FrancophonIA/ELRC3.0 huggingface dataset:
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase eliglustat exposure approximately up to 3-fold.
Maltese: B'dożaġġ ta' 84 mg darbtejn kuljum ta' eliglustat f'pazjenti li mhumiex PMs, huwa previst li l-użu flistess ħin ta' inibituri moderati ta' CYP3A (eż. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) jżid l-espożizzjoni għal eliglustat sa madwar 3 darbiet.
English: In this trial with demonstrated ability to detect small effects, the upper bound of the onesided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTcF was below 10 msec, the threshold for regulatory concern.
Maltese: F'din il-prova b'kapaċità ppruvata li tiskopri effetti żgħar, l-ogħla limitu tal-intervall ta' fiduċja ta' 95% b'naħa waħda għall-akbar QTcF aġġustat bi plaċebo u kkoreġut fil-linja bażi kien taħt l-10 msec, il-limitu għal tħassib regolatorju.
English: Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.
Maltese: Wara dożi ripetuti ta' eliglustat 84 mg darbtejn kuljum f'dawk li mhumiex PMs u darba kuljum f'dawk li huma PMs, l-istat stabbli ntlaħaq wara 4 ijiem, bi proporzjon ta' akkumulazzjoni ta' 3 darbiet jew inqas.
English: • Heartburn (dyspepsia)
Maltese: • Għeja (debbulizza))
English: Table 5: Changes from Month 12 (primary analysis period) to Month 48 in patients with GD1 in the Long Term Treatment Period on Cerdelga in study 02607
Maltese: Bidliet minn Xahar 12 (perjodu tal-analiżi primarja) sa Xahar 48 f'pazjenti b'GD1 fil-Perjodu ta' Trattament fit-Tul b'Cerdelga fl-istudju 02607
English: Haemoglobin Level Patients with stable haemoglobin level (%) Change from baseline in Haemoglobin Level (g/dL) Liver Volume Patients with stable liver volume (%)
Maltese: Volum tal-Milsa MN (%) (endpoint primarju) Bidla assoluta fil-Livell talEmoglobina (g/dL) (endpoint sekondarju)
English: Safety margins for the chronic rat and dog studies ranged between 8-fold and 15-fold using total plasma exposure and 1to 2-fold using unbound (free fraction) plasma exposures.
Maltese: Il-marġini tas-sigurtà għall-istudji kroniċi fuq il-firien u l-klieb kienu jvarjaw bejn 8 darbiet u 15-il darba bl-użu tal-espożizzjoni totali fil-plasma u ta' darba sa darbtejn bl-użu ta' espożizzjoni mingħajr irbit (frazzjoni ħielsa) fil-plasma.
English: Agents that may decrease eliglustat exposure
Maltese: Sustanzi li jistgħu jżidu l-espożizzjoni għal eliglustat
English: • goldenseal - (also known as Hydrastis canadensis) a herbal preparation obtained without a prescription, used as a digestive aid.
Maltese: • goldenseal - (magħrufa wkoll bħala Hydrastis canadensis) preparazzjoni magħmula mill ħxejjex miksuba mingħajr riċetta ta' tabib, użata bħala għajnuna fid-diġestjoni.
English: The use of strong CYP3A inhibitors is contraindicated in PMs.
Maltese: L-użu ta' inibituri qawwijin ta' CYP3A huwa kontraindikat f'PMs.
English: Caution should be used with moderate CYP3A inhibitors in IMs and EMs.
Maltese: Għandha tintuża l-kawtela b'inibituri moderati ta' CYP3A f'IMs u EMs.
English: After repeated 84 mg twice daily doses of eliglustat in PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin resulted in an approximately 95% decrease in eliglustat exposure.
Maltese: 600 mg ta' rifampicin darba kuljum wassal għal tnaqqis ta' madwar 95 % fl-espożizzjoni ta' eliglustat.
