FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analyses of Signifor suggest that race and gender do not influence pharmacokinetic parameters.
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni mogħtija Signifor jissuġġerixxu li r-razza u s-sess ma jinfluwenzawx il-parametri farmakokinetiċi.
English: For a range of 60-100 kg the reduction in AUCss with increasing weight is predicted to be approximately 27%, which is considered moderate and of minor clinical significance.
Maltese: Huwa mbassar li għall-firxa ta' bejn 60 u 100 kg it-tnaqqis fl-AUCss maż-żieda fil-piż tkun ta' madwar 27%, meqjus moderat u ta' ftit importanza klinika.
English: Also contains: Mannitol, tartaric acid, sodium hydroxide, water for injections.
Maltese: Fih ukoll: Mannitol, tartaric acid, sodium hydroxide, ilma għall-injezzjonijiet.
English: Furthermore, a higher proportion of patients on pasireotide intramuscular use (18.5% and 10.8% for 40 mg and 60 mg, respectively) than active comparator (1.5%) achieved a reduction in tumour volume of at least 25%.
Maltese: 8% għal 40 mg u 60 mg, rispettivament) mill-komparatur attiv (1.5%) li kisbu tnaqqis fil-volum tat-tumur ta' mill-inqas 25%.
English: Hypocortisolism
Maltese: Ipokortisoliżmu
English: Baseline characteristics were balanced between the two randomised dose groups, except for marked differences in the mean value of baseline 24-hour UFC (1156 nmol/24 h for the 0.6 mg twice daily group and 782 nmol/24 h for the 0.9 mg twice daily group; normal range 30-145 nmol/24 h).
Maltese: Il-karatteristiċi fil-linja bażi kienu bbilanċjati bejn iż-żewġ gruppi mogħtija d-doża b'mod randomizzat, ħlief għal differenzi ewlenin fil-valur medju fil-linja bażi tal-UFC fuq medda ta' 24 siegħa (1156 nmol/24 h għall-grupp mogħti 0.6 mg darbtejn kuljum u 782 nmol/24 h għall-grupp mogħti 0.9 mg darbtejn kuljum; il-firxa normali kienet 30-145 nmol/24 h).
English: In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
Maltese: Fi studju C2402, l-uniku valur remot kien il-valur ta' QTcF >480 ms f'pazjent 1 fil-grupp mogħti 40 mg pasireotide użu għal ġol-muskoli.
English: Other medicines and Signifor
Maltese: Mediċini oħra u Signifor
English: Step 6
Maltese: Stadju 6
English: Glucose metabolism
Maltese: Il-metaboliżmu tal-glukosju
English: Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection
Maltese: Signifor 0.3 mg soluzzjoni għall-injezzjoni Signifor 0.6 mg soluzzjoni għall-injezzjoni Signifor 0.9 mg soluzzjoni għall-injezzjoni
English: Diarrhoea, nausea, abdominal pain*
Maltese: Dijarrea, dardir, uġigħ addominali*
English: Monitoring of pituitary function (e.g. TSH/free T4, GH/IGF-1) before and periodically during Signifor therapy should therefore be considered, as clinically appropriate.
Maltese: TSH/liberu T4, GH/IGF-1) qabel it-terapija b'Signifor u minn żmien għal żmien waqtha, kif jixraq klinikament.
English: Pasireotide
Maltese: INDIVIDWALI
English: In the studied age range 18-73 years, the area under the curve at steady state for one dosing interval of 12 hours (AUCss) is predicted to range from 86% to 111% of that of the typical patient of 41 years.
Maltese: Fil-medda ta' età studjata ta' bejn 18-73 sena, huwa mbassar li ż-żona taħt il-kurva fi stat wieqaf f'każ ta' intervall wieħed fl-għoti tad-doża ta' 12-il siegħa (AUCss) tkun minn 86% sa 111% ta' dik tal-pazjent tipiku ta' 41 sena.
English: Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products, such as beta blockers (e.g. metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (e.g. rivastigmine, physostigmine), certain calcium channel blockers (e.g. verapamil, diltiazem, bepridil), certain antiarrhythmics (see also section 4.4).
