FrancophonIA/ELRC3.0 huggingface dataset:
English: a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″)
Maltese: a Kunjett wieħed li fih it-trab b Siringa waħda mimlija għal-lest li fiha s-solvent c Adattur wieħed għall-kunjett għar-rikostituzzjoni tal-prodott mediċinali d Labra waħda b'sistema protettiva (20G x 1.5″)
English: Rare cases of concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN have been observed.
Maltese: Kienu osservati każijiet rari ta' żidiet konkurrenti fl-ALT ta' aktar minn 3 x ULN u ta' bilirubin ta' aktar minn 2 x ULN.
English: In the pivotal study with patients inadequately controlled on another somatostatin analogue, the proportion of patients not previously treated with anti-diabetic agents who required commencement of anti-diabetic therapy during the study was 17.5% and 16.1% in the Signifor 40 mg and 60 mg arms compared to 1.5% in the active control arm.
Maltese: Fl-istudju pivotali ma' pazjenti kkontrollati mhux kif jixraq mogħtija analogu ta' somatostatin ieħor, il-proporzjon ta' pazjenti li ma kenux ittrattati b'aġenti kontra ddijabete u li kienu jeħtieġu t-tnedija ta' terapija għal kontra d-dijabete matul l-istudju kien ta' 17.5% u 16.1% fost il-gruppi mogħtija Signifor 40 mg u 60 mg mqabbla mal-1.5% fost il-grupp ikkontrollat blattiv.
English: Common (may affect up to 1 in 10 people) - Prolonged QT interval (an abnormal electrical signal in your heart that can be seen in tests) - Loss of appetite - Vomiting - Headache - Dizziness - Hair loss - Itching (pruritus) - Muscle pain (myalgia) - Joint pain (arthralgia) - Abnormal results of liver function tests - Abnormal results of pancreatic function tests - Abnormal blood coagulation properties
Maltese: Komuni (jista' jaffettwa lil pazjent wieħed minn kull 10) - Intervall imtawwal tal-QT (sinjal elettriku anormali f'qalbek li jista' jidher fit-testijiet) - Nuqqas ta' aptit - Rimettar - Uġigħ ta' ras - Sturdament - Telf ta' xagħar - Ħakk (pruritus) - Uġigħ fil-muskoli (mijalġja)
English: Signifor 40 mg powder and solvent for suspension for injection EU/1/12/753/014-015
Maltese: Signifor 40 mg trab u solvent għal suspensjoni għall-injezzjoni EU/1/12/753/014-015
English: Facial rubor improved in 43.5% (47/108) of patients, and more than a third of patients demonstrated improvement in supraclavicular fat pad (34.3%) and dorsal fat pad (34.6%).
Maltese: Kien hemm titjib fejn tidħol il-ħmura fuq il-wiċċ fi 43.5% (47/108) tal-pazjenti, u aktar minn terz tal-pazjenti wrew titjib fil-kuxxinetti tax-xaħam supraklavikulari (34.3%) u fil-kuxxinetti tax-xaħam dorsali (34.6%).
English: Signifor 0.9 mg: One ampoule of 1 ml solution contains 0.9 mg pasireotide (as pasireotide diaspartate).
Maltese: Signifor 0.9 mg: Ampulla waħda ta' soluzzjoni ta' 1 ml fiha 0.9 mg pasireotide (bħala pasireotide diaspartate).
English: The therapeutic benefits of a reduction in growth hormone (GH) levels and normalisation of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients and of a reduction or normalisation of serum cortisol levels in female patients with Cushing's disease could potentially restore fertility.
Maltese: Il-benefiċċji terapewtiċi ta' tnaqqis fil-livelli tal-ormon tat-tkabbir (GH) u normalizzazzjoni talkonċentrazzjoni tal-fattur tat-tkabbir 1 simili għall-insulina (IGF-1) f'pazjenti nisa b'akromegalija u tnaqqis jew normalizzazzjoni tal-livelli ta' kortisol fis-serum f'pazjenti nisa bil-marda ta' Cushing jistgħu jwasslu sabiex terġa' tinġieb lura l-fertilità.
English: - If you are a sexually active woman, you should use an effective method of contraception during treatment.
