FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nervesparing prostatectomy.
Maltese: Mhux magħruf jekk CIALIS huwiex effettiv f'pazjenti li għaddew minn kirurġija fil-pelvis jew prostatettomija radikali fejn in-nervituri ma' ġewx salvati.
English: Therefore this combination is not recommended (see section 4.4).
Maltese: (ara sezzjoni 4.4).
English: What CIALIS looks like and contents of the pack CIALIS 20 mg is a yellow film-coated tablet in the shape of an almond and has "C 20" marked on one side.
Maltese: CIALIS 20 mg hija pillola safra miksija b'rita,f'forma ta' lewża u mmarkata b'"C 20" fuq naħa waħda.
English: Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Maltese: darba aktar potenti għal PDE5 milli għal PDE6, li hija enżima li tinsab fir-retina u li hija responsabbli għall-fototransduzzjoni.
English: Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below.
Maltese: Saru studji ta' interazzjoni dwar tadalafil ta' 10 mg u/jew 20 mg, kif indikat hawn taħt.
English: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Maltese: Każijiet kardjovaskulari serji, fosthom infart mijokardijaku, mewt kardijaku għal għarrieda, angina pectoris instabbli, arritmija ventrikulari, puplesija, attakki iskemiċi transitorji, uġigħ fis-sider,
English: Do not take CIALIS if you are already taking nitrates.
Maltese: Tiħux CIALIS jekk diġà qed tieħu n-nitrati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/237/001-005, 009
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/237/001-005, 009
English: In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined.
Maltese: Fi studji ta' farmakoloġija klinika, il-potenzjal biex tadalafil iżid l-effetti ipotensivi ta' prodotti mediċinali li jintużaw kontra l-pressjoni għolja kien eżaminat.
English: Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).
Maltese: Għalkemm ma ġewx studjati interazzjonijiet speċifiċi, inibituri oħra tal-enżima protease, bħal saquinavir, u inibituri oħrajn ta' CYP3A4, bħal erythromycin, clarithromycin, itraconazole u meraq talgrejpfrut għandhom jingħataw flimkien b'kawtela minħabba li huma mistennija li jżidu lkonċentrazzjonijiet ta' tadalafil fil-plażma (ara sezzjoni 4.4).
English: In clinical trials with tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Maltese: F'studji kliniċi b'tadalafil 5 mg meħud darba kuljum għall-kura tal-iperplażja beninna tal-prostata, l-isturdament u d dijarea ġew irrapportati b'mod aktar frekwenti f'pazjenti 'l fuq minn 75 sena.
English: These effects were not associated with changes in other parameters such as motility, morphology and FSH.
Maltese: tibdil fil-parametri l-oħra bħal motilità, morfoloġija u FSH.
English: The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.
Maltese: Ir-riżultati totali ta' sigurtà kienu fil-parti l-kbira konsistenti mal-profil ta' sigurtà magħruf ta' tadalafil u bl-avvenimenti avversi mistennija f'popolazzjoni pedjatrika b'DMD li qiegħda tirċievi l-kortikosterojdi.
English: In the primary efficacy studies, 75 % of intercourse attempts were successful in CIALIS treated patients as compared to 32 % with placebo.
Maltese: Fl-istudji dwar effikaċja primarja, 75% tal-attentati għall-kopulazzjoni kienu b'suċċess f'pazjenti li ħadu CIALIS meta mqabbel ma' 32% li ħadu lplaċebo.
English: Elderly men
Maltese: TA' EĊĊIPJENTI
English: NAME OF THE MEDICINAL PRODUCT CIALIS 20 mg tablets tadalafil
Maltese: Kull pillola fiha 20 mg tadalafil
English: LIST OF EXCIPIENTS lactose
Maltese: Tfal u adolexxenti
English: Once-a-day dosing of CIALIS both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2).
Maltese: Dożaġġ ta' darba kuljum ta' CIALIS għall-kura kemm tad-disfunzjoni erettili u kemm tal-iperplażja beninna tal-prostata ma ġiex evalwat f'pazjenti b'indeboliment epatiku; għalhekk jekk jiġi miktub mittabib, dan għandu jagħmel evalwazzjoni bir-reqqa tal-benefiċċju/riskju għal kull pazjent (ara s sezzjonijiet 4.4 u 5.2).
English: - other medicines to treat high blood pressure.
Maltese: - mediċini oħra għal kura ta' pressjoni għolja fid-demm.
