FrancophonIA/ELRC3.0 huggingface dataset:
English: Jytte Lyngvig, the chair of the group, informed the Board that the work takes place in the areas of negotiated procedures, centralised oversight of tendering and use of exceptions.
Maltese: Jytte Lyngvig, il-president tal-grupp, infurmat lill-Bord li x-xogħol qiegħed jitwettaa fl-oqsma tal-proċeduri negozjati, is-sorveljanza ċċentralizzata u l-użu ta' eċċezzjonijiet.
English: [EMA/MB/653974/2011] The Management Board noted the mid-year report 2011.
Maltese: [EMA/MB/653974/2011] Il-Bord ta' Tmexxija nnota r-rapport ta' nofs is-sena għall-2011.
English: • Establishment and functioning of health technology assessment bodies and arrangements to grant financial support to HTA activities.
Maltese: • It-twaqqif u l-funzjonament ta' korpi ta' valutazzjoni tat-teknoloġija tas-saħħa u ta' arranġamenti biex jingħata appoġġ finanzjarju lill-attivitajiet tal-HTA.
English: It was also discussed that coordination with the DISCONTOOLS project (a joint initiative with industry and other stakeholders conducted under the European Technology Platform for Global Animal Health) could be explored, e.g. by including diseases identified in the DISCONTOOLS project within the policy.
Maltese: Ġie diskuss ukoll li l-koordinazzjoni mal-proġett DISCONTOOLS (inizjattiva konġunta malindustrija u partijiet interessati oħra mwettqa taħt il-Pjattaforma Ewropea tat-Teknoloġija għas-Saħħa Globali tal-Annimali) tista' tiġi esplorata, eż. billi jiġi inkluż mard identifikat fil-proġett DISCONTOOLS fi ħdan il-politika.
English: • [EMA/MB/714970/2011] Outcome of written procedures during the period from 17 May 2011 to 14
Maltese: • [EMA/MB/714970/2011] Eżitu tal-proċeduri bil-miktub matul il-perjodu mis-17 ta' Mejju 2011 sal14 ta' Settembru 2011.
English: EMA mid-year report 2011 from the Acting Executive Director (January - June 2011)
Maltese: Rapport ta' nofs is-sena tal-EMA għall-2011 mill-Aġent Direttur Eżekuttiv (Jannar - Lulju 2011)
English: Management Board meeting,
Maltese: Kap tat-Taqsima Amministrattiva.
English: Implementation of the EMA road map to 2015
Maltese: Implimentazzjoni tal-pjan direzzjonali tal-EMA għall-2015
English: [EMA/MB/793453/2011] The Management Board noted the report on the implementation of telematics projects.
Maltese: [EMA/MB/653974/2011] Il-Bord ta' Tmexxija nnota r-rapport dwar l-implimentazzjoni tal-proġetti telematiċi.
English: • European networks of reference for rare diseases (setting the criteria to identify networks, their financing, functioning).
Maltese: • Netwerk Ewropew ta' referenza għal mard rari (stabbilment ta' kriterji biex jiġu identifikati nnetwerks, l-finanzjament u l-funzjonalità tagħhom).
English: It was agreed that the website information on this topic would be made more specific to explicitly confirm that any experts who have not submitted a valid, signed declaration will not be involved in any EMA activities.
Maltese: Għandu jiġi nnutat li l-maġġoranza tal-esperti li ma rċevewx id-dikjarazzjoni ta' interessi tagħhom, mhumiex involuti fl-attivitajiet tal-EMA.
English: The policy was seen as another good example of how joint activities between the national agencies and the EMA contribute to bringing to the market products whose development could otherwise be discontinued.
Maltese: Il-politika kienet meqjusa bħala eżempju tajjeb ieħor ta' kif lattivitajiet konġunti bejn l-aġenziji nazzjonali u l-EMA jikkontribwixxu sabiex iġibu fis-suq, prodotti li liżvilupp tagħhom jista' altrimenti jitwaqqaf.
English: • Amendments of the fee regulation to include fees foreseen in the pharmacovigilance legislation (a European Commission proposal is expected later in 2012.
Maltese: • Emendi tar-regolament dwar id-drittijiet sabiex jinkludi d-drittijiet previsti fil-leġiżlazzjoni dwar ilfarmakoviġilanza (iktar tard fl-2012 hija mistennija proposta tal-Kummissjoni Ewropea.
English: Minutes of the 73rd meeting of the Management Board
Maltese: Minuti tat-73 laqgħa tal-Bord ta' Tmexxija
English: • A call for expressions of interest for membership of some EMA committees and of its Management Board (published on 30 September 2011; the call is open till the beginning of December 2011).
Maltese: • Sejħa għal Espressjoni ta' Interess għall-isħubija ta' ċerti kumitati tal-EMA u tal-Bord ta' Tmexxija tagħhom (ippubblikata fit-30 ta' Settembru 2011; is-sejħa hija miftuħa salbidu ta' Diċembru 2011).
English: Launch of a new human resources management system
Maltese: Tnedija ta' sistema ġdida ta' ġestjoni tar-riżorsi umani
English: Members discussed that for the majority of experts who had direct interests, it was not an issue to discontinue those interests.
Maltese: Il-membri ddiskutew li għall-maġġoranza tal-esperti li kellhom interessi diretti, it-twaqqif ta' dawk l-interessi ma kinitx problema.
English: With regard to initiatives in the field of transparency, it was reiterated that the Agency will aim to implement a policy for proactive release of milestone documents emanating from the opinion-making process.
Maltese: Fir-rigward tal-inizjattivi fil-qasam tat-trasparenza, kien imtenni li l-Aġenzija sejra jkollha l-għan li timplimenta politika għar-rilaxx proattiv ta' dokumenti ewlenin li joriġinaw mill-proċess ta' teħid ta' opinjoni.
English: As a consequence, the implementation has been reprioritised in the following way: activities contributing to public health were given the highest priority, followed by activities increasing transparency and improving communication, followed by simplification measures.
Maltese: Bħala konsegwenza, l-implimentazzjoni ġiet riprijoritizzata kif ġej: l-attivitajiet li jikkontribwixxu għas-saħħa pubblika ngħataw l-ogħla prijorità, segwiti minn attivitajiet li jżiedu t-trasparenza u li jtejbu lkomunikazzjoni, segwiti minn miżuri ta' simplifikazzjoni.
English: • HMA work in the area of support to innovation (health technology assessment, discussions on medical devices and the impact of the recast of the related legislation).
Maltese: • Ħidma HMA fil-qasam tal-appoġġ għall-innovazzjoni (valutazzjoni tat-teknoloġija tas-saħħa, diskussjoni dwar l-apparat mediku u l-impatt tar-riformulazzjoni tal-leġiżlazzjoni relatata).
English: Historically, a complex governance structure, loss of knowledge during the implementation phase, loss of continuity between projects and inadequate representation of business users were among the negative factors that partly affected delivery of projects.
Maltese: Storikament, struttura ta' tmexxija kumplessa, telf ta' għarfien matul il-fażi ta' implimentazzjoni, telf ta' kontinwità bejn il-proġetti u rappreżentanza inadegwata ta' utenti kummerċjali kienu fost il-fatturi negattivi li parzjalment affettwaw it-twettiq tal-proġetti.
English: A parallel project is ongoing to organise the work of staff.
Maltese: Rappreżentanti ta' organizzazzjonijiet talpazjenti
English: European Anti-Fraud Office (OLAF) investigation
Maltese: Investigazzjoni tal-Uffiċċju Ewropew Kontra l-Frodi (OLAF)
English: • Ketoconazole.
Maltese: • Ketokonazole.
English: • Rifampicin.
Maltese: • Rifampċin.
English: System organ class
Maltese: Is-sistema ta' klassifika talorgani
English: Dipeptidyl peptidase 4 (DPP4) inhibitors, ATC code: A10BH03
Maltese: Inibitur ta' Dipeptidyl peptidase-4 (DPP4), Kodiċi ATC: A10BH03
English: Additional analysis did not indicate a differential effect among NYHA classes.
Maltese: Analiżi addizzjonali ma tindikax effett differenzjali fost klassijiet ta' NYHCA.
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml, respectively.
Maltese: Il-valuri korrispondenti tas-Cmax kienu 24 ng/mL u 47 ng/mL, rispettivament.
English: Each tablet contains 99 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 99 mg lactose (bħala monohydrate).
English: Dermatitis†
Maltese: Dermatite†
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurta
English: • Uncommon: tiredness, abnormal lipid (fatty acids) levels (dyslipidaemia, hypertriglyceridaemia).
Maltese: • Mhux komuni: għeja, livelli abnormali tal-lipidi (fatty acids) (dislipidemija, ipertrigliċeridemija).
English: • Printing ink: shellac; indigo carmine aluminium lake (E132).
Maltese: • Linka għal istampar: shellac; indigo carmine aluminium lake (E132).
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
Maltese: Fi studji in vitro, saxagliptin u l-metabolu ewlieni la inibixxa CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A4, u l-anqas induċa CYP1A2, 2B6, 2C9, jew 3A4.
English: n=Randomised patients (primary efficacy-intention-to-treat analysis) with data available.
Maltese: n=Pazjenti randomizzati (analiżi primarja effikaċja- intenzjoni li tikkura) bid-dejta disponibbli.
English: Date of first authorisation: 01 October 2009 Date of latest renewal: 18 July 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 01 t'Ottubru 2009 Data tal-aħħar tiġdid: 18 ta' Lulju 2014
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje L-Isvezja
English: • Dexamethasone - a steroid medicine.
Maltese: • Dexamethasone- mediċina ta' sterojd.
English: Saxagliptin with a sulphonylurea (glibenclamide)
Maltese: Saxagliptin ma' sulphonylurea (glibenclamide)
English: p=0.0157 compared to placebo.
Maltese: p=0.0157 mqabbel mal- plaċebo.
English: EU/1/09/545/011 EU/1/09/545/012 EU/1/09/545/013 EU/1/09/545/014 EU/1/09/545/015
Maltese: EU/1/09/545/011 EU/1/09/545/012 EU/1/09/545/013 EU/1/09/545/014
English: • Study CV181168: sequential add-on to dapagliflozin + metformin (n=315)
Maltese: • Studju CV181168: żieda sekwenzjali ma' dapagliflozin + metformin (n=315)
English: Difference from saxagliptin + metformin (adjusted mean (95% CI)
Maltese: Differenza minn saxagliptin + metformin (medja aġġustata (95 % CI)
English: Elderly (≥ 65 years)
Maltese: Anzjani (>65 sena)
English: The tablets contain lactose monohydrate.
Maltese: Il-pilloli fihom lactose monohydrate.
English: -0.6 (evening)
Maltese: -0.6 (filgħaxija)
English: Onglyza 2.5 mg film-coated tablets EU/1/09/545/011-015
Maltese: Onglyza 2.5 mg pilloli miksija b'rita EU/1/09/545/011-015
English: No data are available.
Maltese: Ma hemmx dejta disponibbli.
English: Mean baseline HbA1c
Maltese: Linja bażi medja HbA1c tibdil
English: Acute Pancreatitis
Maltese: Pankrejatite akuta
English: Pancreatitis†
Maltese: Pankreatite†
English: Onglyza 5 mg film-coated tablets EU/1/09/545/001-010
Maltese: Onglyza 5 mg pilloli miksija b'rita EU/1/09/545/001-010
English: The adverse reactions are listed by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skond is-sistema ta' klassifika tal-organi u l-frekwenza assoluta.
English: • Study CV181057: add-on to insulin (+/-metformin) Overall population (n=300)
Maltese: • Studju CV181057: miżjud mal-insulina (+/metformin) Popolazzjoni globali (n=300)
English: Urticaria†
Maltese: Urtikarja†
English: • Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide red (E172).
Maltese: (polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc(E553b) u iron oxide red (E172).
English: Musculoskeletal and connective tissue disorders Arthralgia
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi Artralġija
English: • Study D1680L00006: add-on to metformin plus SU (n=257)
Maltese: • Studju D1680L00006: miżjud ma metformin flimkien ma' SU (n=257)
English: • Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide yellow (E172).
Maltese: (polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc(E553b) u iron oxide yellow (E172).
English: Alu/Alu blister.
Maltese: Folja Alu/Alu.
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Maltese: Metformin kien miżjud bil-mod minn 500 għal 2000 mg kuljum skond kif tollerat.
English: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Maltese: Il-metaboliżmu ta' saxagliptin huwa medjat l-aktar permezz ta' cytochrome P450 3A4/5 (CYP3A4/5).
English: • Tablet core: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate.
Maltese: • Qalba tal-pillola: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate,
English: EU/1/09/545/001 EU/1/09/545/002 EU/1/09/545/003 EU/1/09/545/004 EU/1/09/545/005 EU/1/09/545/006 EU/1/09/545/007 EU/1/09/545/008 EU/1/09/545/009 EU/1/09/545/010
Maltese: EU/1/09/545/007 EU/1/09/545/008 EU/1/09/545/009 EU/1/09/545/010
English: The SAVOR trial included 8240 patients treated with Onglyza 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Maltese: Il-prova SAVOR inkludiet 8240 pazjent ikkurati b'Onglyza 5 mg jew 2.5 mg darba kuljum u 8173 pazjent fuq plaċebo.
English: Metabolism and nutrition disorders Hypoglycaemia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni Ipogliċemija
English: Infections and infestations Upper respiratory infection
Maltese: Infezzjonijiet u Infestazzjonijiet Infezzjoni fit-tratt respiratorju ta' fuq
English: In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Maltese: Minbarra hekk, saxagliptin ma bidilx b'mod sinifikanti ilfarmakokinetika ta' metformin, glibenclamide, pioglitazone, digoxin, simvastatin, il-komponenti attivi tal-kontraċettiv orali kkombinat (ethinyl estradiol u norgestimate), diltiazem jew ketoconazole.
English: The overall incidence of adverse events in patients treated with Onglyza in this trial was similar to placebo (72.5% versus 72.2%, respectively).
Maltese: L-inċidenza ġenerali tal-episodji avversi fil-pazjenti kkurati b'Onglyza f'din ilprova kienet simili għall-plaċebo (72.5% kontra 72.2%, rispettivament).
English: • Study CV181014: add-on to metformin (n=186)
Maltese: • Studju CV181014: miżjud ma metformin (n=186)
English: There was a numerical imbalance in non-CV death, with more events on saxagliptin (1.8%) than placebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
Maltese: Kien hemm żbilanċ numeriku f'mewt mhux CV, b'aktar avvenimenti f'saxagliptin (1.8%) milli fil-plaċebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
English: Table 4 Primary and Secondary Clinical Endpoints by Treatment Group in the SAVOR Study*
Maltese: Tabella 4: Punti ta' tmiem Kliniċi Primarji u Sekondarji skont il-Grupp ta' Kura fl-Istudju SAVOR*
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP4) inhibitor (see sections 4.4 and 4.8).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jekk fil-passat kien hemm reazzjoni ta' sensittività eċċessiva serja, inkluża reazzjoni anafilattika, xokk anafilattiku u anġjoedema, għal kwalunkwe inibitur ta' dipeptidyl peptidase-4 (DPP4) (ara sezzjonijiet 4.4 u 4.8).
English: Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza.
Maltese: Raxx intwera b'Onglyza (ara sezzjoni 4) u b'ċerti mediċini kontra d-dijabete ta' l-istess klassi ta' Onglyza.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Maltese: Saxagliptin ma kienx ġenotossiku f'serje konvenzjonali ta' studji ġenotossiċi in vitro u in vivo.
English: Table 1 Frequency of adverse reactions by system organ class from clinical trials and postmarketing experience
Maltese: Tabella 1 Frekwenza ta' reazzjonijiet avversi skont is-sistema ta' klassifika tal-organi minn provi kliniċi u l-esperjenza ta' wara t-tqegħid fis-suq
English: Onglyza 5 mg film-coated tablets Polyvinyl alcohol Macrogol 3350
Maltese: Onglyza 5 mg pilloli miksija b'rita Polyvinyl alcohol Macrogol 3350
English: Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Daqsijiet ta' pakketti 30x1 u 90x1 pilloli miksija b'rita ġo folji mtaqqbin madwar kull doża.
English: The study population included those ≥65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Maltese: Ilpopolazzjoni tal-istudju inkludiet dawk ≥65 sena (n=8561) u ≥ 75 sena (n=2330), b'indeboliment renali normali jew ħafif (n=13,916) kif ukoll indeboliment renali moderat (n=2240) jew sever (n=336).
English: The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Maltese: L-esponiment tal-metabolu attiv u lattività ta' inibizzjoni ta' DPP4 fil-plasma wara intervall ta' doża, ma ġewx influwenzati b'rifampicin (ara sezzjoni 4.4).
English: Individuals treated with saxagliptin added to dapagliflozin and metformin (n=153) achieved statistically significantly (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo added to dapagliflozin plus metformin (n=162) at 24 weeks (see Table 2).
Maltese: L-individwi kkurati b'saxagliptin miżjud ma' dapagliflozinu metformin (n=153) kisbu tnaqqis statistikament ferm akbar (valur-p < 0.0001) f'HbA1c kontra l-grupp bi plaċebo miżjud ma' dapagliflozin u metformin (n=162) f'24 ġimgħa (ara Tabella 2).
English: In subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Maltese: F'individwi b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A), moderat (Child-Pugh Klassi B), jew qawwi (Child-Pugh Klassi C) l-esponimenti għall- saxagliptin kienu 1.1-, 1.4- u 1.8-il darba aktar għolja, rispettivament, u l-esponimenti għall-BMS-510849 kienu 22%, 7% u 33% aktar baxxi, rispettivament, minn dawk osservati f'individwi b'saħħithom.
English: During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Maltese: Waqt esperjenza ta' wara t-tqegħid fis-suq, inklużi rapporti spontanji u provi kliniċi, ir-reazzjonijiet avversi li ġejjin kienu rrappurtati bl-użu ta' saxagliptin: reazzjonijiet ta' sensittività eċċessiva serja inkluża reazzjoni anafilattika, xokk anafilattiku, u anġjoedema.
English: What Onglyza contains - The active substance is saxagliptin.
Maltese: • Is-sustanza attiva hi saxagliptin.
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), or not known (cannot be estimated from the available data).
Maltese: (1/1000 sa <1/100), rari (1/10,000 sa <1/1000), jew rari ħafna (<1/10,000), jew mhux magħruf (ma jistax jiġi stmat minn dejta disponnibli).
English: Joint pain, which may be severe, has been reported in postmarketing reports for DPP4 inhibitors (see section 4.8).
Maltese: Uġigħ fil-ġoġi, li jista' jkun sever, ġie rrapportat f'rapporti ta' wara t-tqegħid fis-suq għall-inibituri DPP4 (ara sezzjoni 4.8).
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Onglyza clinical program.
Maltese: Pazjenti b'immunita kompromessa, bħal pazjenti li kellhom trapjant ta' organu jew pazjenti bi dijanjosi ta' sindrome ta' nuqqas immuni uman, ma ġewx studjati fil-program kliniku ta' Onglyza.
English: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes MellitusThrombolysis in Myocardial Infarction (SAVOR) Study SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and <12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Maltese: Rreġistrati f'Pazjenti b'Dijabete MellitusTromboliżi fi Studju ta' Infart Mijokardijaku (SAVOR) SAVOR kienet prova ta' riżultat CV f'16,492 pazjent b'HbA1c ≥6.5% u <12% (12959 b'marda CV stabbilita; 3533 b'fatturi ta' riskju multipli biss) li ġew randomizzati għal saxagliptin (n=8280) jew plaċebo (n=8212) miżjud ma' standards reġjonali ta' kura għal HbA1c u fatturi ta' riskju ta' CV.
English: GENERATION was a 52-week glycaemic control study in 720 elderly patients, the mean age was 72.6 years; 433 subjects (60.1%) were < 75 years of age, and 287 subjects (39.9%) were ≥ 75 years of age.
Maltese: GENERATION kien studju ta' kontroll gliċemiku ta' 52 ġimgħa fuq 720 pazjent anzjan, bl-età medja kienet 72.6 sena; 433 individwu (60.1%) kellhom <75 sena, u 287 individwu (39.9%) kellhom ≥75 sena.
English: In the saxagliptin and dapagliflozin combination group, 41.4% (95% CI [34.5, 48.2]) of patients achieved HbA1c levels of less than 7% compared to 18.3% (95% CI [13.0, 23.5]) of patients in the saxagliptin group and 22.2% (95% CI [16.1, 28.3]) of patients in the dapagliflozin group.
Maltese: Fil-grupp ta' kombinazzjoni ta' saxagliptin u dapagliflozin, 41.4 % (95 % CI [34.5, 48.2]) tal-pazjenti kisbu livelli ta' HbA1c ta' inqas minn 7 % meta mqabbel ma' 18.3 % (95 % CI [13.0, 23.5]) talpazjenti fil-grupp ta' saxagliptin u 22.2 % (95 % CI [16.1, 28.3]) tal-pazjenti fil-grupp ta' dapagliflozin.
English: • 5 mg tablets are available in pack sizes of 14, 28, 56, or 98 film-coated tablets in non-perforated blisters, 14, 28, 56, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: • Il-pilloli ta' 5 mg jiġu f' daqsijiet tal-pakkett ta'14, 28, 56, jew 98-il pillola miksija b'rita ġo folji mhux imtaqqbin, 14, 28, 56 jew 98-il pillola miksija b'rita ġo folji bil-kalendarju mhux imtaqqbin u 30x1 jew 90x1 pillola miksija b'rita ġo folji mtaqqbin madwar kull doża
English: Saxagliptin as add-on to metformin plus a sulphonylurea
Maltese: Saxagliptin bħala suppliment għal metformin flimkien ma' sulphonylurea
English: • Study CV181038 (n=69)
Maltese: • Stuju CV181011 (n=103) • Stuju CV181038 (n=69)
English: The proportion of patients achieving HbA1c < 7% at Week 24 was higher in the saxagliptin 5 mg plus dapagliflozin plus metformin group 35.3% (95% CI [28.2, 42.4]) compared to the placebo plus dapagliflozin plus metformin group 23.1% (95% CI [16.9, 29.3]).
Maltese: Il-proporzjon ta' pazjenti li kisbu HbA1c < 7% f'Ġimgħa 24 kien ogħla fil-grupp ta' saxagliptin 5 mg flimkien ma' dapagliflozin flimkien ma' metformin 35.3 % (95 % CI [28.2, 42.4]) meta mqabbel malgrupp tal-plaċebo flimkien ma' dapagliflozin flimkien ma' metformin 23.1 % (95 % CI [16.9, 29.3]).
English: • Study CV181013: add-on to TZD (n=183)
Maltese: • Studju CV181013: miżjud ma TZD (n=183)
English: Saxagliptin add-on to glibenclamide therapy
Maltese: Saxagliptin miżjud ma' terapija ta' glibenclamide
English: Saxagliptin (n=183) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=180).
Maltese: Saxagliptin (n=183) ġab titjib sinifikanti fl-HbA1c, FPG, u PPG mqabbel mal-plaċebo (n=180).
English: Other medicines and Onglyza
Maltese: Mediċini oħra u Onglyza
English: The most commonly reported adverse reactions in placebo-controlled trials reported in ≥5% of patients treated with Onglyza 5 mg and more commonly than in patients treated with placebo are upper respiratory tract infection (7.7%), urinary tract infection (6.8%) and headache (6.5%).
Maltese: L-iktar reazzjonijiet avversi rrapportati b'mod komuni fi provi kliniċi kkontrollati bil-plaċebo rrapportati f'>5% tal-pazjenti kkurati b'Onglyza 5 mg u b'mod iktar komuni milli f'pazjenti kkurati bil-plaċebo huma infezzjoni fil-parti ta' fuq tal-apparat respiratorju (7.7%), infezzjoni tal-apparat talawrina (6.8%) u uġigħ ta' ras (6.5%).