English: Platelet Count (x109/L)
Maltese: Għadd tal-Plejtlits (x109/L) 16 67.53
English: • aprepitant - antiemetic (used to reduce vomiting)
Maltese: • aprepitant - antiemetiċi (użati biex inaqqsu r-rimettar)
English: In these four studies a total of 393 patients between the ages of 16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years).
Maltese: 393 pazjent b'etajiet bejn 16-75 sena rċevew eliglustat għal tul medjan ta' 3.5 snin ( sa 9.3 snin).
English: Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients.
Maltese: L-istudju 304 kien studju multiċentriku, b'fergħa unika u b'tikketta mikxufa ta' Cerdelga fuq 26 pazjent.
English: Caution should be used with moderate CYP2D6 inhibitors in IMs and EMs.
Maltese: Għandha tintuża kawtela b'inibituri moderati ta' CYP2D6 f'IMs u EMs.
English: Capsule with pearl blue-green opaque cap and pearl white opaque body with “GZ02” printed in black on the body of the capsule.
Maltese: Kapsula b'kappa opaka kaħlanija ħadra perla u b'parti ewlenija opaka bajda perla b'“GZ02” stampata bl-iswed fuq il-parti ewlenija tal-kapsula.
English: • Vomiting
Maltese: • Sturdament
English: SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations.
Maltese: L-SRT għandha l-għan li tnaqqas irrata tas-sintesi tas-substrat maġġuri glucosylceramide (GL-1) biex tagħmel tajjeb għar-rata indebolita tagħha ta' kataboliżmu f'pazjenti b'GD1, biex b'hekk tiġi evitata l-akkumulazzjoni ta' glucosylceramide u jittaffew il-manifestazzjonijiet kliniċi.
English: • dabigatran - anticoagulant (used to thin the blood)
Maltese: • dabigatran - antikoagulant (użat biex iraqqaq id-demm)
English: There are no known effects on fertility at normal doses.
Maltese: Ma hemm ebda effett magħruf fuq il-fertilità f'dożi normali.
English: Population pharmacokinetic analysis shows that the CYP2D6 predicted phenotype based on genotype is the most important factor affecting pharmacokinetic variability.
Maltese: Analiżi farmakokinetika tal-popolazzjoni turi li t-tbassir tal-fenotip ta' CYP2D6 abbażi talġenotip huwa l-aktar fattur importanti li jaffettwa l-varjabilità farmakokinetika.
English: • Stomach ache (upper abdominal pain)
Maltese: • Nefħa fl-addome (distensjoni addominali)
English: Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism.
Maltese: Iż-żmien medjan biex jintlaħqu konċentrazzjonijiet massimi fil-plasma jseħħ bejn 1.5 sa 6 sigħat wara l-għoti tad-doża, b'bijodisponibilità orali baxxa (<5%) minħabba metaboliżmu first-pass sinifikanti.
English: A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor (e.g. paroxetine, fluoxetine, quinidine, bupropion) is used concomitantly in IMs and EMs.
Maltese: għandha tiġi kkunsidrata doża ta' eliglustat ta' 84 mg darba kuljum meta fl-istess ħin jintuża inibitur qawwi ta' CYP2D6 (eż. paroxetine, fluoxetine, quinidine, bupropion).
English: Table 2: Change from baseline to Month 9 (primary analysis period) in treatment-naïve patients with GD1 receiving treatment with Cerdelga in study 02507
Maltese: Tabella 2: Bidla mil-linja bażi sa Xahar 9 (perjodu tal-analiżi primarja) f'pazjenti b'GD1 li qatt ma rċevew kura qabel u li qed jirċievu l-kura b'Cerdelga fl-istudju 02507
English: Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in patients with cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, and in combination with Class IA (e.g. quinidine) and Class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Maltese: Minħabba li f'konċentrazzjonijiet sostanzjalment elevati fil-plasma eliglustat huwa previst li jikkawża żidiet ħfief fl-intervalli tal-ECG, l-użu ta' eliglustat għandu jiġi evitat f'pazjenti b'mard tal qalb (insuffiċjenza konġestiva tal-qalb, infart mijokardijaku akut riċenti, bradikardja, imblokk tal-qalb,
English: - If you are an intermediate or extensive metaboliser and use medicines known as strong or moderate CYP2D6 inhibitors (examples are quinidine and terbinafine) used in combination with strong or moderate CYP3A inhibitors (examples are erythromycin and itraconazole).