Maltese: - Jekk inti mara attiva sesswalment, għandek tuża metodu effettiv ta' kontraċezzjoni matul ittrattament.
English: Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor.
Maltese: Il-kura ta' reazzjonijiet mhux mixtieqa ssusspettati jew rispons żejjed għall-kura (IGF-1 < limitu l-aktar baxx tan-normal) tistgħu jitolbu tnaqqis temporanju tad-doża ta' Signifor.
English: Table 4 Key results at month 12 - phase III study in acromegaly patients
Maltese: Tabella 4 Riżultati ewlenin fit-12-il xahar - studju f'fażi
English: Signifor 30 mg powder and solvent for suspension for injection One vial contains 30 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 30 mg trab u solvent għal suspensjoni għall-injezzjoni Kunjett wieħed fih 30 mg pasireotide (bħala pasireotide pamoate).
English: Like the natural peptide hormones somatostatin-14 and somatostatin-28 (also known as somatotropin release inhibiting factor [SRIF]) and other somatostatin analogues, pasireotide exerts its pharmacological activity via binding to somatostatin receptors.
Maltese: L-istess bħall-ormoni peptide naturali ta' somatostatin-14 u somatostatin-28 (magħrufin ukoll bħala fattur ta' inibizzjoni li jerħi s-somatotropin [SRIF]) u ta' analogi oħrajn ta' somatostatin, pasireotide jissokkta bl-attività farmakoloġika tiegħu billi jeħel mar-riċetturi ta' somatostatin.
English: Signifor 40 mg powder and solvent for suspension for injection One vial contains 40 mg pasireotide (as pasireotide pamoate).
Maltese: Signifor 40 mg trab u solvent għal suspensjoni għall-injezzjoni Kunjett wieħed fih 40 mg pasireotide (bħala pasireotide pamoate).
English: Signifor 60 mg powder for injection pasireotide
Maltese: Signifor 60 mg trab għall-injezzjoni pasireotide
English: Signifor 0.3 mg: One ampoule of 1 ml solution contains 0.3 mg pasireotide (as pasireotide diaspartate).
Maltese: Signifor 0.3 mg: Ampulla waħda ta' soluzzjoni ta' 1 ml fiha 0.3 mg pasireotide (bħala pasireotide diaspartate).
English: The percentage of patients achieving biochemical control, including those patients with IGF-1 <LLN was 25.9% in the pasireotide intramuscular use group and 0% in the octreotide intramuscular use group.
Maltese: Ilperċentwali ta' pazjenti li kisbu kontroll bijokimiku, inkluż dawk il-pazjenti b'IGF-1 ta' <LLN kienet ta' 25.9% fil-grupp mogħti pasireotide użu għal ġol-muskoli u ta' 0% fil-grupp mogħti octreotide użu għal ġol-muskoli.
English: One vial contains 60 mg pasireotide (as pasireotide pamoate).
Maltese: Kunjett wieħed fih 60 mg pasireotide (bħala pasireotide pamoate).
English: Powder and solvent for suspension for injection (powder for injection).
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni (trab għall-injezzjoni).
English: The study enrolled 162 patients with a baseline UFC >1.5 x ULN who were randomised in a 1:1 ratio to receive a subcutaneous dose of either 0.6 mg or 0.9 mg Signifor twice daily.
Maltese: L-istudju inkluda 162 pazjent fil-linja bażi tal-UFC >1.5 x ULN li ngħażlu b'mod randomizzat bi proporzjoni ta' 1:1 biex jingħataw doża għal taħt il-ġilda ta' 0.6 mg jew 0.9 mg Signifor darbtejn kuljum.
English: One Signifor ampoule
Maltese: Jekk tuża Signifor aktar milli suppost
English: Signifor 20 mg is available in unit packs containing one vial of powder with 20 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Maltese: Signifor 20 mg disponibbli f'pakketti b'wieħed li fihom kunjett wieħed bit-trab b'20 mg pasireotide u b'siringa waħda mimlija għal-lest b'2 ml solvent.
