FrancophonIA/ELRC3.0 huggingface dataset:
English: 60 ampoules (10x6)
Maltese: 60 ampulla (10x6)
English: Pasireotide is a cyclohexapeptide, injectable somatostatin analogue.
Maltese: Pasireotide hu cyclohexapeptide, analogu ta' somatostatin injettabbli.
English: Active control N=68 n (%)
Maltese: N=68 n (%)
English: Table 3 Key results at week 24 (Study C2402)
Maltese: Tabella 3 Riżultati ewlenin f'ġimgħa 24 (Studju C2402)
English: 51.6% p=0.536 * Primary endpoint (patients with IGF-1 <lower limit of normal (LLN) were not considered “responders”).
Maltese: 51.6% p=0.536 * Endpoint primarju (pazjenti b'IGF-1< mil-limitu l-aktar baxx tan-normal (LLN) ma tqisux bħala “dawk li rrispondew”).
English: 30 ampoules (5x6)
Maltese: 30 ampulla (5x6)
English: IGF-1 mean values at baseline were 2.6, 2.8 and 2.9 x ULN, respectively.
Maltese: Il-valuri tal-medja ta' IGF-1 fil-linja bażi kienu ta' 2.6, 2.8 u 2.9 x ULN, rispettivament.
English: (figure B).
Maltese: NUMRU(I)
English: Compound hsst1
Maltese: Kompost hsst1
English: * Cholecystitis includes cholecystitis acute
Maltese: * Il-Koleċistite tinkludi koleċistite akuta
English: In subjects with moderate and severe hepatic impairment, AUCinf was increased 60% and 79%, Cmax was increased 67% and 69%, and CL/F was decreased 37% and 44%, respectively.
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat u gravi, l-AUCinf żdied b'60% u b'79%, is-Cmax żdied b'67% u 69%, u s-CL/F naqas b'37% u b'44%, rispettivament.
English: Pasireotide intramuscular use n (%) N=176
Maltese: Pasireotide użu għal ġol-muskoli n (%) N=176
English: 18 ampoules (3x6)
Maltese: 18-il ampulla (3x6)
English: Alopecia, pruritus
Maltese: Alopeċja, ħakk
English: The unbound plasma pasireotide exposure (AUCinf,u) was increased in subjects with renal impairment (mild: 33%; moderate: 25%, severe: 99%, ESRD: 143%) compared to control subjects.
Maltese: 33%; moderata: 25%; qawwija: 99%, ESRD: 143%) imqabbla massuġġetti kkontrollati.
English: procainamide, quinidine, sotalol, dofetilide, ibutilide, amiodarone or dronedarone; - medicines to treat bacterial infections (by mouth: clarithromycin, moxifloxacin; via injection:
Maltese: procainamide, quinidine, sotalol, dofetilide, ibutilide, amiodarone jew dronedarone; - mediċini li jittrattaw infezzjonijiet batteriċi (bil-ħalq: clarithromycin, moxifloxacin; b'injezzjoni:
English: Step 8
Maltese: Stadju 8
English: Tartaric acid Sodium hydroxide Water for injections
Maltese: Tartaric acid Sodium hydroxide Ilma għall-injezzjonijiet
English: • cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
Maltese: • impedituri ta' cholinesterase (rivastigmine, physostigmine); - mediċini li jikkontrollaw il-bilanċ tal-elettroliti (potassju, manjeżju) f'ġismek.
English: GH<2.5 μg/l and normalised IGF-1*
Maltese: GH <2.5 μg/l u IGF-1 normalizzat*
English: Solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Maltese: Solvent: carmellose sodium, mannitol, poloxamer 188, ilma għall-injezzjonijiet.
English: Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
Maltese: Kienu rrappurtati reazzjonijiet mhux mixtieqa fi Grad 1 u 2 f'57.4% tal-pazjenti.
English: Improvements were observed in both dose groups for CushingQoL and the Mental Component Summary (MCS) of SF-12v2, but not for the Physical Component Summary (PCS) of SF-12v2.
Maltese: Ġie osservat titjib fiż-żewġ gruppi ta' dożi għal CushingQoL u s-Sommarju tal-Komponent Mentali (MCS) ta' SF-12v2, iżda mhux għas-Sommarju tal-Komponent Fiżiku (PCS) ta' SF-12v2.
English: Most patients (82.0%) had undergone prior pituitary surgery, and the mean baseline mUFC was 470 nmol/24h (ULN: 166.5 nmol/24h).