Maltese: Huwa rrakkomandat monitoraġġ kliniku tar-rata tat-taħbit tal-qalb, l-aktar fil-bidu tal-kura, f'pazjenti li qed jingħataw pasireotide flimkien ma' prodotti mediċinali bradikardijaċi, bħalma huma mblukkaturi beta (eż. metoprolol, carteolol, propranolol, sotalol), impedituri ta' acetylcholinesterase (eż. rivastigmine, physostigmine), ċerti antagonisti tal-kalċju (eż. verapamil, diltiazem, bepridil), ċerti antiarritmiċi (ara wkoll sezzjoni 4.4).
English: In healthy volunteers, pasireotide is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
Maltese: F'voluntiera b'saħħithom, pasireotide jinfirex ħafna bil-volum ta' distribuzzjoni jidher kbir (Vz/F >100 litru).
English: Pasireotide was not genotoxic in in vitro and in vivo assays.
Maltese: Pasireotide ma kienx ġenotossiku waqt analiżijiet in vitro u in vivo.
English: Overall reductions in these parameters tended to be greater in patients that were mUFC responders.
Maltese: It-tnaqqis totali f'dawn il-parametri kellu t-tendenza jkun akbar fost pazjenti li rrispondew għall-mUFC.
English: 1 pre-filled syringe with 2 ml solvent 1 safety-engineered needle 1 vial adapter
Maltese: Siringa waħda mimlija għal-lest b'2 ml solvent Labra waħda b'sistema protettiva Adattur wieħed għall-kunjett
English: Ampoules of Signifor of different strengths (0.3 mg, 0.6 mg and 0.9 mg) are available to match the specific dose prescribed by your doctor.
Maltese: Jeżistu ampulli ta' Signifor ta' diversi qawwiet (0.3 mg, 0.6 mg u 0.9 mg) skont id-doża speċifika preskritta mit-tabib tiegħek.
English: In a randomised double-blinded mechanism study conducted in healthy volunteers, the development of hyperglycaemia with pasireotide administered as pasireotide subcutaneous use at doses of 0.6 and 0.9 mg twice a day was related to significant decreases in insulin secretion as well as incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Maltese: Fi studju randomizzat b'mekkaniżmu double-blind magħmul fost voluntiera b'saħħithom, l-iżvilupp ta' ipergliċemija b'pasireotide mogħti bħala pasireotide użu għal taħt il-ġilda b'dożi ta' 0.6 u 0.9 mg darbtejn kuljum kien releatat ma' tnaqqis qawwi fis-sekrezzjoni tal-insulina kif ukoll bħala ormoni talinkretin (i.e. peptide-1 li jixbah il-glukagon [GLP-1] u polipeptide insulinotropiku dipendenti fuq ilglukosju [GIP]).
English: The primary efficacy endpoint was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 μg/l and normalisation of sex- and age-adjusted IGF-1) at week 24 with pasireotide intramuscular use 40 mg or 60 mg versus continued treatment with active control (octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg), separately.
Maltese: L-endpoint primarju tal-effikaċja kien li jqabbel il-proporzjon ta' pazjenti li kisbu kontroll bijokimiku (iddefinit bħala medja tal-livelli ta' GH ta' <2.5 μg/l u n-normalizzazzjoni tal-IGF-1 aġġustat skont issess u l-età) fl-24 ġimgħa b'40 mg jew 60 mg pasireotide użu għal ġol-muskoli kontra kura kontinwa bil-kontroll tal-attiv (30 mg octreotide għal ġol-muskoli jew 120 mg lanreotide injezzjoni għal taħt ilġilda fil-fond), separatament.
English: The primary efficacy endpoint was met; the percentage of patients achieving biochemical control was 31.3% and 19.2% for pasireotide intramuscular use and octreotide intramuscular use, respectively, demonstrating a statistically significant superior result favouring pasireotide intramuscular use (p-value = 0.007) (Table 4).
Maltese: L-endpoint primarju tal-effikaċja ntlaħaq; il-perċentwali ta' pazjenti li kisbu kontroll bijokimiku kien ta' 31.3% u 19.2% għal pasireotide użu għal ġol-muskoli u octreotide użu għal ġolmuskoli, rispettivament, li juri riżultat superjuri u sinjifikanti statistikament favur pasireotide użu għal ġol-muskoli (valur-p = 0.007) (Tabella 4).