Maltese: - Jekk inti metabolizzatur intermedju jew estensiv u tuża mediċini magħrufin bħala inibituri b'saħħithom jew moderati ta' CYP2D6 (eżempji huma quinidine u terbinafine) użati flimkien ma' inibituri b'saħħithom jew moderati ta' CYP3A (eżempji huma erythromycin u itraconazole).
English: o Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status.
Maltese: Jistgħu jkunu meħtieġa dożi aktar baxxi ta' prodotti mediċinali li huma substrati ta' CYP2D6.
English: Other medicines and Cerdelga
Maltese: Mediċini oħra u Cerdelga
English: The principal target organs for eliglustat in toxicology studies are the GI tract, lymphoid organs, the liver in rat only and, in the male rat only, the reproductive system.
Maltese: Fi studji tossikoloġiċi, l-organi prinċipali l-aktar milquta minn eliglustat huma l-passaġġ gastrointestinali, l-organi limfatiċi, il-fwied fil-firien biss u fil-firien irġiel biss, is-sistema riproduttiva.
English: Placental transfer of eliglustat and its metabolites was shown in the rat.
Maltese: Fil-firien deher trasferiment plaċentali ta' eliglustat u tal-metaboliti tiegħu.
English: If you are an intermediate metaboliser or extensive metaboliser:
Maltese: Jekk inti metabolizzatur intermedju jew metabolizzatur estensiv:
English: Exposures in the carcinogenicity studies were approximately 4-fold and 3-fold greater in mice and rats, respectively, than the mean predicted human eliglustat total plasma exposure, or less than 1-fold using unbound plasma exposure.
Maltese: Fl istudji karċinoġenetiċi, l-espożizzjonijiet kienu madwar 4 darbiet u 3 darbiet ogħla fil-ġrieden u lfirien, rispettivament, mill-medja tal-espożizzjoni totali prevista ta' eliglustat fil-plasma tal-bniedem, jew anqas minn darba bl-użu ta' espożizzjoni fil-plasma mingħajr irbit.
English: In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).
Maltese: Eliglustat huwa kontra-indikat f'metabolizzaturi estensivi ta' CYP2D6 (EMs) b'indeboliment talfwied sever (Child-Pugh klassi Ċ) (ara sezzjonijiet 4.3 u 5.2).
English: Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status (see section 4.2, Special populations).
Maltese: Qabel tinbeda l-kura b'Cerdelga, il-pazjenti għandhom jiġu evalwati għall-ġenotip ta' CYP2D6 biex jiġi ddeterminat l-istat metabolizzatur ta' CYP2D6 (ara sezzjoni 4.2, Popolazzjonijiet speċjali).
English: In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.
Maltese: F'metabolizzaturi estensivi (EMs) b'indeboliment ħafif tal-fwied: ara sezzjonijiet 4.2, u 4.4.
English: Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor (see section 4.3).
Maltese: Cerdelga huwa kontraindikat f'pazjenti li huma metabolizzaturi intermedji (IMs) jew metabolizzaturi estensivi (EMs) ta' CYP2D6 u li fl-istess ħin jkunu qed jieħdu inibitur qawwi jew moderat ta' CYP2D6 u inibitur qawwi jew moderat ta' CYP3A u f'pazjenti li huma metabolizzaturi dgħajfa (PMs)
English: Medicines that may decrease the level of Cerdelga in the blood:
Maltese: Mediċini li jistgħu jnaqqsu l-livell ta' Cerdelga fid-demm:
English: Some treatment-naïve patients showed less than 20% spleen volume reduction (sub-optimal results) after 9 months of treatment (see section 5.1).
Maltese: Xi pazjenti li qatt ma' ħadu kura qabel urew inqas minn 20 % tnaqqis fil-volum tal-milsa (riżultati li mhumiex mill-aħjar) wara 9 xhur ta' kura (ara sezzjoni 5.1).
