FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substances phenylephrine and ketorolac.
Maltese: Omidria fih s-sustanzi attivi fenilefrina u ketorolak.
English: It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances that are involved in pain and inflammation processes.
Maltese: Din taħdem billi timblokka lenzimi msejħin ċikloossiġenażi, li jipproduċu l-prostaglandini, sustanzi involuti fl-uġigħ u fil-proċessi ta' infjammazzjoni.
English: Omidria is a medicine used in adults during lens replacement surgery in the eye to keep the pupil dilated (widened) and prevent its contraction, and to reduce eye pain after surgery.
Maltese: Omidria huwa mediċina li tintuża f'adulti waqt operazzjoni ta' sostituzzjoni tal-lenti tal-għajn biex ilħabba tinżamm miftuħa (imwessa') u jipprevjeni il-kontrazzjoni tagħha, u biex inaqqas l-uġigħ fl-għajn wara l-operazzjoni.
English: Omidria is available as a concentrate that is made up into an irrigation solution (a solution used to rinse the inside of the eye during surgery).
Maltese: Omidria jiġi bħala konċentrat li jiġi magħmul f'soluzzjoni għal irrigazzjoni (soluzzjoni użata biex tlaħlaħ ġewwa l-għajn matul il-kirurġija).
English: - The active substance is rasagiline.
Maltese: - Is-sustanza attiva hi rasagiline.
English: Tablet 30 tablets
Maltese: Pillola 30 pillola
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets
Maltese: 7 pilloli 10 pilloli 28 pillola 30 pillola 100 pillola 112-il pillola
English: EU/1/04/304/001 EU/1/04/304/002 EU/1/04/304/003 EU/1/04/304/004 EU/1/04/304/005 EU/1/04/304/006
Maltese: EU/1/04/304/001 EU/1/04/304/002 EU/1/04/304/003 EU/1/04/304/004
English: AZILECT 1 mg tablets
Maltese: AZILECT 1 mg pilloli
English: 21 September 2009
Maltese: 21 ta' Settembru 2009
English: Musculoskeletal pain,
Maltese: Uġigħ muskolu skeletriku,
English: AZILECT 1 mg tablets rasagiline
Maltese: AZILECT 1 mg pilloli rasagiline
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Maltese: aminoindan, 3-hydroxy-N-propargyl-1 aminoindan u 3-hydroxy-1-aminoindan.
English: Dystonia,
Maltese: Depressjoni,
English: For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8.
Maltese: (SSRIs)/ inibituri selettivi tal-ġbir mill-ġdid ta' serotonin-norepinephrine (SNRIs) ara sezzjoni 4.8.
English: Skin melanoma*
Maltese: Melanoma fil ġilda*
English: - Flatulence - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Maltese: - Uġigħ muskolu-skeletriku - Infjammazzjoni tal-ġogi (arttrite) - Tirżiħ u dgħjufija fil-muskoli tal-idejn (sindrome ta' carpal tunnel) - Tnaqqis fil-piż - Ħolm mhux normali - Diffikultà fil-koordinazzjoni muskolari (ataksja) - Depressjoni - Sturdament (vertigo) - Kontrazzjonijiet muskolari mtawla (distownja)
English: Teva Sweden AB Tel: + 46 42 12 11 00
Maltese: Tel: + 46 42 12 11 00
English: 21 February 2005
Maltese: 21 ta' Frar 2005
English: Musculoskeletal and connective tissue disorders*
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi*
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Maltese: Episodji ta' ngħas eċċessiv matul il-ġurnata (EDS - excessive daytime sleepiness) u rqad f'daqqa (SOS - sudden sleep onset)
English: In vitro studies showed that rasagiline at a concentration of 1 µg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Maltese: rasagiline 1 mg), ma jinibixxix isoenzimi taċ-ċitokrom P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19,
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Maltese: Il-pilloli issibhom f'folji ta' 7, 10, 28, 30, 100 jew 112 pilloli jew ġo flixkun ta' 30 pillola.
English: Each tablet contains 1 mg of rasagiline (as mesilate).
Maltese: Kull pillola fiha 1 mg rasagiline (bħala mesilate).
English: Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group.
Maltese: f'rasagiline 1 mg bħala terapija viċin il-grupp ta' terapija b'levodopa vs. inċidenza ta' 1/388 (0.3%) fil-grupp tal-plaċebo.