English: Component of a multipack.
Maltese: Komponent tal-pakkett b'ħafna.
English: Type 2 diabetes mellitus, glucose tolerance impaired, decreased appetite
Maltese: Dijabete mellitus tattip 2, indeboliment tattolleranza għallglukosju, nuqqas ta' aptit
English: Twelve months after crossover, the percentage of patients achieving biochemical control was 17.3% (14/81) for pasireotide intramuscular use and 0% (0/38) for octreotide intramuscular use.
Maltese: Tnax-il xahar wara din il-bidla, il-perċentwali ta' pazjenti li kisbu kontroll bijokimiku kienet ta' 17.3% (14/81) għal pasireotide użu għal ġol-muskoli u 0% (0/38) għal octreotide użu għal ġol-muskoli.
English: Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Maltese: Trab: kunjett (tal-ħġieġ) wieħed jagħti fil-kannella bi stopper tal-lastku (lastku tal-chlorobutyl), li fih is-sustanza attiva (pasireotide).
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 3 (2.0%) and 4 patients (2.7%), respectively.
Maltese: Reazzjonijiet avversi ta' ipergliċemija u dijabete mellitus wasslu għat-twaqqif għal kollox tal-istudju fi 3 (2.0%) u 4 pazjenti (2.7%), rispettivament.
English: Somatostatin analogues bind to hsst receptors with different potencies (see Table 2).
Maltese: L-analogi ta' somatostatin jeħlu ma' riċetturi ta' hsst b'qawwiet differenti (ara Tabella 2).
English: Glycosylated haemoglobin increased, alanine aminotransferase increased, aspartate aminotransferase increased, gammaglutamyltransferase increased, blood glucose increased, blood creatine phosphokinase increased, lipase increased
Maltese: Żieda fl-emoglobina ta' glycosylated, żieda fl-alanina aminotransferasi, żieda fl-aspartate aminotransferase, żieda filgammaglutamiltransfer asi, żieda fil-glukosju fid-demm, żieda filfosfokinasi tal-kreatina fid-demm, żieda fillipase
English: Glycaemic status (fasting plasma glucose/haemoglobin A1c [FPG/HbA1c]) should be assessed prior to starting treatment with pasireotide.
Maltese: Wieħed għandu jkejjel l-istat gliċemiku (il-livell tal-glukosju fil-plażma/emoglobina A1c [FPG/HbA1c] f'pazjenti sajmin) qabel ma tinbeda l-kura b'pasireotide.
English: In study C2402, grade 3 elevated fasting glucose levels were reported in 14.3% and 17.7% of acromegaly patients treated with pasireotide intramuscular use 40 mg and 60 mg respectively, and in no patients in the active control group.
Maltese: Fl-istudju C2403,il-livelli għoljin ta' glukosju f'persuni sajma kienu rrappurtati bi grad 3 f'14.3% u fi 17.7% tal-pazjenti b'akromegalija kkurati b'pasireotide użu għal ġol-muskoli 40 mg u 60 mg, rispettivament, u fl-ebda pazjent fil-grupp ikkontrollat bl-attiv.
English: Signifor 60 mg powder and solvent for suspension for injection EU/1/12/753/016-017
Maltese: Signifor 60 mg trab u solvent għal suspensjoni għall-injezzjoni EU/1/12/753/016-017
English: Included in the injection kit:
Maltese: Inkluż fil-pakkett bl-injezzjoni:
English: The eligibility criteria included a mean urinary free cortisol (mUFC) value of between 1.5 and 5 times upper limit of normal (ULN) at screening.
Maltese: Il-kriterji ta' eliġibbiltà kienu jinkludu valur medju tal-kortisol liberu urinarju (mUFC) ta' bejn 1.5 u 5 drabi mill-ogħla limitu tan-normal (ULN) dakinhar tal-iscreening.