English: Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Maltese: Ibbażat fuq ir-riżultati ta' studju kliniku li fih 150 individwu irċievew doża ta' 20 mg tadalafil kuljum għal 7 ijiem u 0.4 mg nitrogliċerina taħt l-ilsien f'ħinijiet diversi, din linterazzjoni damet aktar minn 24 siegħa u ma dehritx aktar meta għaddew 48 siegħa minn l-aħħar doża ta' tadalafil.
English: Method of administration CIALIS is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Maltese: Metodu ta' kif għandu jingħata CIALIS hu disponibbli bħala pilloli miksija b'rita ta' 2.5, 5, 10 u 20mg għall-użu orali.
English: PHARMACOLOGICAL PROPERTIES
Maltese: Prodotti mediċinali antidijabetiċi
English: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Maltese: (3) Irrapportat bi frekwenza akbar meta tadalafil ġie mogħti lill-pazjenti li kienu diġa qed jieħdu prodotti mediċinali kontra l-pressjoni.
English: There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Maltese: Hemm informazzjoni klinika limitata dwar is-sigurta' ta' teħid ta' doża waħda ta'CIALIS f'pazjenti b'insuffiċjenza severa tal-fwied (Child-Pugh Klassi C); It-teħid ta' doża darba kuljum ma ġietx evalwata f'pazjenti b'insuffiċjenza epatika.
English: How to take CIALIS
Maltese: X'fih CIALIS
English: Each tablet contains 10 mg of tadalafil.
Maltese: Kull pillola fiha 10 mg ta' tadalafil.
English: Cytochrome P450 metabolised medicinal products Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Maltese: Tadalafil mhux mistenni li b'mod klinikament sinifikanti jinibixxi jew jinduċi it-tneħħija ta' prodotti mediċinali metabolizzati minn iżoformi ta' CYP450.
English: Prolonged erections Priapism, Penile haemorrhage,
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Imnieħer miżdud Qtugħ ta' nifs,
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25 % higher exposure (AUC) relative to healthy subjects aged 19 to 45 years.
Maltese: Anzjani b'saħħithom (65 sena jew akbar) kellhom tneħħija aktar baxxa ta' tadalafil meħud oralment, li rriżulta f 25% aktar esponiment (AUC) meta mqabbel ma' individwi b'saħħithom ta' età minn 19 sa 45 sena.
English: Therefore there is the potential of drug interactions mediated by inhibition of transporters.
Maltese: Għalhekk hemm il-potenzjal ta' interazzjonijiet tal-mediċina minħabba inibizzjoni tat-trasportaturi.
English: - have serious heart disease or recently had a heart attack within the last 90 days.
Maltese: - Pazjenti li kellhom infart kardijaku fl-aħħar 90 jum,
English: Riociguat
Maltese: Sturdament
English: Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited.
Maltese: Id-dejta hija limitata għal pazjenti 'l fuq minn 65 sena li qed jirċievi tadalafil f'studji kliniċi jew għallkura tad-disfunzjoni eretilli jew għall-kura tal-iperplażja beninna tal-prostata.
English: - an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
Maltese: - alpha blocker (użat għal kura ta' pressjoni għolja tad-demm jew għas-sintomi urinarji assoċjati ma' iperplażja beninna tal-prostata). - mediċini oħra għal kura ta' pressjoni għolja fid-demm.
English: Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
Maltese: Analiżi ta' tagħrif osservazzjonali tissuġġerixxi żieda fir-riskju ta' NAION akuta f'irġiel b'disfunzjoni eretilli wara espożizzjoni għal tadalafil jew inibituri oħra ta' PDE5.
English: Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes.
Maltese: Tadalafil (10 mg ħlief fi studji b'imblokkaturi tar-reċetturi angiotensin II u amlodipine fejn intużat doża ta' 20 mg) ma kellu lebda interazzjoni klinikalment sinifikanti ma' l-ebda waħda minn dawn il-klassijiet.
English: Read the package leaflet before use.
Maltese: Jista jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: CIALIS 10 mg film-coated tablets Aluminium/PVC blisters in cartons of 4 film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC f‘kartuniet ta' 4 pillola miksijin b'rita.
English: Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiates the hypotensive effect of nitrates (see section 4.3).
Maltese: Tadalafil għandu karatteristiċi vasodilatorji, li jirriżultaw fi tnaqqis ħafif u temporajnu fil-pressjoni tad-demm (ara sezzjoni 5.1) u b'hekk jikkawża l-effett ipotensiv tan-nitrati (ara sezzjoni 4.3).