Maltese: Bosta pazjenti (82.0%) kienu għamlu operazzjoni pitwitarja, u l-medja tal-mUFC fil-linja bażi kienet ta' 470 nmol/24h (ULN: 166.5 nmol/24h).
English: Baseline mean GH was 17.6 µg/l, 12.1 µg/l and 9.5 µg/l, in the 40 mg, 60 mg and active control groups, respectively.
Maltese: Il-medja ta' GH fil-linja bażi kienet ta' 17.6 µg/l, 12.1 µg/l u 9.5 µg/l, fil-gruppi mogħtija 40 mg, 60 mg u l-grupp ikkontrollat blattiv, rispettivament.
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Maltese: F'livelli ta' dożi terapewtiċi pasireotide mhuwiex inibitur ta' UGT1A1, OATP, 1B1 jew 1B3, P-gp, BCRP, MRP2, u BSEP.
English: Acromegaly
Maltese: Akromegalija
English: Sinus bradycardia includes bradycardia and sinus bradycardia.
Maltese: ** Bradikardija tas-sinus tinkludi bradikardija u bradikardija tas-sinus.
English: Results are the meanSEM of IC50 values expressed as nmol/l.
Maltese: Ir-riżultati huma l-valuri tal-medjaSEM ta' IC50 espressi bħala nmol/l.
English: Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Maltese: Ilkoleċistite tinkludi koleċistite akuta u koliċistite kronika.
English: Step 8:
Maltese: Stadju 8:
English: Based on in vitro data pasireotide is not a substrate of the efflux transporter BCRP (breast cancer resistance protein) nor of the influx transporters OCT1 (organic cation transporter 1), OATP (organic anion-transporting polypeptide) 1B1, 1B3 or 2B1.
Maltese: Skont tagħrif in vitro pasireotide mhuwiex sottstrat tat-trasportatur tal-effluss BCRP (proteina li tirreżisti l-kanċer tas-sider) u lanqas tat-trasportaturi tal-influss OCT1 (trasportatur organiku kazzjoni 1), OATP (polipeptide trasportatur organiku anjoni) 1B1, 1B3 jew 2B1.
English: Gastrointestinal disorders were frequently reported with Signifor.
Maltese: Id-disturbi gastrointestinali kienu spiss irrappurtati b'Signifor.
English: Elderly patients (≥65 years) Age is not a significant covariate in the population pharmacokinetic analysis of patients.
Maltese: Pazjenti adulti (≥65 sena) L-età mhijiex kovarjant qawwi fl-analiżi farmakokinetika tal-popolazzjoni f'pazjenti.
English: - In the solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Maltese: - Fis-solvent: carmellose sodium, mannitol, poloxamer 188, ilma għall-injezzjonijiet.
English: Step 5:
Maltese: Stadju 5:
English: Bradycardia has been reported with the use of pasireotide (see section 4.8).
Maltese: Kienet irrappurtata bradikardija bl-użu ta' pasireotide (ara sezzjoni 4.8).
English: GH<2.5 μg/l * Primary endpoint (patients with IGF-1< lower limit of normal (LLN) were not considered “responders”).
Maltese: GH<2.5 μg/l * Endpoint primarju (pazjenti b'IGF-1 < mil-limitu l-aktar baxx tan-normal (LLN) ma tqisux bħala “dawk li rrispondew”).
English: Other side effects of Signifor may include:
Maltese: Effetti sekondarji oħra ta' Signifor jistgħu jinkludu:
English: - Extreme tiredness.
Maltese: - Ġebla fil-marrara.
English: In clinical studies in Cushing's disease patients, QTcF of >500 msec was observed in two out of 201 patients.
Maltese: Fi studji kliniċi fost pazjenti morda bil-marda ta' Cushing, kien osservat QTcF ta' >500 msek f'żewġ pazjenti minn 201.
English: Mean HbA1c increases were less pronounced in patients with normal glycaemia (n=62 overall) at study entry (i.e. 5.29% and 5.22% at baseline and 6.50% and 6.75% at month 6 for the 0.6 and 0.9 mg twice daily dose groups, respectively) relative to pre-diabetic patients (i.e. n=38 overall; 5.77% and 5.71% at baseline and 7.45% and 7.13% at month 6) or diabetic patients (i.e. n=54 overall; 6.50% and 6.42% at baseline and 7.95% and 8.30% at month 6).