English: The development of hyperglycaemia appears to be related to decreases in secretion of insulin and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Maltese: L-iżvilupp ta' ipergliċemija jidher li hu relatat mat-tnaqqis fit-tnixxija tal-insulina u tal-ormoni talinkretin (i.e. peptide-1 li jixbah il-glukagon [GLP-1] u polipeptide insulinotropiku dipendenti fuq ilglukosju [GIP]).
English: Signifor 20 mg: each vial contains 20 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 20 mg: kull kunjett fih 20 mg pasireotide (bħala pasireotide pamoate).
English: Episodes of torsade de pointes were not observed in any clinical study with pasireotide.
Maltese: Ma kenux osservati episodji ta' torsade de pointes fi kwalunkwe studju kliniku b'pasireotide.
English: QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups.
Maltese: QTcF ta' >480 ms kien irrappurtat għal 3 kontra 2 pazjenti fil-grupp mogħti pasireotide użu għal ġol-muskoli u fil-grupp mogħti octreotide użu għal ġol-muskoli, u kien irrappurtat QTcF ta' >60 ms imtawwal mil-linja bażi għal 2 kontra pazjent 1 fil-gruppi rispettivi tagħhom.
English: Once the ampoule is open, put it upright on a clean, flat surface.
Maltese: Wara li tkun ftaħt l-ampulla, qegħda wieqfa fuq superfiċje nadifa u ċatta.
English: Check the expiry date and the dose
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Signifor 0.3 mg injection pasireotide
Maltese: Signifor 0.3 mg injezzjoni pasireotide
English: pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone); - medicines to treat hay fever and other allergies (terfenadine, astemizole, mizolastine); - medicines used in the prevention or treatment of malaria (chloroquine, halofantrine,
Maltese: pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone); - mediċini li jittrattaw il-hay fever u allerġiji oħrajn (terfenadine, astemizole, mizolastine); - mediċini użati fil-prevenzjoni jew il-kura tal-malarja (chloroquine, halofantrine, lumefantrine); - mediċini li jikkontrollaw il-pressjoni tad-demm bħalma huma:
English: Single use.
Maltese: Jintuża darba.
English: In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
Maltese: Fl-istudju G2304 dwar il-marda ta' Cushing, kien irrappurtat valur tal-QTcF ta' >480 ms għal 2 pazjenti.
English: Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 10 mg to 60 mg every 4 weeks.
Maltese: Wara dożi multipli fix-xahar, pasireotide użu għal ġol-muskoli juri espożizzjoni farmakokinetika proporzjonali approssimattiva għad-doża meta tingħata doża ta' bejn 10 mg u 60 mg kull 4 ġimgħat.
English: Signifor 0.6 mg injection pasireotide
Maltese: Signifor 0.6 mg injezzjoni pasireotide
English: - Do not use this medicine after the expiry date which is stated on the ampoule label and carton after “EXP”.
Maltese: - Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tabella tal-ampulla u l-kartuna wara “EXP”/“JIS”.
English: Inadequately controlled patients in study C2402 are defined as patients with a mean GH concentration of a 5-point profile over a 2-hour period >2.5 μg/l and sex- and age-adjusted IGF-1 >1.3 × ULN.
Maltese: Fl-istudju C2402 pazjenti mhux ikkontrollati kif jixraq huma ddefiniti bħala pazjenti b'medja talkonċentrazzjoni ta' GH bi profil ta' 5-punti tul medda ta' sagħtejn >2.5 μg/l u IGF-1 >1.3 × ULN aġġustat skont is-sess u l-età.
English: Pituitary hormones
Maltese: GĦAMLA FARMAĊEWTIKA
English: Signifor 0.9 mg injection pasireotide
Maltese: Signifor 0.9 mg injezzjoni pasireotide
English: Medicinal products that prolong the QT interval
Maltese: Prodotti mediċinali li jtawlu l-intervall tal-QT
English: Glycosylated haemoglobin increased
Maltese: Żieda fl-emoglobina glikosilata
English: Important information about some of the ingredients of Signifor Signifor contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Cushing's disease patients with poor glycaemic control (as defined by HbA1c values >8% while receiving antidiabetic therapy) may be at higher risk of developing severe hyperglycaemia and associated complications (e.g. ketoacidosis).
