FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on subject diary data, 18 (69.2%) subjects in the 0.05 mg/kg/day group achieved the primary endpoint of ≥20% reduction in PN/IV volume at end of treatment, compared to baseline; in the SOC arm, 1 (11.1%) subject achieved this endpoint.
Maltese: Fuq il-bażi tad-dejta mid-djarju tal-individwi, 18-il individwu (69.2%) fil-grupp ta' 0.05 mg/kg/jum kisbu l-punt tat-tmiem primarju ta' tnaqqis ta' ≥20% fil-volum ta' PN/IV fit-tmiem tal-kura, meta mqabbel mallinja bażi; fil-fergħa SOC, individwu 1 (11.1%) kiseb dan il-punt ta' tmiem.
English: The mean decrease from baseline at Week 24 in the number of days/week on parenteral nutrition, based on subject diary data, was -1.34 (±2.24) days/week corresponding to a percentage decrease of -21.33% (±34.09).
Maltese: It-tnaqqis medju mil-linja bażi f'Ġimgħa 24 fin-numru ta' jiem/ġimgħa fuq nutrizzjoni parenterali, abbażi tad-dejta mid-djarju tal-individwi, kien ta' -1.34 (±2.24) jiem/ġimgħa, li jikkorrispondi għal tnaqqis perċentwali ta' -21.33% (±34.09).
English: Five (5) subjects were enrolled in a standard of care cohort.
Maltese: Ħames (5) individwi ġew irreġistrati f'koorti ta' standard ta' kura.
English: Based on the findings derived from pre-clinical studies (see sections 4.4 and 5.3) and the proposed mechanism of action with the trophic effects on intestinal mucosa, there appears to be a risk for the promotion of small intestinal and/or colonic neoplasia.
Maltese: Abbażi fuq is-sejbiet li joħorġu mill-istudji ta' qabel l-użu kliniku (ara sezzjonijiet 4.4 u 5.3) u lmekkaniżmu ta' azzjoni propost mal-effetti trofiċi fuq il-mukoża intestinali, jidher li hemm riskju għallpromozzjoni ta' neoplażija fil-musrana ż-żgħira u/jew fil-kolon.
English: Revestive contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Revestive fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: An in vitro study indicates that teduglutide does not inhibit cytochrome P450 drug metabolising enzymes.
Maltese: Studju in vitro jindika li teduglutide ma jimpedixxix l-enzimi metaboliċi f'mediċini ta' ċitokrom P450.
English: There are no data available in paediatric patients after 6 months (see section 5.1).
Maltese: M'hemmx data disponibbli f'pazjenti pedjatriċi wara 6 xhur (ara sezzjoni 5.1).
English: Revestive is a powder and solvent for solution for injection (1.25 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Maltese: Revestive huwa trab u solvent għal soluzzjoni għall-injezzjoni (1.25 mg ta' teduglutide f'kunjett, 0.5 ml ta' solvent f'siringa mimlija għal-lest).
English: Four subjects (26.7%) on the recommended teduglutide dose achieved at least a three-day reduction in parenteral nutrition needs.
Maltese: Erba' individwi (26.7%) fuq id-doża rakkomandata ta' teduglutide kisbu mill-inqas tnaqqis ta' tlett ijiem fir-rekwiżiti tan-nutrizzjoni parenterali.
English: At week 24, there was a decrease in the infusion time of -3.03 (±3.84) hours/day in the 0.05 mg/kg/day arm, corresponding to a percentage change of -26.09% (±36.14).
Maltese: F'ġimgħa 24 kien hemm tnaqqis fil-ħin tal-infużjoni ta' -3.03 (±3.84) sigħat/jum fil-fergħa ta' 0.05 mg/kg/jum, li tikkorrispondi għal tibdil perċentwali ta' -26.
English: Use in children and adolescents
Maltese: Għat-tfal u adolexxenti
English: In paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section 5.2).