English: There is no relevant use of AZILECT in children and adolescents.
Maltese: M'hemm l-ebda użu rilevanti ta' AZILECT fi tfal u adolexxenti.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Maltese: Fi studji kliniċi f'pazjenti bil-marda ta' Parkinson l-aktar reazzjonijiet avversi komuni kienu: uġigħ ta' ras, depressjoni, vertigo, u influwenza (influwenza u rinite) fil-monoterapija; diskajneżja, pressjoni ortostatika baxxa, waqgħat, uġigħ fl-addome, tqalligħ u rimettar, u nixfa fil-ħalq flimkien ma' terapija b'levodopa; uġigħ muskoluskeletriku, bħal uġigħ fid-dahar u l-għonq, u artralġja fiż-żewġ korsijiet.
English: Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Maltese: Is-sintomi rrappurtati wara doża eċċessiva ta' AZILECT jinkludu burdata kemmxejn ewforika (forma ħafifa ta' manija), pressjoni għolja ħafna u sindrome ta' serotonin (ara sezzjoni 4).
English: The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Maltese: L-użu ta' AZILECT flimkien ma' mediċini kontra d-depressjoni li fihom fluoxetine u fluvoxamine għandhom jiġu evitati.
English: Results of five tyramine challenge studies (in volunteers and Parkinson's disease patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Maltese: flimkien ma' risultati ta' monitoraġġ id-dar ta' l-pressjoni ta'd-demm wara l-ikel (ta' 464 pazjent li rċievew 0.5 jew 1 mg/ġurnata ta' rasagiline jew plaċebo bħala terapija miżjuda ma' levodopa għal sitt xhur mingħajr restrizzjonijiet għal tyramine), flimkien ma' l-fatt li ma kienx hemm rapporti ta' interazzjoni bejn tyramine/rasagiline fl-istudji kliniċi mingħajr restrizzjonijiet għal tyramine, wrew li rasagiline jista' jintuża mingħajr periklu bla restizzjonijiet ta' tyramine fid-dieta.
English: The data collected suggests that Parkinson's disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Maltese: Parkinson, u mhux xi prodott mediċinali partikolari, li hija assoċjata ma' riskju ogħla ta' kanċer talġilda (mhux esklusivament melanoma).
English: Very common (may affect more than 1 in 10 people) - Involuntary movements (dyskinesia) - Headache
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - Uġigħ addominali - Waqgħat - Allerġija
English: At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Maltese: trattament b'rasagiline u l-bidu ta' trattament b' fluoxetine u fluvoxamine.
English: ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Maltese: Provi kliniċi ta' rasagiline ma ppermettewx l-użu fl-istess waqt ta' fluoxetine jew fluvoxamine ma' rasagiline iżda kienu permessi l-antidepressanti u d-dożi li ġejjin fil-provi ta' rasagiline: amitriptyline ≤ 50 mg/jum, trazodone ≤ 100 mg/jum, citalopram ≤ 20 mg/jum, sertraline ≤ 100 mg/jum, u paroxetine ≤ 30 mg/jum (ara sezzjoni 4.5).
English: The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
Maltese: disturbi fil-kontroll tal-impulsi, imġiba impulsiva, kleptomanija, serq, ħsibijiet ossessivi, disturb ossessiv-kompulsiv, stereotipija, logħob tal-ażżard, logħob tal-ażżard patoloġiku, żieda fil-libido,
English: *See section description of selected adverse reactions
Maltese: * Ara s-sezzjoni deskrizzjoni ta' reazzjonijiet avversi magħżula
English: The secondary measures of efficacy included global assessments of improvement by the examiner, Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON. Rasagiline produced statistically significant benefit compared to placebo.
Maltese: punti ta' l-iskala sekondarja Attivitajiet tal-Ħajja ta' Kuljum (ADL) meta fi stat “OFF” u UPDRS tal moviment meta fi stat “ON”. Rasagiline ħalla titjib li huwa statistikament sinifikanti meta mqabbel ma' plaċebo.
English: Arthralgia, Neck pain
Maltese: Artralġja, Uġigħ fl-għonq
English: Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Maltese: - Attakk tal-qalb (infart mijokardijaku) - Raxx bl-infafet ( raxx vesikolubulluż)
English: In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
Maltese: Sustanzi li jaffettwaw l-attività ta' CYP1A2 Studji dwar il-metaboliżmu in vitro indikaw li ċ-ċitokrom P450 1A2 (CYP1A2) huwa l-enzim prinċipali risponsabli għall-metaboliżmu ta' rasagiline.
