FrancophonIA/ELRC3.0 huggingface dataset:
English: Two doses of teduglutide were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/kg/day (n=26); 9 subjects were enrolled in a standard of care (SOC) arm. Randomisation was stratified by age across dose groups.
Maltese: Żewġ dożi ta' teduglutide kienu studjati: 0.025 mg/kg/jum (n=24) u 0.05 mg/kg/jum (n=26); 9 individwi ġew irreġistrati f'fergħa tal-istandard tal-kura (standard of care, SOC). Il-każwalità kienet stratifikata skont l-età fil-gruppi tad-doża.
English: Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 1.25 mg teduglutide.
Maltese: Kunjett ta' 3 mg b'tapp tal-lastku (bromobutyl) li fih 1.25 mg ta' teduglutide.
English: Since teduglutide is a peptide it is likely that it follows the principal mechanism for peptide metabolism.
Maltese: Peress li teduglutide hu peptide, huwa probabbli li jsegwi l-mekkaniżmu prinċipali għall-metaboliżmu ta' peptidi.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Maltese: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
English: Despite the limited sample size, which did not allow meaningful statistical comparisons, clinically meaningful, numerical reductions in the requirement for parenteral support were observed across all age groups.
Maltese: Minkejja d-daqs limitat tal-kampjun, li ma ppermettix tqabbil statistiku sinifikanti, kien osservat tnaqqis numeriku klinikament sinifikanti filħtieġa għal għajnuna mill-ġenituri fil-gruppi kollha ta' etajiet.
English: Includes the following preferred terms: Pancreatitis, Pancreatitis acute, and Pancreatitis chronic.
Maltese: Pankreatite, Pankreatite akuta u Pankreatite kronika.
English: Based on integrated data from two trials in adults with SBS (a 6-month randomised placebo-controlled trial, followed by a 24-month open-label trial), the development of anti-teduglutide antibodies in subjects who received subcutaneous administration of 0.05 mg/kg teduglutide once daily was 3% (2/60) at Month 3, 17% (13/77) at Month 6, 24% (16/67) at Month 12, 33% (11/33) at Month 24, and 48% (14/29) at Month 30.
Maltese: Ibbażat fuq dejta integrata minn żewġ provi fl-adulti b'SBS (studju li dam 6 xhur, ikkontrollat bi plaċebo, li fih ilparteċipanti ntgħażlu b'mod każwali, segwit minn studju open-label li dam 24 xahar), l-iżvilupp ta' antikorpi anti-teduglutide f'individwi li rċivew għoti taħt il-ġilda ta' 0.05 mg/kg ta' teduglutide darba kuljum kien ta' 3% (2/60) f'Xahar 3, 17% (13/77) f'Xahar 6, 24% (16/67) f'Xahar 12, 33% (11/33) f'Xahar 24, u 48% (14/29) f'Xahar 30.
English: Two (2) patients on the recommended teduglutide dose were weaned off parenteral nutrition by Week 24.
Maltese: Żewġ (2) pazjenti fuq id-doża rrakkomandata ta' teduglutide infatmu min-nutrizzjoni parenterali sa Ġimgħa 24.
English: Following subcutaneous administration, similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling.
Maltese: Wara l-għoti taħt il-ġilda, Cmax simili ta' teduglutide fil-gruppi kollha ta' età, intwera minn immudellar farmakokinetiku tal-popolazzjoni.
English: The proportion of teduglutide-treated subjects achieving a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different from placebo (27 out of 43 subjects, 62.8% versus 13 out of 43 patients, 30.2%, p=0.002).
Maltese: Il-proporzjon ta' individwi ttrattati b'teduglutide li kisbu tnaqqis minn 20% sa 100% ta' nutrizzjoni parenterali f'Ġimgħa 20 u 24, kien differenti b'mod statistikament sinifikanti mill-plaċebo (27 minn 43 individwu, 62.8% kontra 13 minn 43 pazjent, 30.2%, p=0.002).
English: At the end of study, 3 (50%), 2 (33%) and 2 (33%) achieved a reduction of 1, 2, or 3 days per week in parenteral nutrition, respectively.
Maltese: Fi tmiem l-istudju, 3 (50%), 2 (33%) u 2 (335) kisbu tnaqqis ta' 1, 2 jew 3 ijiem fil-ġimgħa fin-nutrizzjoni parenterali, rispettivament.