Maltese: Żidiet fil-medja talHbA1c dehru b'anqas qawwa f'pazjenti bi gliċemija normali (n=62 b'kollox) fil-bidu tal-istudju (i.e. 5.29% u 5.22% fil-linja bażi u 6.50% u 6.75% fis-6 xahar għall-gruppi mogħtija doża ta' 0.6 u 0.9 mg darbtejn kuljum, rispettivament) relattivi għall-pazjenti li diġà kellhom id-dijabete (i.e. n=38 b'kollox; 5.77% u 5.71% fil-linja bażi u 7.45% u 7.13% fis-6 xahar) jew pazjenti bid-dijabete (i.e. n=54 b'kollox; 6.50% u 6.42% fil-linja bażi u 7.95% u 8.30% fis-6 xahar).
English: Decreased appetite, type 2 diabetes mellitus, glucose tolerance impaired
Maltese: Tnaqqis fl-aptit, dijabete mellitus tattip 2, indeboliment tattolleranza għallglukosju
English: At month 6, normalisation of mean UFC levels was observed in 14.6% (95% CI 7.0-22.3) and 26.3% (95% CI 16.6-35.9) of patients randomised to pasireotide 0.6 mg and 0.9 mg twice daily, respectively.
Maltese: Fis-6 xahar, in-normalizzazzjoni tal-medja tal-livelli tal-UFC dehret f'14.6% (95% CI 7.0-22.3) u f'26.3% (95% CI 16.6-35.9) tal-pazjenti biex jieħdu 0.6 mg u 0.9 mg pasireotide darbtejn kuljum b'mod randomizzat, rispettivament.
English: Powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
Maltese: Trab: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
English: At month 25, 48.6% of patients (36/74) in the pasireotide intramuscular use group and 45.7% (21/46) in the octreotide intramuscular use group achieved biochemical control.
Maltese: Fil-25 xahar, 48.6% tal-pazjenti (36/74) fil-grupp mogħti pasireotide użu għal ġol-muskoli u 45.7% (21/46) fil-grupp mogħti octreotide użu għal ġol-muskoli kisbu kontroll bijokimiku.
English: Step 5
Maltese: Stadju 5
English: The apparent clearance (CL/F) of pasireotide intramuscular use in healthy volunteers is on average 4.5-8.5 litres/h.
Maltese: It-tneħħija apparenti (CL/F) ta' pasireotide użu għal ġol-muskoli f'voluntiera b'saħħithom hi medjament ta' 4.5-8.5 litri/h.
English: Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also section 4.4).
Maltese: Pasireotide għandu jintuża b'għaqal f'pazjenti li qed jingħataw fl-istess ħin prodotti mediċinali li jtawlu l-intervall tal-QT, bħalma huma l-antiarritmiċi ta' klassi Ia (eż. quinidine, procainamide, disopyramide), antiarritmiċi ta' klassi III (eż. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), ċerti antibatteriċi (erythromycin fil-vini, injezzjoni b'pentamidine, clarithromycin, moxifloxacin), ċerti antipsikotiċi (eż. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), ċerti antiistamini (eż. terfenadine, astemizole, mizolastine), antimalarjali (eż. chloroquine, halofantrine, lumefantrine), ċerti antifungali (ketoconazole, ħlief fixxampù) (ara wkoll sezzjoni 4.4).
English: Step 1:
Maltese: Stadju 1:
English: GH <2.5 μg/l and IGF-1 ≤ULN Normalised IGF-1
Maltese: GH <2.5 μg/l u IGF-1 ≤ULN
English: Hyperglycaemia, diabetes mellitus
Maltese: Ipergliċemija, dijabete mellitus
English: Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Maltese: Il-pakketti fihom 6 ampulli jew pakketti b'ħafna li fihom 18 (3 x 6), 30 (5 x 6) jew 60 (10 x 6) ampulli.