Maltese: F'pazjenti tfal b'indeboliment renali moderat u sever (tneħħija tal-kreatinina inqas minn 50 ml/min), u fl-aħħar stadju ta' mard renali, id-doża ta' kuljum għandha titnaqqas b'50% (ara sezzjoni 5.2).
English: Of these, 28 patients (93%) achieved a 20% or greater reduction of parenteral support.
Maltese: Minn dawn, 28 pazjent (93%) kisbu tnaqqis ta' 20% jew aktar ta' appoġġ parenterali.
English: At Week 12, there was a -35.11% (±53.04) mean change from baseline in parenteral nutrition calorie consumption in the ITT population based on physician-prescribed data.
Maltese: 11% (±53.04) mil-linja bażi fil-konsum ta' kaloriji tannutrizzjoni parenterali fil-popolazzjoni ITT, ibbażata fuq dejta minn kura mogħtija b'riċetta mit-tabib.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: struzzjonijiet għall-preparazzjoni u l-injettar ta' Revestive Informazzjoni importanti:
English: Colorectal polyp Colonic stenosis Flatulence Intestinal obstruction Pancreatic duct stenosis
Maltese: Stenożi fil-kolon Gass fl-istonku Ostruzzjoni fl-imsaren Stenożi fil-passaġġ talfrixa Pankreatite
English: Revestive 1.25 mg powder for solution for injection teduglutide
Maltese: Revestive 1.25 mg trab għal soluzzjoni għall-injezzjoni teduglutide
English: Teduglutide has a terminal elimination half-life of approximately 2 hours.
Maltese: Teduglutide għandu half-life terminali ta' madwar sagħtejn.
English: Pharmacokinetics in subpopulations
Maltese: Farmakokinetika f'sottopopolazzjonijiet
English: Based upon the pharmacodynamic effect of teduglutide, there is a potential for increased absorption of concomitant medicinal products (see section 4.4).
Maltese: Ibbażat fuq l-effett farmakodinamiku ta' teduglutide, hemm potenzjal għal żieda fl-assorbiment ogħla ta' prodotti mediċinali mogħtija fl-istess ħin (ara sezzjoni 4.4).
English: SOLVENT PREFILLED SYRINGE LABEL
Maltese: żomm is-siringa kif iżżomm lapes.
English: No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of teduglutide for up to 30 months in a long-term open-label extension study.
Maltese: Ma ġewx identifikati sinjali ta' sigurtà ġodda f'pazjenti esposti għal 0.05 mg/kg/jum ta' teduglutide għal sa 30 xahar fi studju fuq perjodu ta' żmien twil open-label.
English: An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on parenteral support.
Maltese: Studju multiċentriku addizzjonali li fih il-parteċipanti ntgħażlu b'mod każwali u double-blind, ta' 24 ġimgħa twettaq fuq 59 individwu pedjatriku li kellhom bejn l-età ta' sena u 17-il sena li kienu dipendenti fuq appoġġ parenterali.
English: The maximum exposure and the overall extent of exposure to teduglutide following single 20 mg subcutaneous doses were lower (10-15%) in subjects with moderate hepatic impairment relative to those in healthy matched controls.
Maltese: L-esponiment massimu u l-firxa globali ta' esponiment għal teduglutide wara dożi waħidhom ta' 20 mg ta' teduglutide taħt il-ġilda kienu iktar baxxi (10-15%) f'individwi b'indeboliment epatiku moderat meta pparagunati ma' dawk b'saħħithom fil-kontrolli mqabbla.
English: Ninety-seven percent (97%) of patients (37 out of 39 patients treated with teduglutide) that completed the placebo-controlled study entered a long-term extension study where all patients received 0.05 mg/kg of Revestive daily for up to an additional 2 years.
Maltese: Sebgħa u disgħin fil-mija (97%) tal-pazjenti (37 minn 39 pazjent ikkurati b'teduglutide) li temmew listudju kkontrollat bil-plaċebo, daħlu fi studju ta' estensjoni fuq perjodu ta' żmien twil fejn il-pazjenti kollha rċivew 0.05 mg/kg ta' Revestive kuljum għal sa sentejn oħra.