English: At the end of study, 14 (48.3%), 7 (24.1%) and 5 (17.2%) patients achieved a reduction of 1, 2, or 3 days per week in parenteral nutrition, respectively.
Maltese: Fi tmien l-istudju, 14 (48.3%), 7 (24.1%) u 5 (17.2%) tal-pazjenti kisbu tnaqqis ta' 1, 2, jew 3 ijiem fil-ġimgħa finnutrizzjoni parenterali, rispettivament.
English: Unopened vials 4 years.
Maltese: Kunjetti mhux miftuħa 4 snin.
English: Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications.
Maltese: Madwar 38% tal-pazjenti ttrattati bi stoma esperjenzaw kumplikazzjonijiet gastrointestinali marbuta ma' stoma.
English: Fluid overload has been observed in clinical trials.
Maltese: Fluwidu eċċessiv ġie osservat fil-provi kliniċi.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate
Maltese: Disodium phosphate heptahydrate
English: The mean change in parenteral nutrition volume from baseline at Week 24, based on subject diary data, was -23.30 (±17.50) mL/kg/day, corresponding to -41.57% (±28.90); the mean change in the SOC arm was -6.03 (±4.5) mL/kg/day (corresponding to a -10.21% [±13.59]).
Maltese: Il-bidla medja fil-volum ta' nutrizzjoni parenterali mil-linja bażi f'Ġimgħa 24, abbażi tad-dejta mid-djarju tal-individwi, kienet ta' -23.30 (±17.50) mL/kg/jum, li tikkorrispondi għal -41.57% (±28.90); il-bidla medja fil-fergħa SOC kienet ta' -6.03 (±4.5) mL/kg/jum (li tikkorrispondi għal -10.21% [±13.59]).
English: Overall, the safety profile of teduglutide (including type and frequency of adverse reactions, and immunogenicity) in children and adolescents (ages 1-17 years) was similar to that in adults.
Maltese: B'mod globali, il-profil tas-sigurtà ta' teduglutide (inkluż it-tip u lfrekwenza ta' reazzjonijiet avversi, u l-immunoġeneċità) fi tfal u adolexxenti (etajiet ta' 1-17-il sena) kien simili għal dak fl-adulti.
English: However, lower exposure (AUC) and shorter half-life were seen in paediatric patients 1 to 17 years of age, as compared with adults.
Maltese: Madankollu, esponiment iktar baxx (AUC) u half-life iqsar ġew osservati f'pazjenti pedjatriċi li kellhom minn 1 sa 17-il sena, meta mqabbla mal-adulti.
English: Duodenal polyp
Maltese: Polipi fidduwodenu
English: Materials needed but not included in the pack: - Reconstitution needles (size 22G, length 1½" (0.7 x 40 mm)) - 0.5 or 1 ml injection syringes (with scale intervals of 0.02 ml or smaller).
Maltese: Materjali meħtieġa li mhumiex inklużi fil-pakkett: - Labar ta' rikostituzzjoni (daqs 22G, tul 1½" (0.7 x 40 mm)) - Siringi tal-injezzjoni ta' 0.5 ml jew 1 ml (b'intervalli ta' skala ta' 0.02 ml jew inqas).
English: Animal data do not indicate any impairment of fertility.
Maltese: Dejta mill-annimali ma tindikax indeboliment għal fertilita.
English: EU/1/12/787/002 1 vial EU/1/12/787/001 28 vials
Maltese: EU/1/12/787/002 1 kunjett EU/1/12/787/001 28 kunjett
English: One vial of powder contains 1.25 mg of teduglutide.
Maltese: Kunjett wieħed ta' trab fih 1.25 mg ta' teduglutide.
English: Other medicines and Revestive
Maltese: Mediċini oħra u Revestive
English: No data are available for paediatric patients with moderate to severe renal impairment and end-stage renal disease (ESRD).
Maltese: L-ebda dejta mhi disponibbli għal pazjenti pedjatriċi b'indeboliment moderat sa sever tal-kliewi u mard renali tal-aħħar stadju (end stage renal disease (ESRD)).
