0003) respectively, both statistically significant in favour of amifampridine phosphate.
Maltese: Id-differenza medja osservata fil-QMG Totali u l-bidla fl-SGI mill-punteġġ fil-linja bażi bejn it-trattamenti kienet ta' -6.54 (CI ta' 95%: -9.78, -3.29; p=0.0004) u 2.95 (CI ta' 95%: 1.53, 4.38; p=0.0003) rispettivament, it-tnejn statistikament sinifikanti favur amifampridine phosphate.
English: QMG Scoresa
Maltese: Punteġġi QMGa
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data).
Maltese: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1,000), Rari ħafna (< 1/10,000) u Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: b SGI is a 7-point scale which rates the global impression of the effects of study treatment
Maltese: b SGI hija skala ta' 7 punti li tikklassifika l-impressjoni globali tal-effetti tat-trattament tal-istudju
English: Date of latest renewal: 1 December 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Diċembru 2009 Data tal-aħħar tiġdid: 1 ta' Diċembru 2014
English: (hr) mean(S.D.), range t1/2
Maltese: (hr) medja (S.D.), firxa t1/2
English: A prospective, placebo-controlled, randomised study in 26 patients with Lambert-Eaton myasthenic syndrome (LEMS) reported clinical efficacy for amifampridine at the standard recommended maximum dose of 60 mg/day (Sanders et al 2000).
Maltese: Studju prospettiv, randomised, ikkontrollat bil-plaċebo fuq 26 pazjent bis-sindrome mijasteniku ta' Lambert-Eaton (LEMS) irrapporta effikaċja klinika għal amifampridine fid-doża massima rrakkomandata standard ta' 60 mg/ġurnata (Sanders et al 2000).
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland
Maltese: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 L-Irlanda
English: Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1
Maltese: Ipoaestesija orali1, paraestesiji orali1, paraestesiji periferali u peribukkali, dardir1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/601/001
English: • Weakness, tiredness, headache
Maltese: • Indeboliment, għeja, uġigħ ta' ras
English: • The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
Maltese: • Is-sustanzi l-oħra huma microcrystalline cellulose, anhydrous colloidal silica u calcium stearate.
English: Carcinogenicity risk
Maltese: Riskju ta' karċinoġenità
English: • Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion)
Maltese: • Antidepressanti - antidepressanti triċikliċi (eż. clomipramine, amoxapine), inibituri selettivi tat-teħid ta' serotonin (eż. citalopram, dapoxetine) u antidepressanti atipiċi (eż. buproprion)
English: Fed* (N=46)
Maltese: Stat mitmugħ* (N=46)
English: The results from the in vitro CYP450 inhibition study indicate amifampridine is unlikely to play a role in metabolic-based clinical drug-drug interactions related to inhibition of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 metabolism of co-administered medicinal products.
Maltese: Ir-riżultati mill-istudju in vitro dwar l-inibizzjoni ta' CYP450 jindikaw li amifampridine mhux probabbli li jkollu rwol fl-interazzjoni klinika bejn mediċina u oħra bbażat fuq il-metaboliżmu relatat mal-inibizzjoni tal-metaboliżmu ta' CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, u CYP3A4 prodotti mediċinali mogħtija flimkien.
English: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Maltese: Kura sintomatika tas-sindromu mijasteniku ta' Lambert-Eaton (LEMS) f'adulti.
English: The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
Maltese: Id-doża rrakkomandata tal-bidu hija 15 mg amifampridine kuljum, li tista' tiżdied f'inkrementi ta' 5 mg kull 4 sa 5 ijiem, sa massimu ta' 60 mg fil-ġurnata.
English: AUC0-∞ (ng·hr/ml)
Maltese: AUC0-∞ (ng·h/ml)
English: Subjects (N) NAT2 Phenotype
Maltese: Individwi (N) Fenotip ta' NAT2
English: Table 1: Adverse Reactions Reported with FIRDAPSE
Maltese: Tabella 1: Reazzjonijiet Avversi
English: Elevated liver enzyme levels (transaminases)
Maltese: Livelli għoljin ta' enzimi tal-fwied (transaminases)
English: (ng·hr/ml )
Maltese: (ng·h/ml)
English: • Medicines for malaria (e.g. halofantrine and mefloquine)
Maltese: • Mediċini kontra l-malarja (eż. halofantrine u mefloquine)
English: Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Maltese: Il-pazjenti kellhom età medjana ta' 55.5 snin (medda: 31 sa 75 sena) u 62% kienu nisa u 38% kienu rġiel.