English: The naturally occurring human glucagon-like peptide-2 (GLP-2) is a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility.
Maltese: Peptide-2 (GLP-2) li tixbah lil glucagon, li sseħħ b'mod naturali fil-bniedem, huwa peptid li jitnixxa minn ċelluli L tal-imsaren li hu magħruf li jżid l-influss intestinali u portali tad-demm, jimpedixxi t-tnixxija ta' aċidu gastriku u jnaqqas il-motilità intestinali.
English: Powder and solvent for solution for injection 1 vial of powder containing 5 mg teduglutide 1 pre-filled syringe containing 0.5 ml of solvent 28 vials of powder containing 5 mg teduglutide 28 pre-filled syringes containing 0.5 ml of solvent
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni 1 kunjett ta' trab li fih 5 mg ta' teduglutide 1 siringa mimlija għal-lest li fiha 0.5 ml ta' solvent 28 kunjett ta' trab li fihom 5 mg ta' teduglutide 28 siringa mimlija għal-lest li fihom 0.5 ml ta' solvent
English: In a phase 1 study the effect of hepatic impairment on the pharmacokinetics of teduglutide following subcutaneous administration of 20 mg teduglutide was investigated.
Maltese: Fi studju ta' fażi 1, l-effett ta' indeboliment epatiku fuq il-farmakokinetika ta' teduglutide wara l-għoti ta' teduglutide 20 mg taħt il-ġilda ġiet mistħarrġa.
English: Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your large bowel - Passing gas (flatulence) - Narrowing or blockage of your pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni): - Infezzjoni tal-passaġġ respiratorju (kwalunkwe infezzjoni tas-sinus, fil-griżmejn, fil-passaġġi tal arja jew fil-pulmun) - Uġigħ ta' ras - Uġigħ fl-istonku, stonku minfuħ, tħossok ma tiflaħx (dardir), nefħa fl-istoma (ftuħ artifiċjali għat tneħħija tal-ippurgar), rimettar - Ħmura, uġigħ jew nefħa fis-sit tal-injezzjoni
English: In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
Maltese: F'diversi studji mhux kliniċi, intwera li teduglutide jippreserva l-integrità mukożali billi jippromwovi tiswija u tkabbir normali tal-imsaren permezz ta' żieda fit-tul tal-villus u l-fond tal-kripta.
English: Important information:
Maltese: NOTA:
English: The pharmacokinetic profile of Revestive in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights.
Maltese: Il-profil farmakokinetiku ta' teduglutide f'din il-popolazzjoni pedjatrika, kif evalwat mit-tneħħija u l-volum taddistribuzzjoni, kien differenti minn dak osservat fl-adulti wara li ġew ikkoreġuti l-piżijiet tal-ġisem.
English: Revestive is a powder and solvent for solution for injection (5 mg teduglutide in vial, 0.5 ml solvent in pre-filled syringe).
Maltese: Revestive huwa trab u solvent għal soluzzjoni għall-injezzjoni (5 mg ta' teduglutide f'kunjett, 0.5 ml ta' solvent f'siringa mimlija għal-lest).
English: Following intravenous administration teduglutide plasma clearance was approximately 127 ml/hr/kg which is equivalent to the glomerular filtration rate (GFR).
Maltese: Wara l-għoti ġol-vini, it-tneħħija ta' teduglutide fil-plażma kienet ta' madwar 127 ml/siegħa/kg, li huwa ekwivalenti għar-rata tal-filtrazzjoni glomerulari (GFR).
English: Solvent Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Maltese: Solvent Siringa mimlija għal-lest (ħġieġ) bil-planġers (bromobutyl) li fiha 0.5 ml ta' solvent..
English: The recommended daily dose for your child is 0.05 mg per kg body weight.
Maltese: Id-doża rakkomandata ta' Revestive hija ta' 0.05 mg/kg piż tal-ġisem darba kuljum.