English: Reduction in parenteral nutrition volume
Maltese: Tnaqqis fil-volum tan-nutrizzjoni parenterali
English: Teduglutide increases villus height and crypt depth of the intestinal epithelium.
Maltese: Teduglutide iżid it-tul tal-villus u l-fond tal-kripta tal-epitelju intestinali.
English: Teduglutide was studied in a 12-week, open-label, clinical study in 42 paediatric subjects aged 1 year through 14 years with SBS who were dependent on parenteral nutrition.
Maltese: Teduglutide ġie studjat fi studju kliniku li dam 12-il ġimgħa, open-label, li sar fuq 42 individwu pedjatriku li kellhom minn sena sa 14-il sena b'SBS li kienu dipendenti fuq nutrizzjoni parenterali.
English: Sixteen (16, 55.2%) of the 29 completers achieved a 20% or greater reduction of parenteral nutrition.
Maltese: Sittax (16, 55.2%) minn 29 li lestew l-istudju kisbu tnaqqis ta' 20% jew akbar ta' nutrizzjoni parenterali.
English: Teduglutide was studied in 17 patients with SBS allocated to five treatment groups using doses of 0.03, 0.10 or 0.15 mg/kg teduglutide once daily, or 0.05 or 0.075 mg/kg bid in a 21-day open-label, multicenter, dose-ranging study.
Maltese: Teduglutide ġie studjat fi 17-il pazjent b'SBS li ġew allokati f'ħames gruppi ta' trattament li kienu jużaw dożi ta' 0.03, 0.10 jew 0.15 mg/kg ta' teduglutide darba kuljum, jew 0.05 jew 0.075 mg/kg darbtejn kuljum (bid) fi studju multiċentriku, open-label u fuq firxa ta' dożi għal 21 jum.
English: Adenomas of the jejunal mucosa were observed in 1 out of 50 males and 5 out of 50 males exposed to teduglutide plasma levels approximately 10- and 155-fold higher than obtained in patients administered the recommended daily dose.
Maltese: Adenomi tal-mukoża ġeġunali kienu osservati f'1 minn 50 raġel u f'5 minn 50 raġel esposti għal-livelli ta' teduglutide fil-plażma ta' madwar 10 u 155 darba ogħla minn dawk miksuba f'pazjenti mogħtija d-doża rakkomandata ta' kuljum.
English: The mean reduction in parenteral nutrition was 4.0 l/week (39.4% reduction from baseline - the start of the extension study) and 4 of the 6 completers (66.7%) achieved a 20% or greater reduction in parenteral support.
Maltese: It-tnaqqis medju fin-nutrizzjoni parenterali kien ta' 4.0 l/ġimgħa (tnaqqis ta' 39.4% millinja bażi - il-bidu tal-istudju ta' estensjoni) u 4 minn 6 li lestew (66.7%) kisbu tnaqqis ta' 20% jew aktar fis-appoġġ parenterali.
English: Decreased appetite Fluid overload
Maltese: Tnaqqis fl-aptit Fluwidu eċċessiv
English: Similar to GLP-2, teduglutide is 33 amino acids in length with an amino acid substitution of alanine by glycine at the second position of the N-terminus.
Maltese: Bħal GLP-2, teduglutide jikkonsisti minn tul ta' 33 aċidu amminiku b'sostituzzjoni ta' aċidu amminiku ta' alanine minn glycine fit-tieni pożizzjoni tat-terminu-N.
English: The absolute bioavailability of subcutaneous teduglutide is high (88%).
Maltese: Il-bijodisponibilità assoluta ta' teduglutide li jingħata taħt il-ġilda hija għolja (88%).
English: Gastrointestinal stoma complication
Maltese: Kumplikazzjoni talistoma gastrointestinali
English: Revestive has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years (see section 4.3).
Maltese: Revestive ma ġiex studjat f'pazjenti li jkollhom mard fl-istess ħin li jkun sever u klinikament instabbli, (eż., kardjovaskulari, respiratorji, renali, infezzjonijiet, endokrinali, fwied, jew SNĊ), jew f'pazjenti b'tumuri malinni fl-aħħar ħames snin (ara sezzjoni 4.3).
English: However, cases of syncope have been reported in clinical studies (see section 4.8).
Maltese: Madankollu, każijiet ta' sinkope ġew irrappurtati fi studji kliniċi (ara sezzjoni 4.8).