English: Percentage of patients with: mUFC ≤ULN at Month 7 (95% CI) * mUFC ≤ULN and no prior dose increase at Month 7 (95% CI) mUFC ≤ULN or ≥50% decrease from baseline at month 7 (95% CI) Median (min, max) % mUFC change from baseline at month 7 Median (min, max) % mUFC change from baseline at month 12 * Primary endpoint using LOCF (last observation carried forward) mUFC: mean urinary free cortisol; ULN: upper limit of normal; CI: confidence interval
Maltese: Perċentwal ta' pazjenti bi: mUFC ≤ULN fis-7 Xahar (95% CI) * mUFC ≤ULN u l-ebda żieda fid-doża minn qabel fis-7 Xahar (95% CI) mUFC ≤ULN jew ≥50% tnaqqis mil-linja bażi fis-7 xahar (95% CI) Il-medjan (min, max) % tal-bidla fl-mUFC millinja bażi fis-7 xahar Il-medjan (min, max) % tal-bidla fl-mUFC millinja bażi fit-12-il xahar * End point primarju permezz ta' LOCF (l-aħħar osservazzjoni mgħoddija 'l quddiem) mUFC: medja tal-kortisol medju urinarju;
English: In a pooled analysis of the two pivotal studies, the overall incidence of hyperglycaemia-related adverse reactions was 58.6% (all grades) and 9.9% (CTC Grade 3 and 4) for Signifor intramuscular use versus 18.0% (all grades) and 1.1% (CTC Grade 3 and 4) for the active control.
Maltese: Skont analiżi miġmugħa taż-żewġ studji pivotali, l-inċidenza sħiħa ta' reazzjonijiet avversi b'rabta ma' ipergliċemija kienu 58.6% (il-gradi kollha) u 9.9% (CTC Grad 3 u 4) għal Signifor intramuskolari kontra 18.0% (il-gradi kollha) u 1.1% (CTC Grad 3 u 4) għall-kontroll attiv.
English: The recommended initial dose for patients with moderate hepatic impairment (Child Pugh B) is 0.3 mg twice a day (see section 5.2).
Maltese: Id-doża inizjali rrakkomandata għal pazjenti b'indeboliment moderat tal-fwied (Child Pugh B) hi 0.3 mg darbtejn kuljum (ara sezzjoni 5.2).
English: Grade 3 adverse reactions were observed in 35.8% of patients and Grade 4 adverse reactions in 2.5% of patients.
Maltese: Kienu osservati reazzjonijiet avversi fi Grad 3 f'35.8% tal-pazjenti u reazzjonijiet avversi fi Grad 4 fi 2.5% tal-pazjenti.
English: Cholecystitis *, cholestasis
Maltese: Koleċistite*, kolestażi
English: Cholecystitis*, cholestasis
Maltese: Koleċistite *, kolestażi
English: Step 2
Maltese: Stadju 2
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP1B1 or 1B3, OAT1 or OAT3, OCT1 or OCT2, P-gp, BCRP, MRP2 and BSEP.
Maltese: F'livelli ta' dożi terapewtiċi pasireotide mhuwiex inibitur ta' UGT1A1, OATP1B1 jew 1B3, OAT1 jew OAT3, OCT1 jew OCT2, P-gp, BCRP, MRP2, u BSEP.
English: Table 1 Adverse reactions by preferred term for pasireotide intramuscular use
Maltese: Tabella 1 Reazzjonijiet mhux mixtieqa skont it-terminu ppreferut għal pasireotide użu
English: In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Maltese: Fi studju kliniku f'pazjenti b'indeboliment fil-funzjoni tal-fwied (Child-Pugh A, B u C), instabu differenzi klinikament qawwija f'pazjenti b'indeboliment tal-fwied moderat u gravi (Child-Pugh B u C).
English: The most common adverse reactions (incidence ≥1/10) from the pooled safety data from the phase III studies C2305 and C2402 were (in decreasing order): diarrhoea (most common in study C2305), cholelithiasis, hyperglycaemia (most common in study C2402) and diabetes mellitus.
Maltese: III C2305 u C2402 kienu (mill-ogħla sal-inqas frekwenti): dijarrea (l-aktar komuni fl-istudju C2305), kolelitijasi, ipergliċemija (l-aktar komuni fl-istudju C2402) u dijabete mellitus.
English: Sinus bradycardia, QT prolongation
Maltese: Bradikardija tas-sinus, titwil tal-QT
English: - Store in a refrigerator (2°C-8°C).
Maltese: - Aħżen fi friġġ (2C - 8C).
English: Signifor 40 mg and Signifor 60 mg are also available in multipacks containing 3 intermediate packs.
Maltese: Signifor 40 mg u Signifor 60 mg huma wkoll disponibbli f'pakketti b'ħafna li fihom 3 pakketti ta' daqs medju.
English: Plasma protein binding is moderate (88%) and independent of concentration.
Maltese: It-twaħħil malproteina tal-plażma hu moderat (88%) u indipendenti mill-konċentrazzjoni.