Maltese: Pazjenti b'kontroll gliċemiku batut (kif iddefinit bil-valuri ta' HbA1c >8% huma u jingħataw terapija antidijabetika) jista' jkollhom aktar riskju li jiżviluppaw ipergliċemija u kumplikazzjonijiet gravi relatati (eż. ketoaċidożi).
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Maltese: Studji f'firien li ngħataw pasireotide minn taħt il-ġilda wrew effetti fuq il-parametri riproduttivi femminili (ara sezzjoni 5.3).
English: - Inspect the ampoule.
Maltese: - Iċċekkja l-ampulla.
English: Hepatic impairment Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Maltese: Mhuwiex meħtieġ aġġustament tad-doża f'pazjenti b'indeboliment ħafif u moderat fil-funzjoni talkliewi (Child Pugh A).
English: Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 60 mg: kull kunjett fih 60 mg pasireotide (bħala pasireotide pamoate).
English: Rare cases of concurrent elevations in ALT (alanine aminotransferase) greater than 3 x ULN and bilirubin greater than 2 x ULN have also been observed (see section 4.8).
Maltese: Kienu osservati wkoll każijiet rari ta' elevazzjonijiet fl-istess ħin tal-ALT (alanine aminotransferase) ta' aktar minn 3 x ULN u tal-bilirubin ta' aktar minn 2 x ULN (ara sezzjoni 4.8).
English: In study C2305, grade 3 elevated fasting glucose levels were reported in 9.7% and 0.6% and grade 4 in 0.6% and 0% of acromegaly patients treated with pasireotide intramuscular use and octreotide intramuscular use, respectively.
Maltese: Fl-istudju C2305, il-livelli għoljin ta' glukosju f'persuni sajma kienu rrappurtati bi grad 3 f'9.7% u f'0.6% u bi grad 4 f'0.6% u f'0% tal-pazjenti b'akromegalija kkurati b'pasireotide użu għal ġol-muskoli u octreotide użu għal ġol-muskoli,
English: Glucose metabolism disorders
Maltese: Disturbi fil-metaboliżmu tal-glukosju
English: Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 20 mg trab u solvent għal suspensjoni għall-injezzjoni Kunjett wieħed fih 20 mg pasireotide (bħala pasireotide pamoate).
English: The most common adverse reactions (incidence ≥10%) were diarrhoea, nausea, abdominal pain, cholelithiasis, injection site reactions, hyperglycaemia, diabetes mellitus, fatigue and glycosylated haemoglobin increased.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥10%) kienu dijarrea, dardir, uġigħ fl-addome, kolelitijasi, reazzjonijiet fis-sit tal-injezzjoni, ipergliċemija, dijabete mellitus, għeja u żieda fl-emoglobina glikosilata.
English: 1 vial of powder + 1 pre-filled syringe with 2 ml solvent+ 1 safety-engineered needle + 1 vial adapter.
Maltese: Kunjett wieħed bit-trab + siringa waħda mimlija għal-lest b'2 ml solvent + labra waħda b'sistema protettiva + adattur wieħed għall-kunjett.
English: • The injection kit must reach room temperature.
Maltese: • L-injezzjoni trid tilħaq it-temperatura tal-kamra.
English: Patients were randomised in a 1:1 ratio to one of two treatment groups in each of the following two strata: 1) patients who had undergone one or more pituitary surgeries but had not been treated medically or 2) de novo patients presenting a visible pituitary adenoma on MRI who had refused pituitary surgery or for whom pituitary surgery was contraindicated.
Maltese: Il-pazjenti kienu randomizzati bi proporzjoni ta' 1:1 f'wieħed miż-żewġ gruppi ta' kura f'kull waħda miż-żewġ strati li ġejjin: 1) pazjenti li kienu għamlu operazzjoni pitwitarja waħda jew aktar imma li ma kenux ikkurati medikament jew 2) pazjenti de novo li ppreżentaw adenoma pitwitarja viżibbli fl-MRI u li rrifjutaw li ssirilhom operazzjoni pitwitarja jew li għalihom operazzjoni pitwitarja kienet kontraindikata.
English: The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus.