English: The robustness of the results for the primary efficacy endpoint, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Maltese: Il-qawwa tar-riżulati għall-konklużżjoni ta' l-effikaċja primarja kienet ikkonfermata b'sensiela ta' mudelli statistiċi addizzjonali u kienet murija fi tlett cohorts (ITT, skond il protokol u completers).
English: Especially tell your doctor if you are taking any of the following medicines: - Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) - The antibiotic ciprofloxacin used against infections - The cough suppressant dextromethorphan - Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Maltese: impedituri selettivi tal-ġbir mill-ġdid ta' serotonin-norepinephrine, mediċini triċikliċi u tetraċikliċi kontra d-depressjoni) - L-antibijotiku ciprofloxacin li jintuża kontra l-infezzjonijiet - Il-mediċina kontra s-sogħla dextromethorphan - Simpatomimetiċi bħal dawk fit-taqtir tal-għajnejn, f'dekonġestjonanti ta' l-imnieħer u f'dawk li jittieħdu mill-ħalq u prodotti mediċinali kontra l-irjiħat li fihom ephedrine u pseudoephedrine.
English: There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Maltese: Indutturi ta' CYP1A2 Hemm riskju li f'pazjenti li jpejpu, l-livelli fil-plażma ta' rasagiline jistgħu jinżlu minħabba l induzzjoni ta' l-enzim CYP1A2 li hu risponsabli għall-metaboliżmu.
English: In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Maltese: F'pazjenti bil-marda ta' Parkinson li jirċievu rasagiline bħala terapija miżjuda ma' trattament kroniku b'levodopa, ma kien hemm l-ebda effett klinikament sinifikanti tat-trattament b'levodopa fuq it tneħħija ta' rasagiline.
English: You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Maltese: Trid tistenna mill-inqas 14-il ġurnata wara li twaqqaf it-trattament b' AZILECT qabel ma tibda trattament b'impeditur ta' MAO jew b'pethidine.
English: Conjugation of rasagiline and its metabolites was also found to be a major elimination pathway to yield glucuronides.
Maltese: eliminazzjoni huwa l-konjugazzjoni ta' rasagiline u l-prodotti ta' l-metaboliżmu biex jiffurmaw glukoronidi.
English: In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
Maltese: Fi studju I, 404 pazjent kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (138 l pazjent), rasagiline 1 mg/ġurnata (134 l-pazjent) jew rasagiline 2 mg/ġurnata (132 l-pazjent).
English: Carpal tunnel syndrome, Balance disorder accident syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Maltese: Effetti dopaminerġiċi Episodji ta' ngħas eċċessiv matul il-ġurnata (EDS - excessive daytime sleepiness) u rqad f'daqqa
English: Additional cases of malignant melanoma were reported during post-marketing period.
Maltese: Każijiet addizzjonali ta' melanoma malinna kienu rrappurtati matul il-perjodu ta'
English: Concomitant use of rasagiline and levodopa
Maltese: Urġenza biex tgħaddi l-awrina
English: In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 26 weeks.
Maltese: Fi studju III, il-pazjenti kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (159 l pazjent), rasagiline 0.5 mg/ġurnata (164 l-pazjent) jew rasagiline 1 mg/ġurnata (149 l-pazjent).
English: In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
Maltese: Fi studju II, il-pazjenti kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (229 l pazjent), jew rasagiline 1 mg/ġurnata (231 l-pazjent) jew 200 mg ta' entacapone impeditur ta'
English: Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline, or when taking concomitant medications that increase plasma levels of rasagiline (e.g. ciprofloxacin) (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu avżati dwar l-effetti addittivi li jista' jkollhom prodotti mediċinali sedattivi, alkoħol, jew depressanti oħra tas-sistema nervuża ċentrali (eż. benzodiazepines, antipsikotiċi,
English: CYP1A2 inhibitors
Maltese: N04BD02
English: CYP1A2 inducers
Maltese: CYP2D6, CYP2E1, CYP3A4 u CYP4A.
English: Ex vivo and in vitro experiments demonstrate that rasagiline is neither inhibitor nor inducer of major CYP450 enzymes (see section 4.5).