English: • St. John's wort - (also known as Hypericum perforatum) a herbal preparation obtained without a prescription, used to treat depression and other conditions
Maltese: John's wort - (magħrufa wkoll bħala Hypericum perforatum) preparazzjoni magħmula mill ħxejjex miksuba mingħajr riċetta ta' tabib, użata biex tikkura d-depressjoni u kondizzjonijiet oħrajn
English: • Difficulty swallowing (dysphagia)
Maltese: • Diffikultà biex tibla' (disfaġja)
English: Due to significantly increased eliglustat plasma concentrations, Cerdelga is contraindicated in CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor (see sections 4.2 and 5.2).
Maltese: Minħabba żieda sinifikanti fil-konċentrazzjoni ta' eliglustat fil-plażma , Cerdelga huwa kontra-indikat f'metabolizzaturi estensivi ta' CYP2D6 (EMs) b'indeboliment tal-fwied moderat jew sever u f'metabolizzaturi estensivi ta' CYP2D6 (EMs) b'indeboliment ħafif tal-fwied li qed jieħdu inibitur qawwi jew moderat ta' CYP2D6 (ara sezzjonijiet 4.2 u 5.2).
English: The predicted exposures with 84 mg eliglustat once daily in patients who are PMs are expected to be similar to exposures observed with 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs).
Maltese: L-espożizzjonijiet previsti b'84 mg eliglustat darba kuljum f'pazjenti li huma PMs huma mistennija li jkunu simili għall-espożizzjonijiet osservati b'84 mg eliglustat darbtejn kuljum f'metabolizzaturi intermedji (IMs) ta' CYP2D6.
English: • Joint pain (arthalagia)
Maltese: • Uġigħ fil-ġogi (artralġja)
English: Limited or no data are available in CYP2D6 extensive metabolisers (EMs), intermediate metabolisers (IMs) or poor metabolisers (PMs) with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate, or severe renal impairment; use of eliglustat in these patients is not recommended (see sections 4.2 and 5.2).
Maltese: f'metabolizzaturi intermedji (IMs) jew f'metabolizzaturi dgħajfa (PMs) ta' CYP2D6, b'ESRD u f'metabolizzaturi intermedji (IMs) jew f'metabolizzaturi dgħajfa (PMs) ta' CYP2D6 b'indeboliment tal-kliewi ħafif, moderat jew sever; l-użu ta' Cerdelga f'dawn il-pazjenti mhuwiex irrakkomandat (ara sezzjonijiet 4.2 u 5.2).
English: Throat irritation
Maltese: Irritazzjoni fil-gerżuma
English: All PMs received 42 mg eliglustat twice daily, and four of these (80%) had an adequate clinical response.
Maltese: Il-PMs kollha rċevew 42 mg ta' eliglustat darbtejn kuljum u erbgħa minn dawn (80 %) kellhom rispons kliniku adegwat.
English: Patients with pre-existing cardiac conditions
Maltese: Pazjenti b'kondizzjonijiet kardijaċi pre-eżistenti
English: Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or no impact on the pharmacokinetics of eliglustat.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, is-sess, il-piż tal-ġisem, l-età, u r-razza ma kellhom l-ebda effett jew ftit li xejn kellhom effett fuq il-farmakokinetika ta' eliglustat.
English: After 9 months of treatment, in Study 02507, bone marrow infiltration by Gaucher cells, as determined by the total Bone Marrow Burden (BMB) score (assessed by MRI in lumbar spine and femur) decreased by a mean of 1.1 points in Cerdelga treated patients (n=19) compared to no change in patients receiving placebo (n=20).
Maltese: Wara 9 xhur ta' trattament , fl-istudju 02507, l-infiltrazzjoni taċ-ċelluli Gaucher fil-mudullun, ikkalkulat permezz tal-punteġġ totali tal-Piż fuq il-Mudullun (Bone Marrow Burden, BMB) (evalwat permezz ta' MRI fl-ispina lumbari u l-wirk) naqset b'medja ta' 1.1 punti f'pazjenti ttrattati b'Cerdelga
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat mg once daily should be considered (see sections 4.2 and 5.2).