English: At Week 12, based on subject diary data, subjects showed mean percentage reductions of 35.55% (±35.23) hours per day compared to baseline, which corresponded to reductions in the hours/day of parenteral nutrition usage of -4.18 (±4.08), while subjects in the standard of care cohort showed minimal change in this parameter at the same time point.
Maltese: F'Ġimgħa 12, ibbażat fuq dejta mid-djarji tal-individwi, l-individwi wrew tnaqqis perċentwali medju ta' 35.55% (±35.23) siegħa kuljum meta mqabbla mal-linja bażi, li kien jikkorrispondi għal tnaqqis fissigħat/jum tal-użu tan-nutrizzjoni parenterali ta' -4.18 (±4.08), filwaqt l-individwi fil-koorti ta' standard ta' kura, urew bidla minima f'dan il-parametru fl-istess punt ta' żmien.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS).
Maltese: Revestive huwa indikat għat-trattament ta' pazjenti li jkollhom sena jew aktar bis-Sindrome tal-Musrana ż-Żgħira (Short Bowel Syndrome, SBS).
English: The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p<0.01).
Maltese: L-analiżi tal-effikaċja primarja tar-riżultati tal-istudju ma wriet l-ebda differenza statistikament sinifikanti bejn il-grupp li kien qiegħed fuq 0.10 mg/kg/jum ta' teduglutide u l-grupp tal-plaċebo, filwaqt li l-proporzjon ta' individwi li kienu qed jirċievu d-doża rakkomandata ta' 0.05 mg/kg/jum ta' teduglutide li kisbu mill-inqas tnaqqis ta' 20% fin-nutrizzjoni parenterali f'Ġimgħa 20 u 24, kienu differenti b'mod statistikament sinifikanti meta mqabbla mal-plaċebo (46% kontra 6.3%, p<0.01).
English: Common (may affect up to 1 in 10 people): - Congestive heart failure.
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Insuffiċjenza konġestiva tal-qalb.
English: At Week 16 (4 weeks following the end of treatment) parenteral nutrition volume reductions were still evident but less than observed at Week 12 when subjects were still on teduglutide (mean decrease of -31.80% (±39.26) compared to a 3.92% (±16.62) increase in the standard of care group).
Maltese: F'Ġimgħa 16 (4 ġimgħat wara t-tmiem tal-kura) ittnaqqis fil-volum tan-nutrizzjoni parenterali kien għadu evidenti, iżda inqas minn dak osservat f'Ġimgħa 12 meta l-individwi kienu għadhom fuq teduglutide (medja ta' tnaqqis ta' -31.80% (±39.26) meta mqabbla ma' żieda ta' 3.92% (±16.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
English: Cases of intestinal obstruction have been reported in clinical studies.
Maltese: Każijiet ta' ostruzzjoni intestinali ġew irrappurtati fi studji kliniċi.
English: In phase 3 studies with SBS patients who received teduglutide for ≥2 years, 28% of patients developed antibodies against E. coli protein (residual host cell protein from the manufacture).
Maltese: Fi studji ta' fażi 3 f'pazjenti b'SBS li rċivew teduglutide għal ≥ sentejn, 28% tal-pazjenti żviluppaw antikorpi kontra l-proteina ta' E. coli (proteina residwa miċ-ċellula ospitanti mill-manifattura).
English: One additional patient in the follow-up study was weaned off parenteral nutrition.
Maltese: Pazjent addizzjonali ieħor fl-istudju follow-up infatam min-nutrizzjoni parenterali.
English: Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Maltese: Materjali pprovduti fil-pakkett: - 28 kunjett b'1.25 mg ta' teduglutide bħala trab - 28 siringa mimlija għal-lest b'solvent
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA (ĊI) ATTIVA(I)
English: Three (3) paediatric subjects in the 0.05 mg/kg group achieved the additional endpoint of enteral autonomy by week 24.
Maltese: Tliet (3) individwi pedjatriċi fil-grupp ta' 0.05 mg/kg kisbu l-punt ta' tmiem addizzjonali ta' awtonomija enterali sa ġimgħa 24.
English: Treatment with teduglutide resulted in a 4.4 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 12.9 litres) versus 2.3 l/week (from a pre-treatment baseline of 13.2 litres) for placebo at 24 weeks.