Maltese: enzimi CYP450 maġġuri (ara sezzjoni 4.5).
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Maltese: Ngħas eċċessiv matul il-ġurnata (ipersomnija, letarġija, sedazzjoni, episodji ta' irqad f'daqqa, ħedla, irqad f'daqqa) jistgħu jseħħu f'pazjenti kkurati b'agonisti ta' dopamine u/jew kuri dopaminerġiċi oħra.
English: In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
Maltese: Fil-perijodu ta' wara t-tqegħid fis-suq, kien hemm każ wieħed ta' żieda fil-pressjoni tad-demm f'pazjenti li kien qed juża l-vasoristrettur oftalmiku tetrahydrozoline hydrochloride waqt li kien qed jieħu rasagiline.
English: EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
Maltese: 1 kunjett (b'qiegħ ċatt)
English: (Invented) name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/05/322/001 Yttriga vial (glass) 1 vial (V-shaped bottom)
Maltese: Il-pakkett Daqs tal-pakkett
English: 4 (4 x 1) prefilled syringes (multipack)
Maltese: 4 (4 x 1) siringi mimlijin għal-lest (Pakkett multiplu)
English: Adults 18 to 60
Maltese: Adulti 18 sa 60
English: EU/1/97/047/004 EU/1/97/047/005 EU/1/97/047/006 EU/1/97/047/009 EU/1/97/047/007 EU/1/97/047/008
Maltese: EU/1/97/047/006 EU/1/97/047/009 EU/1/97/047/007 EU/1/97/047/008
English: Common to < 1/10
Maltese: Komuni to < 1/10
English: No MedDRA 17.1 PT was retrieved.
Maltese: Ebda PT ta' MedDRA 17.1 ma nkiseb.
English: 1, 28700 San Sebastian de los Reyes, Madrid Spain
Maltese: Desvio Algete, Km. 1, 28700 San Sebastian de los Reyes, Madrid Spanja
English: Rash k; urticaria
Maltese: Raxx k; urtikarja
English: deep vein thrombosis*; thrombosis*; thrombophlebitis*
Maltese: trombożi profonda filvini*; trombożi*; tromboflebite*
English: Age Group (years)
Maltese: Grupp ta' età (snin)
English: Superior vena cava syndrome i,
Maltese: Sindrome tal-vena cava superjuri i,
English: BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
Maltese: BeneFIX 1000 BeneFIX 1500 BeneFIX 2000
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Awwissu 1997 Data tal-aħħar tiġdid: 20 ta' Lulju 2012
English: Lot Pfizer Europe MA EEIG
Maltese: Pfizer Europe MA EEIG
English: Baseline n = 24 Mean ± SD
Maltese: Linja bażi n = 24 Medja ± SD
English: A summary of pharmacokinetic data is presented in Table 1.
Maltese: Sommarju tad-dejta farmakokinetika huwa ppreżentat f'Tabella 1.
English: Store below 30 ºC.
Maltese: Aħżen f'temperatura taħt 30ºC.
English: It is important that the recommendations in section 4.2 be followed closely.
Maltese: Huwa importanti li r-rakkomandazzjonijiet f'sezzjoni 4.2 jiġu segwiti mill-qrib.
English: Solvent Sodium chloride solution
Maltese: Solvent Soluzzjoni ta' sodium chloride
English: Adolescents 12 to < 18
Maltese: Adolexxenti 12 sa < 18
English: Month 6 n = 23 Mean ± SD
Maltese: Xahar 6 n = 23 Medja ± SD
English: Powder Sucrose Glycine L-Histidine Polysorbate 80
Maltese: Sucrose Glycine L-histidine Polysorbate 80
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, see section 4.4.
Maltese: Hemm riskju potenzjali ta' episodji tromboemboliċi wara l-għoti ta' prodotti ta' fattur IX, ara sezzjoni 4.4.
English: Τηλ: +357 22 817690 Latvija
Maltese: Τηλ: +357 22 817690
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-infużjoni kull 8 - 24 siegħa sakemm ma tibqax fil-periklu.
English: Minor:
Maltese: Minuri:
English: • Development of neutralising antibodies (inhibitors)
Maltese: • Żvilupp ta' antikorpi newtralizzanti (inibituri)
English: FIX consumption for routine prophylaxis in 22 evaluable patients was 4607 ( 1849) IU/kg per year and 378 ( 152) IU/kg per month.