English: Signifor 20 mg powder and solvent for suspension for injection EU/1/12/753/013
Maltese: Signifor 20 mg trab u solvent għal suspensjoni għall-injezzjoni EU/1/12/753/013
English: Gallbladder and related events
Maltese: Il-bużżieqa tal-marrara u episodji relatati
English: In a clinical study with single subcutaneous dose administration of 900 µg pasireotide in subjects with impaired renal function, renal impairment of mild, moderate or severe degree, or end stage renal disease (ESRD) did not have a significant impact on total pasireotide plasma exposure.
Maltese: Waqt studju kliniku li fih ingħatat doża waħda minn taħt il-ġilda ta' 900 µg pasireotide lil pazjenti b'indeboliment fil-funzjoni tal-kliewi, b'indeboliment moderat tal-kliewi, bi grad moderat jew gravi, jew b'marda ta' insuffiċjenza tal-kliewi fl-aħħar stadju (ESRD) ma kienx hemm impatt qawwi fuq l-espożizzjoni totali ta' pasireotide fil-plażma.
English: In a human ADME study 55.9±6.63% of the radioactive pasireotide subcutaneous dose was recovered over the first 10 days after administration, including 48.3±8.16% of the radioactivity in faeces and 7.63±2.03% in urine.
Maltese: Fi studju dwar l-ADME fil-bnedmin 55.9±6.63% tad-doża radjuattiva kienet irkuprata matul l-ewwel 10t ijiem wara l-għoti tal-mediċina, inkluż 48.3±8.16% tar-radjuattività flippurgar u 7.
English: Signifor 20 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 20 mg trab u solvent għal suspensjoni għall-injezzjoni pasireotide
English: The starting dose was 40 mg for pasireotide intramuscular use and 20 mg for octreotide intramuscular use.
Maltese: Id-doża inizjali kienet ta' 40 mg għal pasireotide użu għal ġol-muskoli u ta' 20 mg għal octreotide użu għal ġol-muskoli.
English: A supportive efficacy analysis was conducted in which patients were further classified into 3 response categories regardless of up-titration at month 3: Fully controlled (UFC ≤1.0 x ULN), partially controlled (UFC >1.0 x ULN but with a reduction in UFC ≥50% compared to baseline) or uncontrolled (reduction in UFC <50%).
Maltese: Saret analiżi biex tgħin l-effikaċja li matulha l-pazjenti komplew ġew ikklassifikati iżjed fi 3 kategoriji ta' rispons indipendentament miż-żieda fid-doża fit-3 xahar: ikkontrollati għal kollox (UFC ≤1.0 x ULN), ikkontrollati parzjalment (UFC >1.0 x ULN imma bi tnaqqis fil-UFC ≥50% mqabbel mal-linja bażi) jew mhux ikkontrollati (tnaqqis fl-UFC ta' <50%).
English: Signifor 60 mg is available in unit packs containing one vial of powder with 60 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Maltese: Signifor 60 mg disponibbli f'pakketti b'wieħed li fihom kunjett wieħed bit-trab b'60 mg pasireotide u b'siringa waħda mimlija għal-lest b'2 ml solvent.
English: Coagulation abnormalities
Maltese: Anormalitajiet ta' koagulazzjoni
English: Signifor 40 mg powder for injection pasireotide
Maltese: Signifor 40 mg trab għall-injezzjoni pasireotide
English: Signifor 30 mg is available in unit packs containing one vial of powder with 30 mg pasireotide and one pre filled syringe with 2 ml solvent.
Maltese: Signifor 30 mg disponibbli f'pakketti b'wieħed li fihom kunjett wieħed bit-trab bi 30 mg pasireotide u b'siringa waħda mimlija għal-lest b'2 ml solvent.
English: The safety profile of Signifor was consistent with the somatostatin analogue class, except for the occurrence of hypocortisolism and degree of hyperglycaemia.
Maltese: Il-profil ta' sigurtà ta' Signifor kien konsistenti mal-klassi tal-analogi ta' somatostatin, ħlief għal meta kien hemm ipokortisoliżmu u l-grad ta' ipergliċemija.
English: Signifor 0.6 mg: One ampoule of 1 ml solution contains 0.6 mg pasireotide (as pasireotide diaspartate).
Maltese: Signifor 0.6 mg: Ampulla waħda ta' soluzzjoni ta' 1 ml fiha 0.6 mg pasireotide (bħala pasireotide diaspartate).