Maltese: III tal-istudju G2304 kienu ipergliċemija, dijarrea, kolelitijasi u dijabete mellitus.
English: Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection pasireotide
Maltese: Informazzjoni għall-utent Signifor 0.3 mg soluzzjoni għall-injezzjoni Signifor 0.6 mg soluzzjoni għall-injezzjoni Signifor 0.9 mg soluzzjoni għall-injezzjoni pasireotide
English: Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 40 mg: kull kunjett fih 40 mg pasireotide (bħala pasireotide pamoate).
English: Signifor 20 mg powder for injection pasireotide
Maltese: Signifor 20 mg trab għall-injezzjoni pasireotide
English: The adverse reactions in Table 1 include events reported in the pivotal studies with the intramuscular formulation in patients with acromegaly and with Cushing's disease.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 jinkludu episodji rrappurtati fl-istudji pivotali dwar il-formulazzjoni intramuskolari f'pazjenti b'akromegalija u bil-marda ta' Cushing.
English: Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing's disease patients.
Maltese: L-aktar anormalità tal-laboratorju fi Grad 3 rrappurtata spiss kienet żieda fil-glukosju (23.2% talpazjenti) waqt it-III fażi tal-istudju fost pazjenti morda bil-marda ta' Cushing.
English: Signifor is available in packs containing 6 ampoules or in multipacks containing 18 (3 packs of 6), 30 (5 packs of 6) or 60 (10 packs of 6) ampoules.
Maltese: Signifor jinsab f'pakketti li fihom 6 ampulli jew f'pakketti b'ħafna li fihom 18 (3 pakketti ta' 6), 30 (5 pakketti ta' 6) jew 60 (10 pakketti ta' 6) ampulla.
English: Signifor 10 mg: each vial contains 10 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 10 mg: kull kunjett fih 10 mg pasireotide (bħala pasireotide pamoate).
English: Acromegaly: the recommended initial dose for acromegaly patients with moderate hepatic impairment (Child Pugh B) is 20 mg every 4 weeks, and the maximum recommended dose for these patients is 40 mg every 4 weeks (see section 5.2).
Maltese: Akromegalija:id-doża inizjali rrakkomandata għal pazjenti b'akromegalija b'indeboliment moderat talfwied (Child Pugh B) hi ta' 20 mg kull 4 ġimgħat, u d-doża massima rrakkomandata għal dawn il pazjenti hi ta' 40 mg kull 4 ġimgħat (ara sezzjoni 5.2).
English: Acromegaly study C2402, inadequately controlled patients Study C2402 was a phase III, multicentre, randomised, parallel-group, three-arm study of double-blind pasireotide intramuscular use 40 mg and 60 mg versus open-label octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg in patients with inadequately controlled acromegaly.
Maltese: III, multiċentriku, randomizzat bi gruppi paralleli b'40 u 60 mg pasireotide użu għal ġol-muskoli double-blind kontra 30 mg octreotide użu għal ġolmuskoli jew 120 mg lanreotide injezzjoni għal taħt il-ġilda fil-fond open-label f'pazjenti b'akromegalija mhux ikkontrollati kif jixraq.
English: Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Maltese: Solvent: siringa (tal-ħġieġ) mingħajr kulur mimlija għal-lest bi stopper fuq quddiem u mal-planġer (tal-lastku tal-chlorobutyl), li fiha 2 ml solvent.
English: Keep the plunger pressed down and hold the syringe in place for 5 seconds.
Maltese: Ħalli l-planġer magħfus 'l isfel u żomm is-siringa f'postha għal 5 sekondi.
English: - Keep this leaflet.
Maltese: - Għeja esaġerata.
English: Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 60 mg trab u solvent għal suspensjoni għall-injezzjoni Kunjett wieħed fih 60 mg pasireotide (bħala pasireotide pamoate).
English: Thereafter liver function should be monitored as clinically indicated.
Maltese: Għaldaqstant għandu jkun hemm monitoraġġ tal-funzjoni talfwied kif indikat klinikament.
English: • metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines); - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Maltese: • metformin, liraglutide, vildagliptin, nateglinide (mediċini antidijabetiċi);