Maltese: Il-konsum ta' FIX għal profilassi ta' rutina fit-22 pazjent evalwabbli kien ta' 4607 ( 1849) IU/kg fis-sena u 378 ( 152)
English: 1 vial with 250 IU nonacog alfa 1 vial with 500 IU nonacog alfa 1 vial with 1000 IU nonacog alfa 1 vial with 1500 IU nonacog alfa 1 vial with 2000 IU nonacog alfa 1 vial with 3000 IU nonacog alfa
Maltese: IU nonacog alfa kunjett 1 b'1000 IU nonacog alfa kunjett 1 b'1500 IU nonacog alfa kunjett 1 b'2000 IU nonacog alfa kunjett 1 b'3000 IU nonacog alfa
English: * ADR identified post-marketing a including cellulitis b low-titer transient inhibitor formation c including drug hypersensitivity, angioedema, bronchospasm, wheezing, dyspnoea, and laryngospasm d including migraine, sinus headache e including scintillating scotoma and blurred vision f including heart rate increased, sinus tachycardia g including hot flush, feeling hot, skin warm h including blood pressure decreased i superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion of BeneFIX through a central venous catheter j including productive cough k including rash macular, rash papular, rash maculopapular l developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode.
Maltese: * ADR identifikata wara t-tqegħid fis-suq inkluża ċellulite formazzjoni ta' inibitur temporanju b'titer baxx inklużi sensittività eċċessiva għall-mediċina, anġjoedema, bronkospażmu, tħarħir, dispnea u larinġospażmu inklużi emigranja, uġigħ ta' ras minħabba s-sinus inklużi skotoma xintillanti u vista mċajpra inklużi żieda fir-rata tat-taħbit tal-qalb, takikardja minħabba sinus inklużi fwawar tas-sħana, tħossok sħun/a, ġilda sħun/a inkluż tnaqqis fil-pressjoni tad-demm sindrome tal-vena cava superjuri (SVC) fi trabi tat-twelid morda b'mod kritiku, filwaqt li jirċievu infużjoni kontinwa ta' BeneFIX permezz ta' katiter venuż ċentrali inkluża sogħla produttiva inklużi raxx makulari, raxx papulari, raxx makulopapulari żviluppat f'pazjent pożittiv għall-antikorp tal-epatite C 12-il jum wara doża ta' BeneFIX għal episodju ta'
English: Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis
Maltese: Parametri Farmakokinetiċi  SD Medji Bbażati fuq Stimi ta' Bayes Individwali minn Analiżi Farmakokinetika tal-Popolazzjoni
English: Administration (Intravenous Injection):
Maltese: Għoti (Injezzjoni ġol-vina):
English: Each vial of BeneFIX contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU of nonacog alfa.
Maltese: Kull kunjett ta' BeneFIX nominalment fih 250, 500, 1000, 1500, 2000 jew 3000 IU ta' nonacog alfa.
English: Abbreviations: AUC∞ = area under the plasma concentration-time curve from time zero to infinity; Cmax = peak concentration; t1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.
Maltese: AUC∞ = erja taħt il-kurva tal-konċentrazzjoni-ħin tal-plażma mill-ħin żero sa infinità; Cmax = konċentrazzjoni massima; t1/2 = half-life ta' eliminazzjoni mill-plażma; CL = eliminazzjoni; SD = devjazzjoni standard.
English: LIST OF EXCIPIENTS Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80.
Maltese: Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80
English: - After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains 50, 100, 200, 300, 400 or 600 IU/ml (see Table 1).
Maltese: - Wara r-rikostituzzjoni bis-solvent ipprovdut (soluzzjoni ta' 0.234% sodium chloride), kull kunjett fih 50, 100, 200, 300, 400 jew 600
English: • Vision impairment (including blurred vision, appearance of spots/lights)
Maltese: • Indeboliment fil-vista (inklużi vista mċajpra, dehra ta' tikek/dwal)
English: CL (mL/hr/kg) Recovery (IU/dL per IU/kg)
Maltese: CL (mL/hr/kg) Irkupru (IU/dL għal kull IU/kg)
English: Other medicines and BeneFIX
Maltese: Mediċini oħra u BeneFIX