Maltese: It-trattament b'teduglutide irriżulta fi tnaqqis ta' 4.4 l/ġimgħa fir-rekwiżiti ta' nutrizzjoni parenterali (minn linja bażi ta' qabel it-trattament ta' 12.9 litri) kontra 2.3 l/ġimgħa (minn linja bażi qabel it-trattament ta' 13.2 litri) għal plaċebo wara 24 ġimgħa.
English: 3.6 Check for air bubbles.
Maltese: 3.6 Iċċekkja għal bżieżaq tal-arja.
English: Colo-rectal polyps
Maltese: Polipi kolorettali
English: Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies.
Maltese: B'mod konsistenti mal-karatteristiċi potenzjalment immunoġeniċi ta' prodotti mediċinali li fihom il-peptidi, l-għoti ta' Revestive jista' potenzjalment jikkawża l-iżvilupp ta' antikorpi.
English: The maximum dose of teduglutide studied during clinical development was 86 mg/day for 8 days.
Maltese: Id-doża massima ta' teduglutide studjata matul l-iżvilupp kliniku kienet ta' 86 mg/jum għal 8 ijiem.
English: Of the patients who achieved at least a 20% reduction of parenteral nutrition at Weeks 20 and 24 in the initial study, 75% sustained this response on teduglutide after up to 1 year of continuous treatment.
Maltese: Mill-pazjenti li kisbu mill-inqas tnaqqis ta' 20% ta' nutrizzjoni parenterali f'Ġimgħat 20 u 24 fl-istudju inizjali, 75% żammew dan ir-rispons fuq teduglutide wara sa sena ta' trattament kontinwu.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Maltese: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH).
English: Following subcutaneous administration, teduglutide has an apparent volume of distribution of 26 litres in patients with SBS.
Maltese: Wara l-għoti taħt il-ġilda, teduglutide għandu volum apparenti ta' distribuzzjoni ta' 26 litru f'pazjenti b'SBS.
English: In another phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, patients received a 0.05 mg/kg/day dose (n=35), a 0.10 mg/kg/day dose (n=32) of teduglutide or placebo (n=16) for up to 24 weeks.
Maltese: Fi studju ieħor ta' fażi 3, double-blind, ikkontrollat bi plaċebo li sar fuq pazjenti b'SBS, li kienu jeħtieġu nutrizzjoni parenterali, il-pazjenti rċivew doża ta' 0.05 mg/kg/jum (n=35), doża ta' 0.10 mg/kg/jum (n=32) ta' teduglutide jew plaċebo (n=16) għal sa 24 ġimgħa.
English: Gender No clinically relevant gender differences were observed in clinical studies.
Maltese: Sess tal-persuna L-ebda differenzi klinikament rilevanti bejn is-sessi ma kienu osservati fi studji kliniċi.
English: With progressive renal impairment up to and including end-stage renal disease the primary pharmacokinetic parameters of teduglutide increased up to a factor of 2.6 (AUCinf) and 2.1 (Cmax) compared to healthy subjects.
Maltese: B'indeboliment renali progressiv, sa u li jinkludi l-mard renali tal-aħħar stadju, il-parametri farmakokinetiċi primarji ta' teduglutide żdiedu sa fattur ta' (AUCinf) ta' 2.6 u (Cmax) ta' 2.1 meta mqabbla ma' individwi b'saħħithom.
English: Reproductive and developmental toxicity studies evaluating teduglutide have been carried out in rats and rabbits at doses of 0, 2, 10 and 50 mg/kg/day subcutaneously.
Maltese: Studji dwar tossiċità riporduttiva u tal-iżvilupp li jevalwaw teduglutide saru fuq firien u fniek f'dożi ta' 0, 2, 10 u 50 mg/kg/jum taħt il-ġilda.
English: At Week 16, the parenteral nutrition calories consumption continued to decrease with percentage mean changes from baseline of -39.15% (±39.08) compared to -0.87% (±9.25) for the standard of care cohort.
Maltese: F'Ġimgħa 16, ilkonsum tal-kaloriji tan-nutrizzjoni parenterali kompla jonqos, b'bidliet medji perċentwali mil-linja bażi ta' -39.15% (±39.08) meta mqabbla ma' -0.87% (±9.25) għall-koorti ta' standard ta' kura.