English: • In patients with congenital QT syndromes (see section 4.4)
Maltese: • F'pazjenti b'sindromi konġenitali tal-QT (ara sezzjoni 4.4)
English: Renal Status
Maltese: Stat Renali
English: NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
Maltese: FIS-SUQ BioMarin International Limited
English: Medicinal products with atropinic effects
Maltese: Prodotti mediċinali b'effetti tal-atropina
English: Dizziness1, hypoaesthesia1, paraesthesia1
Maltese: Sturdament1, ipoestesija1, paraestesija1
English: • Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine)
Maltese: • Mediċini għall-kura ta' allerġiji - antistamini (eż. terfenadine, astemizole, cimetidine)
English: In a study of healthy volunteers, systemic exposure of amifampridine was notably influenced by the overall metabolic acetylation activity of NAT enzymes and NAT2 genotype.
Maltese: Fi studju fuq voluntiera f'saħħithom, l-esponiment sistemiku għal amifampridine kien influwenzat b'mod partikolari mill-attività globali ta' aċetalizzazzjoni metabolika tal-enzimi NAT u tal-ġenotip NAT2.
English: Assessment
Maltese: Evalwazzjoni
English: Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state.
Maltese: B'mod simili Cmax u AUC0-∞ kienu ogħla fi stat sajjem milli fi stat mitmugħ.
English: The 3-N-acetyl metabolite exposure by AUC0-∞ was up to 6.8-fold higher in slow acetylators and up to 4-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Maltese: L-esponiment għal metabolit 3-N-acetyl skont l-AUC0-∞ kien sa 6.8 darbiet ogħla f'acetylators bil-mod u sa 4 darbiet ogħla f'acetylators mgħaġġla b'indeboliment renali sever meta mqabbel ma' individwi b'funzjoni renali normali.
English: Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study.
Maltese: Pazjenti li użaw reċentement terapiji immunomodulatorji (eż azathioprine, mycophenolate, cyclosporine), rituximab, immunoglobulina G mogħtija ġol-vini, u plażmaferesi kienu esklużi mill-istudju.
English: • Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
Maltese: • Mediċini biex jirrilassaw il-muskoli - (eż. mivacurium, pipercurium, suxamethonium)
English: The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4.
Maltese: Il-punti aħħarin primarji kienu bidla mil-linja bażi (CFB - change from baseline) fil-punteġġ tal-Impressjoni Globali tal-Pazjent (SGI - Subject Global Impression) u Myasthenia Gravis Kwantitattiva (QMG - Quantitative Myasthenia Gravis) f'Jum 4.
English: AUC0-∞ (ng·hr/ml) Mean (S.D.), range
Maltese: AUC0-∞ (ng·hr/ml) Medja (S.D.), firxa
English: In humans, 93.2% to 100% of amifampridine is excreted into the urine within 24 hours after dosing as amifampridine (19%) and its 3-N-acetylated amifampridine metabolite (74.0% to 81.7%).
Maltese: Fil-bnedmin, 93.2% sa 100% ta' amifampridine jitneħħa fl-awrina fi żmien 24 siegħa wara ddożar bħala amifampridine (19%) u l-metabolita tiegħu 3-N-acetylated amifampridine (74.0% sa 81.
English: Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Maltese: Amifampridine ma kellux effett tossika fuq il-ġeni f'serje standard ta' testijiet in vitro u in vivo.
English: anti-Parkinson medicinal products, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.
Maltese: H1, antikolinerġiċi, prodotti mediċinali kontra l-marda ta' Parkinson, antispasmodiċi atropiniċi, disopyramide, newrolettiċi phenothiazine u clozapine.
English: Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Maltese: Għandha tingħata kura ta' sostenn kif indikat klinikament, fosthom monitoraġġ mill-qrib tas-sinjali vitali.
English: In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3).
Maltese: Fi studju dwar il-karċinoġenità djetetika li dam sentejn, Schwannomas beninji u malinja kienu osservati fil-firien ittrattati b'amifampridine (ara sezzjoni 5.3).
English: It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
Maltese: Huwa jtejjeb is-saħħa tal-muskoli u d-daqs tar-resting compound muscle action potential (CMAP) b'differenza medja globali peżata ta' 1.69 mV (95% CI 0.60 għal 2.77).