Maltese: F'metabolizzaturi intermedji (IMs) jew metabolizzaturi dgħajfa (PMs) ta' CYP2D6 b'indeboliment tal-kliewi ħafif, moderat jew sever jew ESRD, eliglustat mhuwiex irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: During the open-label long term treatment period with Cerdelga (extension phase) the percentage of patients with complete data meeting the composite stability endpoint was maintained at 84.6% (n=136) after 2 years, 84.4% (n=109) after 3 years and 91.1% (n=45) after 4 years.
Maltese: Matul il-perjodu open label ta' trattament fit-tul b'Cerdelga (fażi ta' estensjoni) l-perċentwal ta' pazjenti b'tagħrif komplet u li ssodisfaw l-endpoint kompost ta' stabbiltà nżamm f'84.64% (n=136) wara sentejn, 84.
English: In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).
Maltese: F'metabolizzaturi estensivi ta' CYP2D6 b'mard tal-kliewi fl-aħħar stadju (ESRD), eliglustat mhuwiex irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and
Maltese: F'metabolizzaturi estensivi (EMs) b'indeboliment moderat jew sever tal-fwied: ara sezzjonijiet 4.2 u
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, eliglustat is not recommended (see sections 4.4 and 5.2).
Maltese: F'metabolizzaturi intermedji (IMs) jew metabolizzaturi dgħajfa (PMs) ta' CYP2D6 b'kwalunkwe tip ta' indeboliment tal-fwied, eliglustat mhux irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: Use of eliglustat in these patients is not recommended (see sections 4.2 and 5.2).
Maltese: L-użu ta' eliglustat f'dawn il-pazjenti mhux irrakkomandat (ara sezzjonijiet 4.2 u 5.2).
English: The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).
Maltese: Id-doża rrakkomandata hija 84 mg eliglustat darba kuljum f'metabolizzaturi dgħajfa (PMs) ta' CYP2D6.
English: Agents that may increase eliglustat exposure
Maltese: Sustanzi li jistgħu jnaqqsu l-espożizzjoni għal eliglustat
English: Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.
Maltese: Evita l-konsum ta' grejpfrut jew ta' meraq tal-grejpfrut minħabba li jista' jżid il-livell ta' Cerdelga f'demmek.
English: - If you are a poor metaboliser and use medicines known as strong CYP3A inhibitors (for example itraconazole).
Maltese: - Jekk metabolizzatur dgħajjef u tuża mediċini magħrufin bħala inibituri b'saħħithom ta' CYP3A (per eżempju itraconazole).
English: While there was no apparent effect on heart rate, concentration-related increases were observed for the placebo corrected change from baseline in the PR, QRS, and QTc intervals.
Maltese: Filwaqt li ma kien hemm l-ebda effett apparenti fuq ir-rata tal-qalb, kienu osservati żidiet relatati mal konċentrazzjoni għall-bidla kkoreġuta bil-plaċebo mil-linja bażi fl-intervalli tal-PR, QRS, u l-QTc.
English: Cerdelga capsules have a pearl blue-green opaque cap and a pearl white opaque body with “GZ02” printed in black on the capsule.
Maltese: Il-kapsuli ta' Cerdelga għandhom kappa opaka kaħlanija ħadra perla u bil-parti ewlenija opaka bajda perla b'“GZ02” stampata bl-iswed fuq il-kapsula.
English: Information for the patient:
Maltese: Appel depuis l'étranger:
English: o This patient is using eliglustat (Cerdelga) for the treatment of Gaucher Disease type 1.
Maltese: “Mediċini oħra u Cerdelga”għal lista estiża ta' mediċini).
English: At maternal toxic doses in rats, foetuses showed a higher incidence of dilated cerebral ventricles, abnormal number of ribs or lumbar vertebrae, and many bones showed poor ossification.