English: Signifor 10 mg powder and solvent for suspension for injection One vial contains 10 mg pasireotide (as pasireotide pamoate).
Maltese: U KWANTITATTIVA Signifor 10 mg trab u solvent għal suspensjoni għall-injezzjoni Kunjett wieħed fih 10 mg pasireotide (bħala pasireotide pamoate).
English: In healthy volunteers, pasireotide intramuscular use is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
Maltese: F'voluntiera b'saħħithom, pasireotide użu għal ġol-muskoli jinfirex ħafna bil-volum ta' distribuzzjoni jidher kbir (Vz/F >100 litru).
English: A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Maltese: Total ta' 201 pazjent morda bil-marda ta' Cushing ingħataw Signifor waqt it-II u t-III fażijiet tal-istudji.
English: Acromegaly study C2305 patients who had no prior medical treatment A phase III multicentre, randomised, blinded study was conducted to assess the safety and efficacy of pasireotide intramuscular use versus octreotide intramuscular use in medically naïve patients with active acromegaly.
Maltese: Studju dwar l-akromegalija C2305, pazjenti li ma ngħatawx kura medika qabel Kien sar studju blinded, multiċentriku, randomizzat f'fażi
English: AMPOULE LABEL
Maltese: IT-TIKKETTA TAL-AMPULLA
English: Included in the injection kit: a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″)
Maltese: a Kunjett wieħed li fih it-trab b Siringa waħda mimlija għal-lest li fiha s-solvent ċ Adattur wieħed għall-kunjett għar-rikostituzzjoni tal-prodott mediċinali d Labra waħda b'sistema protettiva (20G x 1.5″)
English: Signifor 30 mg powder and solvent for suspension for injection EU/1/12/753/019
Maltese: Signifor 30 mg trab u solvent għal suspensjoni għall-injezzjoni EU/1/12/753/019
English: The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Signifor fit-tfal u fl-adoloxxenti minn età 0 sa 18-il sena ma ġewx determinati s'issa.
English: Signifor 30 mg powder for injection pasireotide
Maltese: Signifor 30 mg trab għall-injezzjoni pasireotide
English: Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Signifor intramuscular use 60 mg
Maltese: Signifor użu għal ġolmuskoli 60 mg
English: The proportion of patients with a reduction or no change in pituitary tumour volume at week 24 was 81.0% and 70.3% on pasireotide intramuscular use 40 and 60 mg, and 50.0% on active control.
Maltese: 0% u 70.3% b'40 u 60 mg pasireotide użu għal ġol-muskoli, u ta' 50.0% bil-kontroll talattiv.
English: In a clinical study of a single subcutaneous dose of pasireotide in subjects with impaired hepatic function, statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Maltese: Fi studju kliniku ta' doża waħda ta' pasireotide mogħtija minn taħt il-ġilda f'pazjenti b'indeboliment fil-funzjoni tal-fwied, instabu differenzi klinikament qawwija f'pazjenti b'indeboliment tal-fwied moderat u gravi (Child-Pugh B u C).
English: Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products (e.g. metformin, liraglutide, vildagliptin, nateglinide) may be required when administered concomitantly with pasireotide (see also section 4.4).
Maltese: Jista' jkun hemm bżonn ta' aġġustament tad-doża (tnaqqis jew żieda) tal-insulina u ta' prodotti (eż. metformin, liraglutide, vildagliptin, nateglinide) mediċinali antidijabetiċi meta jingħataw flimkien ma' pasireotide (ara wkoll sezzjoni 4.4).
English: Distribution between blood cells and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%).
Maltese: Id-distribuzzjoni bejn iċ-ċelluli tad-demm u l-plażma hi indipendenti millkonċentrazzjoni u turi li pasireotide hu primarjament lokalizzat fil-plażma (91%).
English: Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived.
Maltese: Pazjenti li jesperjenzaw tnaqqis qawwi fil-livelli tal-kortisol liberu urinarju (UFC) għandhom ikomplu jirċievu Signifor sakemm jibqa' jkun ta' benefiċċju għalihom.
English: Powder and solvent for suspension for injection
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni
English: The responder rate at month 12 was comparable to month 6, with 13.4% and 25.0% in the 0.6 mg and 0.9 mg twice-daily groups, respectively.