English: Step 2:
Maltese: Stadju 2:
English: Pasireotide 0.6 mg twice daily % change (n)
Maltese: Pasireotide 0.6 mg darbtejn kuljum bidla % (n)
English: The overall incidence of hyperglycaemia-related adverse reactions was 75.3% (all grades) and 22.7% (CTC Grade 3).
Maltese: L-inċidenza sħiħa ta' reazzjonijiet avversi b'rabta mal-ipergliċemija kienet ta' 75.3% (il-gradi kollha) u 22.7% (CTC Grad 3).
English: A total of 198 patients were randomised to receive pasireotide intramuscular use 40 mg (n=65), pasireotide intramuscular use 60 mg (n=65) or active control (n=68).
Maltese: Total ta' 198 pazjent kienu randomizzati sabiex jirċievu 40 mg pasireotide użu għal ġol-muskoli (n=65), 60 mg pasireotide użu għal ġol-muskoli (n=65) u kontroll bl-attiv (n=68). 192 pazjent kienu kkurati.
English: Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 10 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 20 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 30 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 40 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 60 mg trab u solvent għal suspensjoni għall-injezzjoni pasireotide
English: Studies in rats have shown effects on female reproductive parameters (see section 5.3).
Maltese: Studji f'firien urew effetti fuq il-parametri riproduttivi femminili (ara sezzjoni 5.3).
English: Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection
Maltese: Signifor 10 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 20 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 30 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 40 mg trab u solvent għal suspensjoni għall-injezzjoni Signifor 60 mg trab u solvent għal suspensjoni għall-injezzjoni
English: Based on population pharmacokinetic (PK) analyses, the estimated CL/F was approximately 4.8 to 6.5 litres/h for typical Cushing's disease patients, and approximately 5.6 to 8.2 litres/h for typical acromegaly patients.
Maltese: Skont analiżi farmakokinetika (PK) fost il-popolazzjoni, is-CL/F stmat kien ta' madwar 4.8 sa 6.5 litri/h għal pazjenti b'marda ta' Cushing tipika, u ta' madwar 5.6 sa 8.2 litri/h għal pazjenti b'akromegalija tipika.
English: Step 3
Maltese: Stadju 3
English: Step 9:
Maltese: Stadju 9:
English: Health-related quality of life measured by AcroQol indicated statistically significant improvements from baseline to week 24 in the Physical, Psychological-Appearance and Global scores for the 60 mg group and the Physical sub-score for the 40mg group.
Maltese: Il-kwalità tal-ħajja b'rabta mas-saħħa kif imkejla minn AcroQol wriet titjib qawwi statistikament millinja bażi f'ġimgħa 24 skont l-iskors Physical, Psychological-Appearance and Global fil-grupp mogħti 60 mg u s-sottoskor Physical fil-grupp mogħti 40 mg.
English: Sinus bradycardia*, QT prolongation
Maltese: Bradikardija tassinus*, titwil tal-QT
English: Step 4
Maltese: Stadju 4
English: It is used to treat acromegaly in adult patients.
Maltese: Jintuża biex jittratta l-akromegalija f'pazjenti adulti.
English: Step 4:
Maltese: Stadju 4:
English: During your treatment with Signifor - Signifor controls over-production of cortisol.
Maltese: Matul il-kura b'Signifor - Signifor jikkontrolla l-produzzjoni eċċessiva ta' kortisol.
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 5 (3.1%) and 4 (2.5%) patients, respectively.
Maltese: Reazzjonijiet mhux mixtieqa ta' ipergliċemija u dijabete mellitus wasslu għal twaqqif tal-istudju f'5 (3.1%) u 4 (2.5%) pazjenti, rispettivament.
English: Median change in UFC (% from baseline)
Maltese: Bidla medja fil-UFC (% mil-linja bażi)
English: Multipack: 30 (5 packs of 6) ampoules.
Maltese: Pakkett b'ħafna: 30 ampulla (5 pakketti ta' 6).
English: Signifor is a medicine that contains the active substance pasireotide.
Maltese: Signifor huwa mediċina li fih is-sustanza attiva pasireotide.
English: Based on in vitro data pasireotide appears to be a substrate of efflux transporter P-gp (P-glycoprotein).
Maltese: Skont tagħrif in vitro pasireotide jidher li hu sottostrat tat-trasportatur tal-effluss P-gp (Pglikoproteina).
English: Step 3:
Maltese: Stadju 3:
English: Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Maltese: Pasireotide juri tneħħija baxxa (CL/F ~7.6 litri/h għal voluntiera b'saħħithom u ~3.8 litri/h għal pazjenti morda bil-marda ta' Cushing).