English: In the pivotal phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, 43 patients were randomised to a 0.05 mg/kg/day dose of teduglutide and 43 patients to placebo for up to 24 weeks.
Maltese: Fl-istudju ewlieni ta' fażi 3, double-blind, ikkontrollat bi plaċebo li sar fuq pazjenti b'SBS, li kienu jeħtieġu nutrizzjoni parenterali, 43 pazjent ġew magħżula b'mod każwali għal doża ta' 0.05 mg/kg/jum ta' teduglutide u 43 pazjent għal plaċebo għal sa 24 ġimgħa.
English: At the end of study, 21 (70%), 18 (60%) and 18 (60%) of the 30 completers achieved a reduction of 1, 2, or 3 days per week in parenteral support, respectively.
Maltese: Fi tmiem l-istudju, 21 (70%), 18 (60%) u 18 (60%) tat-30 persuna li lestew listudju, kisbu tnaqqis ta' 1, 2 jew 3 ijiem fil-ġimgħa fl-appoġġ parenterali, rispettivament.
English: Hyperplasia in the gall bladder, hepatic biliary ducts, and pancreatic ducts were observed in subchronic and chronic toxicology studies.
Maltese: L-iperplasija fil-bużżieqa tal-marrara, tubi biljari epatiċi, u tubi tal-frixa, ġiet osservata fi studji tossikoloġiċi subkroniċi u kroniċi.
English: Patients should be stable following a period of intestinal adaptation after surgery.
Maltese: Il-pazjenti għandhom ikunu stabbli wara perjodu t'adattament intestinali wara l-kirurġija.
English: Pack size of 28 vials of powder with 28 pre-filled syringes.
Maltese: Daqs tal-pakkett ta' 28 kunjett bit-trab bi 28 siringa mimlija lesta.
English: The mean reduction of weekly parenteral nutrition volume was 4.9 l/week (52% reduction from baseline) after one year of continuous teduglutide treatment.
Maltese: It-tnaqqis medju tal-volum nutrizzjonali parenterali ta' kull ġimgħa kien ta' 4.9 l/ġimgħa (tnaqqis ta' 52% mil-linja bażi) wara sena ta' trattament kontinwu b'teduglutide.
English: In a rat carcinogenicity study, treatment related benign neoplasms included tumours of the bile duct epithelium in males exposed to teduglutide plasma levels approximately 32- and 155-fold higher than obtained in patients administered the recommended daily dose (incidence of 1 out of 44 and 4 out of 48, respectively).
Maltese: Fi studju dwar il-karċinoġeniċità fil-firien, neoplażmi beninni relatati mat-trattament kienu jinkludu tumuri fl-epitilju tal-kanal biljari f'firien irġiel esposti għal-livelli ta' teduglutide fil-plażma li kienu madwar 32 u 155 darba ogħla minn dawk miksuba f'pazjenti mogħtija d-doża rakkomandata ta' kuljum (inċidenza ta' 1 minn 44 u 4 minn 48, rispettivament).
English: Teduglutide was rapidly absorbed from subcutaneous injection sites with maximum plasma levels occurring approximately 3-5 hours after dose administration at all dose levels.
Maltese: Teduglutide kien assorbit malajr minn siti tal-injezzjoni taħt il-ġilda b'livelli massimi fil-plażma jseħħu bejn wieħed u ieħor 3-5 sigħat wara l-għoti tad-doża fil-livelli kollha tad-doża.
English: As a precautionary measure it is preferable to avoid the use of Revestive during breast-feeding.
Maltese: B'mod ġenerali, fluwidu eċċessiv jista' jiġi evitat permezz ta' valutazzjoni xierqa u f'waqtha tal-bżonnijiet nutrizzjonali parenterali.
English: In a phase 1 study no difference in pharmacokinetics of teduglutide could be detected between healthy subjects younger than 65 years versus older than 65 years.
Maltese: Fi studju ta' fażi 1, ma ġiet osservata l-ebda differenza fil-farmakokinetika ta' teduglutide bejn individwi b'saħħithom iżgħar minn 65 sena meta mqabbla ma' dawk li kellhom 'il fuq minn 65 sena.