Maltese: 0% fil-gruppi mogħtija 0.6 mg u 0.9 mg darbtejn kuljum, rispettivament.
English: Signifor 10 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 10 mg trab u solvent għal suspensjoni għall-injezzjoni pasireotide
English: The safety profile of pasireotide intramuscular use is consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Maltese: Il-profil ta' sigurtà ta' pasireotide użu għal ġol-muskoli kien konsistenti mal-klassi tal-analogi ta' somatostatin, ħlief għall-ogħla grad u frekwenza ta' ipergliċemija murija b'pasireotide użu għal ġolmuskoli.
English: Therapy with pasireotide should be discontinued if the patient develops jaundice or other signs suggestive of clinically significant liver dysfunction, in the event of a sustained increase in AST (aspartate aminotransferase) or ALT of 5 x ULN or greater, or if ALT or AST elevations greater than 3 x ULN occur concurrently with bilirubin elevations greater than 2 x ULN.
Maltese: Għandha titwaqqaf it-terapija b'pasireotide jekk il-pazjent jiżviluppa s-suffejra jew sinjali oħrajn li jissuġġerixxu disfunzjoni klinikament qawwija tal-fwied, f'każ ta' żieda sostenibbli fl-AST (aspartate aminotransferase) jew flALT ta' 5 x ULN jew aktar, jew jekk l-elevazzjonijiet fl-ALT jew l-AST ta' aktar minn 3 x ULN iseħħu fl-istess ħin li l-elevazzjonijiet fil-bilirubin ikunu aktar minn 2 x ULN.
English: Signifor 40 mg is available in unit packs containing one vial of powder with 40 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Maltese: Signifor 40 mg disponibbli f'pakketti b'wieħed li fihom kunjett wieħed bit-trab b'40 mg pasireotide u b'siringa waħda mimlija għal-lest b'2 ml solvent.
English: In the acromegaly studies, the events were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients, and were less frequent in inadequately controlled patients compared to medically naïve patients.
Maltese: F'pazjenti b'akromegalija, disturbi gastrointestinali kienu anqas frekwenti f'pazjenti mhux ikkontrollati kif jixraq imqabblin ma' pazjenti medikament naivi.
English: Your doctor or nurse will inject Signifor.
Maltese: Hemm żewġ stadji kritiċi fir-rikostituzzjoni ta' Signifor.
English: Signifor 0.9 mg solution for injection One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide diaspartate).
Maltese: Signifor 0.9 mg soluzzjoni għall-injezzjoni Ampulla waħda ta' 1 ml fiha 0.9 mg pasireotide (bħala pasireotide diaspartate).
English: The proportion of patients with a reduction of tumour volume greater than 20% at month 12 was 80.8% for pasireotide intramuscular use and 77.4% for octreotide intramuscular use.
Maltese: 8% għal pasireotide użu għal ġol-muskoli u ta' 77.4% għal octreotide użu għal ġol-muskoli.
English: Signifor 0.6 mg solution for injection One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate).
Maltese: Signifor 0.6 mg soluzzjoni għall-injezzjoni Ampulla waħda ta' 1 ml fiha 0.6 mg pasireotide (bħala pasireotide diaspartate).
English: The phase III clinical studies in acromegaly patients did not identify any clinically meaningful differences in the QT prolongation events between pasireotide intramuscular use and the somatostatin analogues which were tested as active comparator.
Maltese: III fost pazjenti b'akromegalija ma identifikawx xi differenzi sinjifikanti klinikament fl-episodji ta' titwil tal-QT bejn pasireotide użu għal ġol-muskoli u l-analogi ta' somatostatin li kienu ttestjati bħala komparatur attiv.
English: Signifor 60 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 60 mg trab u solvent għal suspensjoni għall-injezzjoni pasireotide
English: One vial contains 20 mg pasireotide (as pasireotide pamoate).
Maltese: Kunjett wieħed fih 20 mg pasireotide (bħala pasireotide pamoate).
English: Signifor 10 mg is available in unit packs containing one vial of powder with 10 mg pasireotide and one pre filled syringe with 2 ml solvent.
Maltese: Signifor 10 mg disponibbli f'pakketti b'wieħed li fihom kunjett wieħed bit-trab b'10 mg pasireotide u b'siringa waħda mimlija għal-lest b'2 ml solvent.