English: At month 7, a mUFC response was achieved in 41.9% and 40.8% of patients randomised to starting doses of 10 mg and 30 mg, respectively.
Maltese: Fis-7 xahar, rispons ta' mUFC inkiseb fil-41.9% u fl-40.8% tal-pazjenti randomizzati biex jingħataw dożi inizjali ta' 10 mg u 30 mg, rispettivament.
English: Pasireotide did not affect insulin sensitivity.
Maltese: Pasireotide ma affettwax is-sensittività għall-insulina.
English: Signifor 0.9 mg solution for injection EU/1/12/753/009-0012
Maltese: Signifor 0.9 mg soluzzjoni għal injezzjoni EU/1/12/753/009-0012
English: The usual starting dose of Signifor in Cushing's disease is 10 mg every 4 weeks.
Maltese: Normalment id-doża inizjali ta' Signifor għall-marda ta' Cushing hi ta' 10 mg kull 4 ġimgħat.
English: Signifor reduces the production of these hormones and possibly also the size of the adenoma.
Maltese: Signifor inaqqas il-produzzjoni ta' dawn l-ormoni u possibbilment ukoll id-daqs tal-adenoma.
English: Sites showing signs of inflammation or irritation should be avoided.
Maltese: Postijiet li juru infjammazzjoni jew irritazzjoni għandhom ikunu evitati.
English: Multipack: 60 (10 packs of 6) ampoules.
Maltese: Pakkett b'ħafna: 60 ampulla (10 pakketti ta' 6).
English: Step 7:
Maltese: Stadju 7:
English: erythromycin, pentamidine); - medicines to treat fungal infections (ketoconazole, except in shampoo); - medicines to treat certain psychiatric disorders (chlorpromazine, thioridazine, fluphenazine,
Maltese: erythromycin, pentamidine); - mediċini li jittrattaw infezzjonijiet tal-fungu (ketoconazole, ħlief fix-xampù); - mediċini li jittrattaw ċerti disturbi psikjatriċi (chlorpromazine, thioridazine, fluphenazine,
English: - Prolonged QT interval (an abnormal electrical signal in your heart that can be seen in tests).
Maltese: - Intervall imtawwal tal-QT (sinjal elettriku anormali f'qalbek li jista' jidher fit-testijiet).
English: Signifor 0.6 mg solution for injection EU/1/12/753/005-008
Maltese: Signifor 0.6 mg soluzzjoni għal injezzjoni EU/1/12/753/005-008
English: Step 6:
Maltese: Stadju 6:
English: Pasireotide 0.9 mg twice daily % change (n)
Maltese: Pasireotide 0.9 mg darbtejn kuljum bidla % (n)
English: In Cushing's disease patients, pasireotide demonstrates linear and time-independent pharmacokinetics in the dose range of 0.3 mg to 1.2 mg twice a day.
Maltese: F'pazjenti morda bil-marda ta' Cushing, pasireotide juri farmakokinetiċi lineari u indipendenti millħin fil-firxa tad-doża minn 0.3 mg sa 1.2 mg darbtejn kuljum.
English: Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
Maltese: Signifor m'għandux jintuża f'pazjenti b'indeboliment gravi talfwied (Child Pugh C) (ara sezzjonijiet 4.3 u 4.4).
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Maltese: Ormoni u analogy pitwitarji u ipotalamiċi, somatostatin u analogi, Kodiċi ATC:
English: Adverse reactions are listed according to MedDRA primary system organ class.
Maltese: Irreazzjonijiet avversi jinsabu mniżżla skont is-sistema tal-klassifika tal-organi MedDRA.
English: Common (may affect up to 1 in 10 people) - Low cortisol levels.
Maltese: Komuni (jista' jaffettwa sa persuna waħda minn kull 10) - Livelli baxxi tal-kortisol.
English: The proportion of patients who either attained mUFC ≤ULN or a mUFC reduction from baseline of at least 50% was 50.0% in the 10 mg dose group and 56.6% in the 30 mg dose groups (Table 5).
Maltese: Il-proporzjon ta' pazjenti li jew kisbu mUFC ta' ≤ULN jew tnaqqis tal-mUFC mil-linja bażi ta' mill-inqas 50% kien ta' 50% fil-grupp mogħti doża ta' 10 mg u ta' 56.6% fil-gruppi mogħtija doża ta' 30 mg (Tabella 5).