English: These studies included 101 patients in the following age groups: 5 patients 1-2 years, 56 patients 2 to <6 years, 32 patients 6 to <12 years, 7 patients 12 to <17 years, and 1 patient 17 to <18 years.
Maltese: Dawn l-istudji kienu jinkudu 101 pazjenti fil-gruppi tal-etajiet li ġejjin: 5 pazjenti kellhom minn sena sa sentejn, 56 pazjent minn sentejn sa <6 snin, 32 pazjent minn 6 sa <12-il sena, 7 pazjenti minn 12 sa <17-il sena, u pazjent wieħed minn 17 sa <18-il sena.
English: Caution is needed when administering Revestive to persons with a known hypersensitivity to tetracycline (see section 4.3).
Maltese: Fil-każ ta' tumuri malinni, it-terapija ta' Revestive trid titwaqqaf (ara sezzjoni 4.3).
English: Revestive 1.25 mg powder and solvent for solution for injection teduglutide
Maltese: Revestive 1.25 mg trab u solvent għal soluzzjoni għall-injezzjoni teduglutide
English: The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of Revestive.
Maltese: Il-formazzjoni ta' antikorpi ma kinitx assoċjata ma' riżultati klinikament rilevanti dwar is-sigurtà, effikaċja mnaqqsa jew farmakokinetika mibdula ta' Revestive.
English: A 1.25 mg strength vial is also available for paediatric use (patients with a body weight <20 kg).
Maltese: Kunjett b'qawwa ta' 1.25 mg hu disponibbli wkoll għal użu pedjatriku (pazjenti b'piż tal-ġisem ta' <20 kg).
English: Sixty-five (65) patients entered a follow-up SBS study for up to an additional 28 weeks of treatment.
Maltese: Ħamsa u sittin (65) pazjent daħlu għal studju follow-up dwar SBS għal sa 28 ġimgħa addizzjonali ta' trattament.
English: Revestive 1.25 mg powder and solvent for solution for injection
Maltese: Revestive 1.25 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Reconstituted product Chemical and physical stability has been demonstrated for 3 hours at 25°C.
Maltese: Prodott rikostitwit L-istabbiltà kimika u fiżika ntweriet għal 3 sigħat f'temperatura ta' 25°C.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 adult patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Maltese: Ir-reazzjonijiet avversi nkisbu minn 2 studji kliniċi bil-plaċebo bħala kontroll b'teduglutide f'109 pazjenti adulti b'SBS kkurati b'dożi ta' 0.05 mg/kg/jum u 0.10 mg/kg/jum sa 24 ġimgħa.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
English: One vial of powder contains 5 mg of teduglutide*.
Maltese: Kunjett wieħed ta' trab fih 5 mg ta' teduglutide*
English: Revestive 5 mg powder for solution for injection teduglutide
Maltese: Revestive 5 mg trab għal soluzzjoni għall-injezzjoni teduglutide
English: It improves the absorption of nutrients and fluid from your child's remaining gastrointestinal tract (gut).
Maltese: Itejjeb l-assorbiment ta' nutrijenti u fluwidu mill-musrana gastrointestinali li jkun fadallek.
English: Revestive 5 mg powder and solvent for solution for injection Teduglutide
Maltese: Revestive 5 mg trab u solvent għal soluzzjoni għall-injezzjoni teduglutide
English: One vial of powder contains 5 mg of teduglutide.
Maltese: Kunjett wieħed ta' trab fih 5 mg ta' teduglutide.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Maltese: Ir-reazzjonijiet avversi nkisbu minn 2 studji kliniċi bil-plaċebo bħala kontroll b'teduglutide f'109 pazjenti b'SBS kkurati b'dożi ta' 0.05 mg/kg/jum u 0.10 mg/kg/jum sa 24 ġimgħa.
English: Treatment with teduglutide resulted in a 2.5 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 9.6 litres) versus 0.9 l/week (from a pre-treatment baseline of 10.7 litres) for placebo at 24 weeks.