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be clinically relevant.
Maltese: F'pazjenti li jirċievu prodotti mediċinali għall-pressjoni għolja flimkien ma'tadalafil 20 mg, dan jista' jinduċi tnaqqis fil-pressjoni tad-demm, li (bl-eċċezzjoni ta' imblokkaturi tar-riċetturi alpha -ara hawn fuq-) huwa ġeneralment ħafif u x' aktarx ma jkunx klinikament rilevanti.
English: Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Maltese: Studji in vitro wrew li tadalafil huwa inibitur selettiv ta' PDE5.
English: Light yellow and almond shaped tablets, marked "C 5" on one side.
Maltese: Pilloli ta' kulur isfar ċar u għandhom forma ta' lewża, immarkati "C 5” fuq naħa waħda.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg tadalafil LIST OF EXCIPIENTS lactose See leaflet for further information.
Maltese: Id-doża tista' titnaqqas għal 2.5 mg darba kuljum skond it-tollerabilità individwali.
English: These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.
Maltese: Ma' dawn l-effetti vaskulari jista' jiżdied ukoll l-inibizzjoni tal-attività tan-nervituri afferenti tal-bużżieqa tal-awrina u rrilassament tal-muskolu involontarju tal-prostata u tal-bużżieqa tal-awrina.
English: - Keep this leaflet.
Maltese: Barra minn hekk,
English: NAME OF THE MEDICINAL PRODUCT CIALIS 10 mg tablets tadalafil
Maltese: Kull pillola fiha 10 mg tadalafil
English: Headache
Maltese: UŻU
English: Dyspnoea, Epistaxis
Maltese: Kif għandek tieħu CIALIS darba kuljum
English: CIALIS 20 mg film-coated tablets Tadalafil
Maltese: CIALIS 20 mg pilloli miksijin b'rita Tadalafil
English: Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction.
Maltese: Il-farmakokinetiċi determinati f'popolazzjoni magħżula b'pazjenti b'disfunzjoni erettili huma simili għall-farmakokinetiċi f'individwi mingħajr disfunzjoni erettili.
English: For the treatment benign prostatic hyperplasia The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
Maltese: Id-doża rakkmandata tal-bidu hija pillola ta' 10 mg qabel l-attivita' sesswali.
English: CIALIS, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Maltese: fibrozi kavernożali jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jistgħu jippredisponuhom għal prijapiżmu (bħal sickle cell enemija, majeloma multipla jew lewkimja).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly Nederland B.V.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data tal-iskadenza li tidher fuq il-kartuna u l-folja wara ‘JIS'.
English: This effect lasts at least twelve hours and may be symptomatic, including syncope.
Maltese: Dan l-effett idum għallinqas 12-il siegħa u jista' jkun sintomatiku u jinkludi s-sinkope.
English: Anti-hypertensives (including calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Maltese: It-teħid flimkien ta' doxazin (4 u 8 mg kuljum) u tadalafil (doża ta' 5 mg kuljum u doża waħda ta'
English: (2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
Maltese: (2) Reazzjonijiet avversi rrapportati waqt is-sorveljanza wara li l-prodott tqiegħed fis-suq li ma kinux osservati f'studji kliniċi kkontrollati bil-plaċebo.
English: Facial oedema2, Sudden cardiac death1, 2
Maltese: Konvulżjonijiet2, Amnesija tranżitorja
English: Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.
Maltese: Intwera li tadalafil iżid il-bijodisponibilita' orali ta' ethinylestradiol; żieda simili tista' tkun mistennija bit-teħid orali ta' terbutaline, għalkemm il-konsegwenza klinika ta' din mhix ċerta.
English: MRD positive
Maltese: MRD negattiv
English: LIST OF EXCIPIENTS Excipient: sucrose.
Maltese: TA' EĊĊIPJENTI Eccipjent: sucrose.
English: Asparaginase activity
Maltese: Attività ta' asparaginase
English: Difference (95 % CIa)
Maltese: Differenza (95% CI
English: 0 (0 - 2) h
Maltese: 0 (0 - 2) sigħat
English: • Pancreatitis.
Maltese: • Pankreatite.
English: Table 1 System organ class
Maltese: Tabella 1 Sistema tal-klassifika tal organi
English: The active substance is asparaginase.
Maltese: • Is-sustanza attiva hi asparaginase.
English: Spectrila can induce antibodies of different immunoglobulin classes (IgG, IgM, IgE).