English: One vial contains 10 mg pasireotide (as pasireotide pamoate).
Maltese: Kunjett wieħed fih 10 mg pasireotide (bħala pasireotide pamoate).
English: One vial contains 40 mg pasireotide (as pasireotide pamoate).
Maltese: Kunjett wieħed fih 40 mg pasireotide (bħala pasireotide pamoate).
English: The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug interaction study in healthy volunteers.
Maltese: L-influwenza tal-inibitur ta' P-gp verapamil fuq il-farmakokinetika ta' pasireotide taħt il-ġilda kienet ittestjata fi studju dwar l-interazzjoni bejn mediċina u oħra f'voluntiera f'saħħithom.
English: 1 ml solution for injection contains 0.9 mg pasireotide (as pasireotide diaspartate).
Maltese: Soluzzjoni għall-injezzjoni ta' 1 ml fiha 0.9 mg pasireotide (bħala pasireotide diaspartate).
English: In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. Cmax and AUC are approximately dose-proportional following administration of single and multiple doses.
Maltese: F'voluntiera b'saħħithom, pasireotide jiġi assorbit malajr u l-quċċata tal-konċentrazzjoni tal-plażma tintlaħaq fi żmien 0.25-0.5 h.
English: Gamma glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, blood glucose increased, blood amylase increased, prothrombin time prolonged
Maltese: Żieda filgammaglutamiltransfer asi, żieda fl-alanina aminotransferasi, żieda fl-aspartate aminotransferase, żieda fil-lipase, żieda filglukosju fid-demm, żieda fl-amilasi fiddemm, titwil fil-ħin ta' protrombina
English: Signifor 10 mg powder for injection pasireotide
Maltese: Signifor 10 mg trab għall-injezzjoni pasireotide
English: Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of any major enzymes of CYP450.
Maltese: Pasireotide huwa mill-aktar stabbli metabolikament u tagħrif in vitro juri li pasireotide mhuwiex sottostrat, inibitur jew induttur ta' xi enzimi maġġuri ta' CYP450.
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥1/10) waqt fażi
English: Two cases of hyperglycaemia-related emergencies (diabetic ketoacidosis and diabetic hyperglycaemic coma) were reported following a dose increase of pasireotide to 60 mg in medical treatment naïve patients; one in a patient with untreated hyperglycaemia and HbA1c >8% prior to initiation of pasireotide and the other in a patient with untreated hyperglycaemia and a fasting plasma glucose of 359 mg/dl, respectively.
Maltese: Kienu rrappurtati żewġ każijiet ta' emerġenzi relatati ma' ipergliċemija (ketoaċidożi dijabetika u koma kkawżata minn ipergliċemija dijabetika) wara żieda fid-doża ta' pasireotide għal 60 mg f'pazjenti li qatt ma rċevew kura medika qabel; wieħed f'pazjent b'ipergliċemija mhux ikkurata u HbA1cta' > 8% qabel il-bidu ta' pasireotide u l-ieħor f'pazjent b'ipergliċemija mhux ikkurata u livell ta' glucose fil-plażma fi stat sajjem ta' 359 mg/dl, rispettivament.
English: Signifor 30 mg powder and solvent for suspension for injection pasireotide
Maltese: Signifor 30 mg trab u solvent għal suspensjoni għall-injezzjoni pasireotide
English: Population pharmacokinetic analysis suggests that based on Cmax and AUC, 90% of steady state in Cushing's disease patients is reached after approximately 1.5 and 15 days, respectively.
Maltese: Analiżi farmakokinetika talpopolazzjoni tissuġġerixxi li skont is-Cmax u l-AUC, 90% tal-istat wieqaf f'pazjenti morda bil-marda ta' Cushing jintlaħaq wara madwar 1.5 u 15-il jum, rispettivament.
English: Cholelithiasis is a recognised adverse reaction associated with somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Maltese: Il-kolelitijasi hija reazzjoni mhux mixtieqa magħrufa marbuta mal-analogi ta' somatostatin u kienet irrappurtata spiss waqt studji kliniċi b'pasireotide (ara sezzjoni 4.8).
English: Also contains:
Maltese: Sími: