FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/456/001 14 film-coated tablets EU/1/08/456/002 28 film-coated tablets EU/1/08/456/003 56 film-coated tablets EU/1/08/456/019 60 film-coated tablets EU/1/08/456/004 112 film-coated tablets EU/1/08/456/005 168 film-coated tablets EU/1/08/456/020 180 film-coated tablets EU/1/08/456/006 196 film-coated tablets EU/1/08/456/007 50 x 1 film-coated tablets EU/1/08/456/015 196 (2 x 98) film-coated tablets EU/1/08/456/017 168 (2 x 84) film-coated tablets
Maltese: EU/1/08/456/019 60 pillola miksija b'rita EU/1/08/456/004 112-il pillola miksija b'rita EU/1/08/456/005 168 pillola miksija b'rita EU/1/08/456/020 180 pillola miksija b'rita EU/1/08/456/006 196 pillola miksija b'rita EU/1/08/456/007 50 x 1 pillola miksija b'rita EU/1/08/456/015 196 (2 pakketti ta' 98) pillola miksija b'rita EU/1/08/456/017 168 (2 pakketti ta' 84) pillola miksija b'rita
English: Velmetia contains two different medicines called sitagliptin and metformin.
Maltese: Velmetia fih żewġ mediċini differenti msejħin sitagliptin u metformin.
English: EU/1/08/456/008 14 film-coated tablets EU/1/08/456/009 28 film-coated tablets EU/1/08/456/010 56 film-coated tablets EU/1/08/456/021 60 film-coated tablets EU/1/08/456/011 112 film-coated tablets EU/1/08/456/012 168 film-coated tablets EU/1/08/456/022 180 film-coated tablets EU/1/08/456/013 196 film-coated tablets EU/1/08/456/014 50 x 1 film-coated tablets EU/1/08/456/016 196 (2 x 98) film-coated tablets EU/1/08/456/018 168 (2 x 84) film-coated tablets
Maltese: EU/1/08/456/008 14-il pillola miksija b'rita EU/1/08/456/009 28 pillola miksija b'rita EU/1/08/456/010 56 pillola miksija b'rita EU/1/08/456/021 60 pillola miksija b'rita EU/1/08/456/011 112-il pillola miksija b'rita EU/1/08/456/012 168 pillola miksija b'rita EU/1/08/456/022 180 pillola miksija b'rita
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isoenzymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Maltese: Tagħrif in vitro wera li sitagliptin mhuwiex impeditur ta' iżoenzimi CYP CYP3A4, 2C8, 2C9, 2D6,
English: Velmetia is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Maltese: Velmetia huwa indikat f'kumbinazzjoni ma' sulphonylurea (jiġifieri, terapija ta' kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Maltese: metformin, konċentrazzjonijiet ta' stat fiss fil-plażma jintlaħqu fi żmien 24-48 siegħa u huma ġeneralment inqas minn1 µg/mL.
English: The dose of antihyperglycaemic therapy with Velmetia should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Maltese: Id-doża ta' terapija kontra l-ipergliċemija b'Velmetia għandha tkun individwalizzata fuq il-bażi talkors kurrenti, l-effettività, u t-tolerabbilità tal-pazjent waqt li ma tinqabiżx id-doża massima ta' kuljum irrakkomandata ta' 100 mg sitagliptin.
English: Hepatic impairment Velmetia must not be used in patients with hepatic impairment (see section 5.2).
Maltese: Velmetia ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: For the different doses on metformin, Velmetia is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Maltese: Għal dożi differenti ta' metformin, Velmetia jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1,000 mg metformin hydrochloride.
English: Velmetia is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Maltese: Velmetia huwa indikat bħala terapija tripla kombinata ma' agonist ta' peroxisome proliferator-activated receptor gamma (PPARγ) (jiġifieri, thiazolidinedione) bħala żieda mad-dieta u l eżerċizzju f'pazjenti mhux ikkontrollati adegwatament b'metformin u agonist ta' PPARγ bid-doża massima ttollerata tagħhom.
English: EU/1/08/456/010 EU/1/08/456/011 EU/1/08/456/012 EU/1/08/456/013 EU/1/08/456/014 EU/1/08/456/016 EU/1/08/456/018 EU/1/08/456/021 EU/1/08/456/022
Maltese: EU/1/08/456/016 EU/1/08/456/018 EU/1/08/456/021 EU/1/08/456/022
English: Velmetia 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Velmetia 50 mg/1,000 mg sitagliptin/metformin hydrochloride
English: EU/1/08/456/008 EU/1/08/456/009
Maltese: EU/1/08/456/008 EU/1/08/456/009 EU/1/08/456/010
English: A bioequivalence study in healthy subjects demonstrated that the Velmetia (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Maltese: Studju ta' bijoekwivalenza f'suġġetti b'saħħithom wera li pilloli ta' kumbinazzjoni Velmetia (sitagliptin/metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta' sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
English: Velmetia is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Maltese: Velmetia huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament fil preżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: Velmetia 50 mg/850 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Velmetia 50 mg/850 mg sitagliptin/metformin hydrochloride
English: Velmetia 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Velmetia 50 mg/850 mg pillola miksija b'rita sitagliptin/metformin hydrochloride
English: Velmetia must therefore not be used in women who are breast-feeding (see section 4.3).
Maltese: Velmetia (ara sezzjoni 4).
English: Frequency of adverse reaction upper abdominal pain
Maltese: Skop Finali Kompost Primarju
English: When Velmetia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: sulphonylurea, tista' tkun meħtieġa doża aktar baxxa ta' sulphonylurea biex tnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: Velmetia may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: Velmetia jista' jikkawża effett sekondarju rari ħafna, (jista' jaffettwa sa persuna 1 minn kull 10,000 li qed jużawh), iżda serju ħafna li jissejjaħ aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Neopharmed Gentili S.p.A. Tel: +39 02891321 regulatory@neogen.it
Maltese: Tel: +39 02891321
English: Velmetia 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Velmetia 50 mg/1,000 mg pilloli miksijin b'rita sitagliptin/metformin hydrochloride
English: Velmetia 50 mg/850 mg film-coated tablets
Maltese: Velmetia 50 mg/850 mg pilloli miksijin b'rita
English: In addition, osteoarthritis and pain in extremity were reported with frequency uncommon (> 0.5 % higher among sitagliptin users than that in the control group).
Maltese: Barra dan, osteoartrite u uġigħ fl-idejn u fis-saqajn kienu rrappurtatibi frekwenza mhix komuni (> 0.5 % ogħla fost dawk li jużaw sitagliptin minn dawk fil-grupp ta' kontroll).
English: Velmetia is contraindicated in patients with:
Maltese: Velmetia huwa kontraindikat f'pazjenti b':
English: POLPHARMA Biuro Handlowe Sp. z o.o.
Maltese: Ferrer Internacional, S.A.
English: The safety and efficacy of Velmetia in children and adolescents from birth to < 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Velmetia fit-tfal u adoloxxenti mit-twelid sal-età ta' < 18-il sena ma ġewx determinati s'issa.
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunwke aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Uncommon angioedema
Maltese: angiotensin II)
English: There have been no therapeutic clinical trials conducted with Velmetia tablets however bioequivalence of Velmetia with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Ma saru l-ebda provi terapewtiċi kliniċi b'pilloli Velmetia, madankollu ntweriet il-bijoekwivalenza ta' Velmetia ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: Velmetia must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Maltese: Aċidożi lattika hija emerġenza medika u għandha tiġi ttrattata fi sptar.
English: Further information on Ondexxya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ondexxya.
Maltese: ema.europa.eu/medicines/human/EPAR/ondexxya.
English: Ondexxya (andexanet alfa)
Maltese: Ondexxya (andeksanet alfa)
English: Other information about Ondexxya
Maltese: Informazzjoni oħra dwar Ondexxya
English: Ondexxya contains the active substance andexanet alfa.
Maltese: Ondexxya fih is-sustanza attiva andeksanet alfa.
English: After treatment with Ondexxya, antifactor Xa activity was reduced on average by 90% in 83 patients taking apixaban and by 78% in 70 patients taking rivaroxaban.
Maltese: Wara l-kura b'Ondexxya, l-attività tal-antifattur Xa tnaqqset b'medja ta' 90 % fi 83 pazjent li kienu qed jieħdu apixaban u bi 78 % f'70 pazjent li kienu qed jieħdu rivaroxaban.
English: In the first study, involving people who had taken apixaban, the full dose of Ondexxya reduced antifactor Xa activity by 92% on average in 23 people compared with 33% in 8 people receiving placebo (a dummy treatment).
Maltese: Fl-ewwel studju, li jinvolvi persuni li kienu ħadu apixaban, iddoża sħiħa ta' Ondexxya naqqset l-attività tal-antifattur Xa bi 92 % bħala medja fi 23 persuna meta mqabbla ma' 33 % fi 8 persuni li rċevew plaċebo (kura finta).
English: involving people who had taken rivaroxaban, the full dose of Ondexxya reduced antifactor Xa activity by 97% on average in 26 people, compared with 45% in 13 people receiving placebo.
Maltese: Fit-tieni studju, li jinvolvi persuni li kienu ħadu rivaroxaban, id-doża sħiħa ta' Ondexxya naqqset l-attività tal-antifattur Xa b'97 % bħala medja f'26 persuna, meta mqabbla ma'45 % fi 13-il persuna li rċevew plaċebo.
English: Furthermore, the data provided, including some data on reduced bleeding, were considered promising.
Maltese: Barra minn hekk, iddata pprovduta, inkluża xi data dwar tnixxija mnaqqsa ta' demm, tqieset bħala promettenti.
English: What information is still awaited for Ondexxya?
Maltese: Liema informazzjoni għadha mistennija għal Ondexxya?
English: Andexanet alfa, the active substance in Ondexxya, acts as a decoy target for anticoagulants called factor Xa inhibitors such as apixaban and rivaroxaban.
Maltese: L-andeksanet alfa, is-sustanza attiva f'Ondexxya, taġixxi bħala mira tan-nasba għal antikoagulanti msejħa inibituri tal-fattur Xa bħal apixaban u rivaroxaban.
English: What are the risks associated with Ondexxya?
Maltese: X'inhuma r-riskji assoċjati ma' Ondexxya?
English: How is Ondexxya used?
Maltese: Ondexxya?
English: As for all medicines, data on the use of Ondexxya are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ondexxya hija ssorveljata kontinwament.
English: Based on studies in healthy volunteers, the most common side effects with Ondexxya (which may affect more than 1 in 10 people) are flushing, feeling hot, both of which are related to infusing the medicine, and a short-lived increase in levels of certain proteins indicating blood clotting.
Maltese: Abbażi ta' studji f'voluntiera b'saħħithom, l-effetti sekondarji l-aktar komuni b'Ondexxya (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma fwawar, sħanat, it-tnejn li huma relatati malinfużjoni tal-mediċina, u żieda b'ħajja qasira f'livelli ta' ċerti proteini li jindikaw koagulazzjoni taddemm.
English: Patients treated with Ondexxya, especially those aged over 75 years, may be at a higher risk of thromboembolism.
Maltese: Il-pazjenti kkurati b'Ondexxya, speċjalment dawk li għandhom aktar minn 75 sena, jistgħu jkunu f'riskju ogħla ta' tromboemboliżmu.
English: For the full list of side effects and restrictions of Ondexxya, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Ondexxya, ara l-fuljett ta' tagħrif.
English: On the basis of studies in healthy volunteers and preliminary data from studies in patients, Ondexxya was found effective for reducing antifactor Xa activity in those taking anticoagulants that block factor Xa (factor Xa inhibitors).
Maltese: Abbażi ta' studji f'voluntiera b'saħħithom u data preliminari minn studji fil-pazjenti, Ondexxya instab li kien effettiv għat-tnaqqis tal-attività tal-antifattur Xa f'dawk li jieħdu antikoagulanti li jimblukkaw ilfattur Xa (inibituri tal-fattur Xa).
English: These anticoagulants work by blocking factor Xa, a natural protein that helps the blood to clot.
Maltese: Dawn l-antikoagulanti jaħdmu billi jimblukkaw il-fattur Xa, proteina naturali li tgħin id-demm jagħqad.
English: In patients who were bleeding, the most common side effects (affecting around 1 in 10 people) were thromboembolism (problems due to clots in blood vessels such as blocked veins, heart attack and stroke) and fever.
Maltese: F'pazjenti li kien qed ikollhom tnixxija ta' demm, l-effetti sekondarji l-aktar komuni (li jaffettwaw madwar persuna 1 minn kull 10) kienu tromboemboliżmu (problemi minħabba emboli filvażijiet tad-demm bħal vini mblukkati, attakk tal-qalb u puplesija) u deni.
English: The main measure of effectiveness was the reduction in 'antifactor Xa activity' (a measure of how well natural factor Xa is blocked by an anticoagulant).
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis fl-"attività antifattur Xa” (kejl ta' kemm il-fattur naturali
English: Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.
Maltese: Ondexxya huwa mediċina li tintuża biex twaqqaf tnixxija ta' demm ta' periklu għall-ħajja jew mhux ikkontrollata fl-adulti li jieħdu l-mediċini antikoagulanti apixaban jew rivaroxaban.
English: Since Ondexxya has been given conditional authorisation, the company that markets Ondexxya will provide evidence from studies in patients with major bleeding to reliably link antifactor X activity with the ability to stop bleeding and to clarify the risk of thromboembolism.
Maltese: Minħabba li Ondexxya ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tqiegħed Ondexxya fis-suq se tipprovdi evidenza minn studji f'pazjenti bi tnixxija kbira ta' demm biex b'mod affidabbli torbot attività tal-antifattur Xa mal-abbiltà li twaqqaf it-tnixxija ta' demm u biex tiċċara r-riskju ta' tromboemboliżmu.
English: How does Ondexxya work?
Maltese: Kif jintuża Ondexxya?
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu ssodisfati mill-MAH:
English: See also section 5.1.
Maltese: Ara wkoll sezzjoni 5.1.
English: Teduglutide is an analogue of GLP-2.
Maltese: Teduglutide huwa analogu ta' GLP-2.
English: See Table 1 under “Adults” section.
Maltese: Ara Tabella 1 taħt is-sezzjoni “Adulti”.
English: C-reactive protein
Maltese: Proteina reattiva Ċ
English: - Store below 25°C.
Maltese: - Aħżen f'temperatura taħt 25°C.
English: If any powder remains, repeat steps 2.5 and 2.6.
Maltese: Jekk jibqa' xi trab, irrepeti passi 2.5 u 2.6.
English: - The active substance is teduglutide.
Maltese: - Is-sustanza attiva hi teduglutide.
English: Paediatric population (≥1 year)
Maltese: Popolazzjoni pedjatrika (≥1 sena)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX08.
Maltese: Kategorija farmakoterapewtika: prodotti oħrajn għall-passaġġ alimentari u l-metaboliżmu, diversi prodotti għall-passaġġ alimentari u l-metaboliżmu, Kodiċi ATC: A16AX08.
English: Gastric polyp
Maltese: Polipi gastriċi
English: The mean reduction in parenteral nutrition was 3.11 l/week (an additional 28.3% reduction).
Maltese: It-tnaqqis medju finnutrizzjoni parenterali kien ta' 3.11 l/ġimgħa (tnaqqis addizzjonali ta' 28.3%).
English: Colo-rectal polyps/Neoplasia
Maltese: Polipi kolorettali/Neoplażija
English: Cholecystitis Cholecystitis acute
Maltese: Koleċistite Koleċistite akuta
English: Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer-Gasse 5-11
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: *A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology.
Maltese: *Analogu ta' peptide-2 bħal glucagon (GLP-2, glucagon like peptide-2) prodott fiċ-ċelluli ta' Escherichia coli b'teknoloġija rikombinanti tad-DNA.
English: Date of first authorisation: 30 August 2012 Date of latest renewal: 23 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 30 ta' Awwissu 2012 Data tal-aħħar tiġdid: 23 ta' Ġunju 2017
English: Revestive has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Revestive ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.4 u 5.2).
English: The mean reduction in parenteral nutrition (n=30) was 7.55 l/week (a 65.6% reduction from baseline).
Maltese: It-tnaqqis medju fin-nutrizzjoni parenterali (n=30) kien ta' 7.55 l/ġimgħa (tnaqqis ta' 65.6% mil-linja bażi).
English: Complete weaning
Maltese: Ftim komplet
English: Four interim reports will be provided within six months after the data lock points (i.e., Q4 2016, Q4 2018, Q4 2020, and Q4 2022).
Maltese: Erba' rapporti interim għandhom jiġu pprovduti fi żmien sitt xhur wara ddata lock points (i.e., Q4 2016, Q4
English: The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Maltese: Laktar reazzjonijiet avversi komuni li ġew irrappurtati kienu wġigħ u nefħa addominali (45%), infezzjonijiet fl-apparat respiratorju (28%) (li jinkludu nażofarinġite, influwenza, infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju, u infezzjoni fil-parti t'isfel tal-passaġġ respiratorju, dardir (26%), reazzjonijiet fis-sit tal-injezzjoni (26%), uġigħ ta' ras (16%), u rimettar (14%).
English: Three (3) doses of teduglutide, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Maltese: Tliet (3) dożi ta' teduglutide, 0.0125 mg/kg/jum (n=8), 0.025 mg/kg/jum (n=14), u 0.05 mg/kg/jum (n=15), ġew investigati għal 12-il ġimgħa.
English: Intestinal obstruction
Maltese: Ostruzzjoni intestinali
English: The dose will be given in millilitres (ml) of solution.
Maltese: Id-doża ser tingħata f'millilitri (ml) ta' soluzzjoni.
English: Of the 39 placebo subjects, 29 completed 24 months of treatment with teduglutide.
Maltese: Mid-39 individwu fuq plaċebo, 29 lestew 24 xahar ta' trattament b'teduglutide.
English: The single amino acid substitution relative to naturally occurring GLP-2 results in resistance to in vivo degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in an extended half-life.
Maltese: Is-sostituzzjoni unika ta' aċidu amminiku meta mqabbel ma' GLP-2 li sseħħ b'mod naturali tirriżulta f'reżistenza għal degradazzjoni in vivo mill-enzima dipeptidyl peptidase-IV (DPP-IV), li tirriżulta f'half-life estiża.
English: The corresponding change in the standard of care cohort was 4.31% (±5.36).
Maltese: Ilbidla korrispondenti fil-livell tal-koorti ta' standard ta' kura kienet ta' 4.31% (±5.36).
English: Approximately 52% of the patients treated with teduglutide experienced adverse reactions (versus 36% of the patients given placebo).
Maltese: Madwar 52% tal-pazjenti kkurati b'teduglutide esperjenzaw reazzjonijiet avversi (kontra 36% tal-pazjenti li ngħataw plaċebo).
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa <1/10), mhux komuni (≥ 1/1,000 sa <1/100); rari (≥ 1/10,000 sa <1/1,000 ), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The objective was to evaluate safety/tolerability, pharmacokinetics and efficacy of teduglutide.
Maltese: L-għan kien li jiġu evalwati s-sigurtà/tollerabbiltà, il-farmakokinetika u l-effikaċja ta' teduglutide.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (pH adjustment) Hydrochloric acid (pH adjustment)
Maltese: Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (għal aġġustament ta' pH) Hydrochloric acid (għal aġġustament ta' pH)
English: Carcinogenicity / mutagenicity Teduglutide was negative when tested in the standard battery of tests for genotoxicity.
Maltese: Karċinoġeniċità/mutaġeniċità Teduglutide kien negattiv meta ttestjat fis-sensiela ta' testijiet standard għal ġenotossiċità.
English: Three subjects (3/15, 20%) on the recommended teduglutide dose were weaned off parenteral nutrition by Week 12.
Maltese: Tliet individwi (3/15, 20%) fuq id-doża rakkomandata ta' teduglutide infatmu min-nutrizzjoni parenterali sa Ġimgħa 12.
English: Fluid overload
Maltese: Fluwidu eċċessiv
English: Treatment resulted in enhanced gastrointestinal fluid absorption of approximately 750-1000 ml/day with improvements in the absorption of macronutrients and electrolytes, decreased stomal or faecal fluid and macronutrients excretion, and enhanced key structural and functional adaptations in the intestinal mucosa.
Maltese: It-trattament irriżulta f'assorbiment aħjar ta' fluwidi gastrointestinali b'madwar 750-1,000 ml/jum b'titjib fl-assorbiment ta' makronutrijenti u elettroliti, tnaqqis fil-fluwidu stomali jew tal-ippurgar u eliminazzjoni ta' makronutrijenti, u adattamenti funzjonali aħjar fil-mukoża intestinali.
English: Twenty-one (21) patients treated with teduglutide (48.8%) versus 9 on placebo (20.9%) achieved at least a one day reduction in parenteral nutrition administration (p=0.008).
Maltese: Wieħed u għoxrin (21) pazjent ikkurati b'teduglutide (48.8%) kontra 9 fuq il-plaċebo (20.9%) kisbu mill-inqas tnaqqis ta' jum wieħed fl-amministrazzjoni ta' nutrizzjoni parenterali (p=0.008).
English: The change from baseline in the SOC cohort was -0.21 (±0.69) hours/day (-1.75% [±5.89]).
Maltese: 69) sigħat/jum (-1.75% [±5.89]).
English: Solvent for Revestive
Maltese: Tużax Revestive
English: EU/1/12/787/003 28 vials
Maltese: EU/1/12/787/003 28 kunjett
English: The corresponding increase in enteral calories was 58.80% (±64.20), compared to 57.02% (±55.25) in the standard of care cohort.
Maltese: Iż-żieda korrispondenti ta' kaloriji enterali kienet ta' 58.80% (±64.20) meta mqabbla ma' 57.02% (±55.