Maltese: It-trattament b'teduglutide irriżulta fi tnaqqis ta' 2.5 l/ġimgħa fir-rekwiżiti ta' nutrizzjoni parenterali (minn linja bażi ta' qabel it-trattament ta' 9.6 litri) kontra 0.9 l/ġimgħa (minn linja bażi qabel it-trattament ta' 10.
English: Subsequent colonoscopies are recommended at a minimum of five year intervals.
Maltese: Kolonoskopiji sussegwenti huma rakkomandati li jsiru f'intervalli minimi ta' kull ħames snin.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or trace residues of tetracycline.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1, jew residwi f'ammonti żgħar ta' tetracycline.
English: Pancreatic adverse events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection and increased blood amylase and lipase have been reported in clinical studies.
Maltese: Każijiet ta' reazzjonijiet avversi marbuta mal-frixa bħal pankreatite, stenożi fil-passaġġ pankreatiku, infezzjoni fil-frixa u żieda fl-amylase u lipase fid-demm, ġew irrappurtati fi studji kliniċi.
English: No unexpected systemic adverse reactions were seen (see section 4.8).
Maltese: L-ebda reazzjoni avversa sistemika mhux mistennija ma dehret (ara sezzjoni 4.8).
English: The efficacy data presented are derived from 2 controlled studies in paediatric patients up to 24 weeks duration.
Maltese: Id-data dwar l-effikaċja ppreżentata kienet derivata minn 2 studji kontrollati f'pazjenti pedjatriċi li damu sa 24 ġimgħa.
English: Very common (may affect more than 1 in 10 people): - Respiratory tract infection (any infection of the sinuses, throat, airways or lungs) - Headache - Stomach pain, bloated stomach, feeling sick (nausea), swelling of stoma (an artificial opening for waste removal), vomiting - Reddening, pain or swelling at the site of the injection
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Influwenza jew sintomi bħal tal-influwenza - Nuqqas t'aptit - Nefħa tal-idejn u/jew tas-saqajn - Problemi biex torqod, ansjetà - Sogħla, qtugħ ta' nifs
English: Revestive 5 mg powder and solvent for solution for injection
Maltese: Revestive 5 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Maltese: Ma kienx hemm żidiet medji klinikament rilevanti ta' proteina reattiva Ċ mil-linja bażi wara trattament fuq perjodu ta' żmien twil b'teduglutide għal sa 30 xahar.
English: Pancreatitis Small intestinal stenosis
Maltese: Jekk tinsa tuża Revestive
English: In adult or paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section 5.2).
Maltese: F'pazjenti adulti jew tfal b'indeboliment renali moderat u sever (tneħħija tal-kreatinina inqas minn 50 ml/min), u fl-aħħar stadju ta' mard renali, id-doża ta' kuljum għandha titnaqqas b'50% (ara sezzjoni
English: International Short Bowel Syndrome Registry Non-interventional study (NIS) to gather further safety data, in order to further elucidate the potential and identified risk as outlined in the RMP, based on a CHMP approved protocol.
Maltese: L-għanijiet talistudju kienu biex jiġi evalwat is-sigurtà u t-tollerabilità, u l-effikaċja ta' teduglutide meta mqabbla ma' standard ta' kura.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Maltese: - Is-sustanzi mhux attivi l-oħra huma L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH).
English: These observations were potentially associated with the expected intended pharmacology of teduglutide and were to a varying degree reversible within an 8-13 week recovery period following chronic administration.
Maltese: Dawn l-osservazzjonijiet kienu potenzjalment assoċjati mal-farmakoloġija mistennija maħsuba għal teduglutide, u kienu, sa gradi differenti, riversibbli fi żmien 8-13-il ġimgħa ta' żmien ta' rkupru wara l-għoti kroniku.
English: The mean change in parenteral nutrition volume from baseline at Week 12 in the ITT population, based on physician-prescribed data, was -2.57 (±3.56) l/week, correlating to a -39.11% (±40.79) mean decrease, compared to 0.43 (±0.75) l/week, correlating to a 7.38% (±12.76) increase in the standard of care cohort.