Maltese: Spectrila jista' jinduċi antikorpi ta' klassijiet differenti ta' immunoglobulina (IgG, IgM, IgE).
English: Asparaginase hydrolyses asparagine to aspartic acid and ammonia.
Maltese: Asparaginase jidrolizza asparagine għal aspartic acid u ammonia.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: • anaphylaxis,
Maltese: • epatotossiċità,
English: Area under the curve (AUC0-72h)
Maltese: Żona taħt il-kurva (AUC0-72h)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 January 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 14 Jannar 2016
English: Maximum serum concentration (Cmax)
Maltese: Konċentrazzjoni massima fis-serum (Cmax)
English: Name and address of the manufacturer of the biological active substance Wacker Biotech GmbH
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Wacker Biotech GmbH
English: - age 6 - 12 months:
Maltese: - età ta' 6 - 12-il xaħar:
English: EU/1/15/1072/002 (5 vials)
Maltese: EU/1/15/1072/002 (5 kunjetti)
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2 °C - 8 °C).
English: Disseminated intravascular coagulation (DIC), anaemia, leukopenia, thrombocytopenia
Maltese: Koagulazzjoni intravaskulari mifruxa (DIC), anemija, lewkopenija, tromboċitopenija
English: > 10 times ULN).
Maltese: transaminases > 10 darbiet tal-ULN).
English: Table 4: Pharmacokinetic parameters of Spectrila in 14 children/adolescents
Maltese: Tabella 4: Parametri farmakokinetiċi ta' Spectrila f'14-il tifel/tifla/adolexxenti
English: Ischaemic strokes are rare.
Maltese: Aċċessjonijiet iskemiċi huma rari.
English: 17.33 (12.54 - 22.91) h
Maltese: 17.33 (12.54 - 22.91) siegħa
English: Common Depression, hallucination, confusion
Maltese: Komuni Depressjoni, alluċinazzjoni, konfużjoni
English: 0.053 (0.043 - 0.178) l/h
Maltese: 0.053 (0.043 - 0.178) l/siegħa
English: • accumulation of fluid (oedema)
Maltese: • akkumulazzjoni ta' fluwidu (edema)
English: • depression, hallucination or confusion
Maltese: • depressjoni, alluċinazzjoni, konfużjoni
English: Time to Cmax
Maltese: Ħin għas-Cmax
English: Increase in amylase, lipase, abnormal electroencephalogram (EEG) (reduced alpha wave activity, increased theta and delta wave activity)
Maltese: Żieda f'amylase, lipase, elettroenċefalogramma anormali (EEG) (tnaqqis fl-attività tal-alpha wave, żieda fl-attività tat-theta u d-delta wave)
English: Table 3: Efficacy results (MC-ASP.5/ALL; Full analysis set)
Maltese: Tabella 3: Riżultati tal-effikaċja (MC-ASP.5/ALL;
English: Patients received 5,000 U/m² asparaginase (Spectrila versus a reference E.coli- asparaginase) at days 12, 15, 18, 21, 24, 27, 30, and 33 of induction treatment.
Maltese: Il-pazjenti rċivew 5,000 U/m² ta' asparaginase (Spectrila kontra E. coli-asparaginase ta' referenza) f'jiem 12, 15, 18, 21, 24, 27, 30, u 33 tal-kura ta' induzzjoni.
English: Glucocorticoids and/ or anticoagulants
Maltese: Glukokortikojdi u/jew antikoagulanti
English: • Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases
Maltese: • Indeboliment sever tal-fwied (bilirubina > 3 darbiet tal-limitu ta' fuq tan-normal [ULN];
English: 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: 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: Median (range) serum trough asparaginase activities on days 18, 25, and 33 were 209 (42 - 330) U/l, 130 (6 - 424) U/l, and 32 (1 - 129) U/l, respectively.
Maltese: Il-medjan (medda) tal-attivitajiet minimi ta' asparaginase fis-serum f'jiem 18, 25, u 33 kienu ta' 209 (42 - 330) U/L, 130 (6 - 424)
English: The mean (Standard Deviation, SD) of the volume of distribution at steady state (Vdss) was 2.47 l (0.45 l).
Maltese: Il-medja (Devjazzjoni standard, SD) tal-volum ta' distribuzzjoni fl-istat fiss (Vdss) kienet ta' 2.47 l (0.45 l).
English: Asparagine depletion in serum was complete in 11 of 12 patients (92%).
Maltese: It-tnaqqis ta' asparagine fis-serum kien komplet ħlief fi 11 minn 12-il pazjent (92%).