Maltese: In-nies huma differenti mil-lat tal-veloċità li biha ġisimhom ikisser din il-mediċina.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cerdelga in the subsets of the paediatric population from 24 months to less than 18 years in Gaucher disease Type 1 and Type 3 (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Cerdelga fis-settijiet tal-popolazzjoni pedjatrika min 24 xahar sa anqas minn 18-il sena fil-marda ta' Gaucher tat-Tip 1 u Tip 3 (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors.
Maltese: L-inibituri ta' CYP2D6 użati fl-istess ħin ma' inibituri ta' CYP3A
English: Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations (see section 4.4 and 4.5).
Maltese: Taħt dawn il-kondizzjonijiet, l-użu ta' Cerdelga jwassal għal konċentrazzjonijiet sostanzjalment elevati ta' eliglustat fil-plasma (ara sezzjoni 4.4 u 4.5).
English: After repeated 84 mg twice daily doses of Cerdelga, Cmax and AUC0-12 are predicted to be 2.4- and 2.9fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment and 6.4- and 8.9fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Maltese: 6.4- u 8.9-darbiet ogħla f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment epatiku moderat meta mqabbla ma' metabolizzaturi estensivi (EMs) ta' CYP2D6 b'saħħithom.
English: • are an end stage renal disease (ESRD) patient.
Maltese: • pazjent fl-aħħar stadju ta' mard tal-kliewi (ESRD- end stage renal disease) Tfal u adolexxenti
English: System Organ Class (SOC, MedDRA)
Maltese: Klassi tasSistemi u talOrgani (SOC, MedDRA)
English: ADRs (MedDRA Preferred Term, PT)
Maltese: ADRs (Terminu ppreferut ta' MedDRA, PT)
English: Human normal immunoglobulin 200 mg IgG .......................................... ≥ 98% IgA .......................... ≤ 50 micrograms
Maltese: Immunoglobulina normali umana 200 mg IgG ............................................ ≥ 98% IgA ........................ ≤ 50 mikrogramma
English: Absorption and Distribution
Maltese: Assorbiment u Distribuzzjoni
English: (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
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).
English: Embolic and thrombotic events
Maltese: Avvenimenti emboliċi u trombotiċi
English: Direct comparative data for Hizentra versus IVIG are not available.
Maltese: Data kumparattiva għal Hizentra versus IVIG mhijiex disponibbli.
English: Pruritus, Urticaria
Maltese: Ħakk, Urtikarja
English: • The active substance is human normal immunoglobulin.
Maltese: • Is-sustanza attiva hi immunoglobulina normali umana.
English: Infusion parameter and responder rate (%)
Maltese: Parametru ta' infużjoni u rata ta' dawk li rrispondew (%)
English: Hizentra has an approximate osmolality of 380 mOsmol/kg.
Maltese: Hizentra għandu osmolalità ta' madwar 380 mOsmol/kg.
English: The maximum IgA content is 50 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA hu ta' 50 mikrogramma/ml.
English: 3. pump-assisted volumes
Maltese: 3. volumi bil-pompa
English: Immunomodulatory therapy
Maltese: Terapija immunomodulatorja
English: Human normal immunoglobulin (SCIg)
Maltese: Immunoglobulina normali umana (SCIg)
English: Kaplan-Meier Plot Time to CIDP Relapse
Maltese: Plot Kaplan-Meier Żmien għar-Rikaduta ta' CIDP
English: Excipients with known effects Hizentra contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Maltese: Hizentra fih madwar 250 mmol/L (firxa: 210 sa 290) ta' L-proline.
English: Tremor (including Psychomotor hyperactivity)
Maltese: Rogħda (inkluża attività Psikomotorja eċċessiva)
English: CSL Behring AG Wankdorfstrasse 10 CH-3000 Bern 22 Switzerland
Maltese: CSL Behring AG Wankdorfstrasse 10, CH-3000
English: In case of shock, standard medical treatment should be administered.
Maltese: F'każ ta' xokk, għandu jingħata trattament mediku standard.
English: Hizentra contains proline
Maltese: Hizentra fih proline