Maltese: Il-bidla medja fil-volum tan-nutrizzjoni parenterali mil-linja bażi f'Ġimgħa 12, fil-popolazzjoni ITT, ibbażata fuq dejta minn kura mogħtija b'riċetta mit-tabib, kienet ta' -2.57 (±3.56) l/ġimgħa li tikkorrela ma' tnaqqis medju ta' -39.11% (±40.79), meta mqabbla ma' 0.43 (±0.
English: In total 88 patients participated in this extension study, thereof 39 treated with placebo and 12 enrolled, but not randomised, in the previous study; 65 of 88 patients completed the extension study.
Maltese: B'kollox, 88 pazjent ħadu sehem f'dan l-istudju ta' estensjoni, li minnhom 39 kienu trattati bi plaċebo u 12 ġew irreġistrati, iżda mhux magħżula b'mod każwali, fl-istudju ta' qabel; 65 minn 88 pazjent lestew l-istudju ta' estensjoni.
English: Gastrointestinal neoplasia including hepatobiliary tract In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts.
Maltese: Revestive jintuża bħala trattament ta' tfal u adolexxenti (li jkollhom sena u aktar) għas-Sindrome talMusrana ż-Żgħira.
English: Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies.
Maltese: Każijiet ta' koleċistite, kolangite, u kolelitijasi ġew irrappurtati fi studji kliniċi.
English: After reconstitution, each vial contains 1.25 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Maltese: Wara rrikostituzzjoni, kull kunjett fih 1.25 mg ta' teduglutide f'0.5 ml ta' soluzzjoni li jikkorrispondi għal konċentrazzjoni ta' 2.5 mg/ml.
English: Teduglutide was not associated with effects on reproductive performance, in utero or developmental parameters measured in studies to investigate fertility, embryo-foetal development and pre- and post-natal development.
Maltese: Teduglutide ma kienx assoċjat ma' effetti fuq il-prestazzjoni riproduttiva, in utero jew parametri ta' żvilupp imkejla fi studji biex jistħarrġu l-fertilità, l-iżvilupp embrijofetali u l-iżvilupp ta' qabel u wara t-twelid.
English: - Read the Package Leaflet before using Revestive.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Reconstituted product Chemical and physical in-use stablility has been demonstrated for 24 hours up to 25°C.
Maltese: Madankollu, stabbilità kimika u fiżika ntweriet għal 24 siegħa f'temperatura ta' 25°C.
English: - Revestive is for injection under the skin (subcutaneous injection).
Maltese: - Reazzjoni allerġika (sensittività eċċessiva)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Dan il-prodott mediċinali fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: 1.25 mg strength Volume to be injected
Maltese: Qawwa ta' 1.25 mg Volum li jrid jiġi injettat
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi ta' MedDRA u l-frekwenza.
English: Of responders in the pivotal study who completed the extension study, 21 out of 22 (96%) sustained their response to teduglutide after an additional 2 years of continuous treatment.
Maltese: estensjoni, 21 minn 22 (96%), sostnew ir-rispons tagħhom għal teduglutide wara trattament kontinwu ta' sentejn addizzjonali.
English: Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Maltese: Pazjenti bi storja ta' tumuri malinni fil-passaġġ gastrointestinali, li jinkludu s-sistema epatobiljari u l-frixa fl-aħħar ħames snin.
English: These 10 subjects had required parenteral nutrition support for 1.2 to 15.5 years, and prior to treatment with teduglutide had required between 3.5 l/week and 13.4 l/week of parenteral nutrition support.
Maltese: Dawn l-10 individwi kienu jeħtieġu appoġġ nutrizzjonali parenterali għal 1.2 sa 15.5 snin, u qabel it-trattament b'teduglutide kienu jeħtieġu bejn 3.5 l/ġimgħa u 13.4 l/ġimgħa ta' appoġġ nutrizzjonali parenterali.
English: VIAL LABEL
Maltese: Ħoll it-trab