English: • acute pancreatitis,
Maltese: • pankreatite akuta,
English: Median (range)
Maltese: Medjan (medda)
English: A higher risk of thrombosis during induction therapy with asparaginase and prednisone was seen in children with a genetic prothrombotic risk factor (factor V G1691A-mutations, prothrombin G20210A-variation, methylenetetrahydrofolate reductase [MTHFR] T677T-genotype, increased lipoprotein A, hyperhomocysteinaemia).
Maltese: Riskju ogħla ta' trombożi matul it-terapija ta' induzzjoni b'asparaginase u prednisone ġie osservat fi tfal b'fattur ta' riskju protrombotiku ġenetiku (mutazzjonijiet f'G1691A ta' fattur V, varjazzjoni ta' G20210A ta' prothrombin, ġenotip T677T ta' methylenetetrahydrofolate reductase [MTHFR], żieda f'lipoproteina A, iperomoċisteinemija).
English: CI = confidence interval; CSF = cerebrospinal fluid; MRD = minimal residual disease a
Maltese: CI = intervall ta' kunfidenza; CSF = fluwidu ċerebrospinali;
English: Spectrila will not be used:
Maltese: Spectrila mhux se jintuża:
English: Antineoplastic agents
Maltese: Mediċini antineoplastiċi
English: To avoid this, vincristine is usually given 3 - 24 hours before asparaginase.
Maltese: Biex dan jiġi evitat, vincristine normalment jingħata 3 - 24 siegħa qabel asparaginase.
English: Asparaginase is produced by recombinant DNA technology in a microorganism named Escherichia coli.
Maltese: Asparaginase issir minn teknoloġija ta' DNA rikombinanti f'mikroorganiżmu li jismu Escherichia coli.
English: • high blood levels of ammonia (hyperammonaemia)
Maltese: • livelli għoljin ta' ammonia (iperammonaemija)
English: During induction treatment, asparaginase-typical adverse drug reactions like elevated liver enzymes/bilirubin (≥ CTCAE Grade III: 44.3 % vs. 39.6 %), haemorrhage or thromboembolism (≥ CTCAE Grade II: 2.1 % vs. 4.0 %), and neurotoxicity (≥ CTCAE Grade III: 4.1 % vs. 5.9 %) were observed in comparable frequencies in both groups (Spectrila versus reference).
Maltese: 39.6%), emorraġija jew tromboemboliżmu (≥ CTCAE Grad II: 2.1% vs. 4.0%), u newrotossiċità (≥ CTCAE Grade III: 4.1% vs. 5.9%) ġew osservati fi frekwenzi komparabbli fiż-żewġ gruppi (Spectrila kontra r-referenza).
English: Haemorrhagic pancreatitis, necrotising pancreatitis, parotitis Very rare
Maltese: Pankreatite emorraġika, pankreatite nekrotizzanti, parotite Rari ħafna
English: • severe inflammation of the pancreas (acute pancreatitis),
Maltese: • infjammazzjoni severa tal-frixa (pankreatite akuta),
English: Hypersensitivity including bronchospasm Rare
Maltese: Sensittività eċċessiva li tinkludi bronkospażmu
English: One unit (U) is defined as the quantity of enzyme required to liberate one µmol ammonia per minute at pH 7.3 and 37°C.
Maltese: Unità waħda (U) hi definita bħala l-kwantità ta' enzima meħtieġa biex tillibera μmol wieħed ta' ammonia kull minuta f'pH 7.3 u temperatura ta' 37°C.
English: There have been isolated reports of fatal outcomes.
Maltese: Kien hemm rapporti iżolati ta' riżultati fatali.
English: Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL).
Maltese: Il-parametri farmakokinetiċi wara l-għoti ta' 5,000 U/m² ta' Spectrila ġew stabbiliti f'14-il tifel/tifla/adolexxent (età ta' 2 - 14-il sena) b'de novo ALL (studju MC-ASP.4/ALL).
English: Storage would normally not be longer than 24 hours at 2 °C - 8 °C.
Maltese: Il-ħażna normalment ma tkunx itwal minn 24 siegħa f'temperatura ta' 2°C - 8°C.
English: Study in infants with de novo ALL
Maltese: Studju fi trabi b'de novo ALL
English: • severe liver function abnormalities (determined by laboratory tests),
Maltese: • anormalitajiet severi fir-riżultati tal-funzjoni tal-fwied (stabbiliti permezz ta' testijiet tal laboratorju),