FrancophonIA/ELRC3.0 huggingface dataset:
English: Day 3
Maltese: ANNESS III
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Maltese: Irreazzjonijiet avversi tal-mediċina jinsabu mniżżla skont is-sistema ta' klassifika tal-organi f'MedDRA.
English: The median duration of exposure to study treatment was 4.6 months (range: 0.1-24.1 months).
Maltese: It-tul medju tal-espożizzjoni għat-trattament waqt l-istudju kien ta' 4.6 xhur (firxa: 0.1-24.1 xhur).
English: Potential contributing factors may include prior history of chemotherapy, stem cell transplant, the nature of the disease and neutropenia or lymphopenia associated with Farydak treatment.
Maltese: Fatturi kontributorji potenzjali jistgħu jinkludu storja eżistenti ta' kemoterapija, trapjant taċ-ċelloli staminali, in-natura tal-marda u n-newtropenija jew il-limfopenija assoċjati mat-trattament b'Farydak.
English: Table 2 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 9-16)
Maltese: Mistrieħ Tabella 2 Skeda tad-doża rrakkomandata ta' panobinostat flimkien ma' bortezomib u dexamethasone (ċikli 9-16)
English: - medicines used to stop seizures or fits (anti-epileptics such as carbamazepine, pherphenazine,
Maltese: Mediċini użati biex jittrattaw it-tuberkolożi, bħal rifabutin jew rifampicin. - mediċini użati biex iwaqqfu aċċessjonijiet (anti-epileptics bħal carbamazepine, pherphenazine,
English: Prior to initiating any cycle of therapy with panobinostat in combination with bortezomib and dexamethasone, platelet count should be at least ≥100 x 109/l (see section 4.4).
Maltese: Qabel ma jinbeda kull ċiklu ta' terapija b'panobinostat flimkien ma' bortezomib u dexamethasone, l-għadd tal-plejtlits għandu jkun mill-inqas ≥100 x 109/l (ara sezzjoni 4.4).
English: There is no relevant use of panobinostat in paediatric patients below the age of 18 years in the indication multiple myeloma (see section 5.2).
Maltese: M'hemm l-ebda użu rilevanti ta' Panobinostat għal pazjenti pedjatriċi li għandhom anqas minn 18il sena fejn tidħol mijeloma multipla (ara sezzjoni 5.2).
English: Due to its cytostatic/cytotoxic mode of action, panobinostat can influence the quality of sperm formed during treatment.
Maltese: Minħabba l-metodu tiegħu ta' azzjoni ċitostatika/ċitotossika, panobinostat jista' jinfluwenza l-kwalità tal-isperma li tifforma tul it-trattament.
English: It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see section 4.8 and section 4.2).
Maltese: Hu rrakkomandat li jkun hemm monitoraġġ aktar ta' spiss tal-pazjenti li għandhom aktar minn 65 sena, b'mod speċjali għal tromboċitopenija u tossiċità gastrointestinali (ara sezzjonijiet 4.4 u 4.8).
English: Table 8 Progression-free survival in patients who received at least two prior regimens including bortezomib and an immunomodulating agent
Maltese: Tabella 8 Sopravivenza ħielsa minn kwalunkwe progressjoni (Progression-free survival) f'pazjenti li ngħataw mill-inqas żewġ reġimi minn qabel li jinkudi bortezomib u aġent immunomodulatorju
English: In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
Maltese: III 162 minn 387 pazjent kellhom 65 sena jew aktar.
English: The primary target organs of toxicity following administration of panobinostat in rats and dogs were identified as the erythropoietic, myelopoietic and lymphatic systems.
Maltese: L-organi primarji milquta mit-tossiċità wara l-għoti ta' panobinostat fil-firien u l-klieb kienu identifikati bħala s-sistemi eritropoietiċi, mijelopoietiċi u limfatiċi.
English: Amongst the patients who died of haemorrhage, one patient had thrombocytopenia grade 4, three patients had thrombocytopenia grade 3 and 1 patient had thrombocytopenia grade 1.
Maltese: Fost il-pazjenti li mietu b'emorraġija, pazjent wieħed kellu tromboċitopenija fil-grad 4, tliet pazjenti kellhom tromboċitopenija fil-grad 3 u pazjent wieħed kellu tromboċitopenija fil-grad 1.
English: - Farydak is taken over 21 days (2 weeks on and 1 week off) - this is called a treatment cycle.
Maltese: • Farydak jittieħed fuq 21 jum (ġimagħtejn iva u ġimgħa le) - dan jissejjaħ ċiklu ta' trattament.
English: Avoid panobinostat use in patients who are taking CYP2D6 substrates with a narrow therapeutic index (including, but not limited to, pimozide).
Maltese: Evita l-użu ta' panobinostat f'pazjenti li qegħdin jieħdu sottostrati ta' CYP2D6 b'indiċi terapewtiku dejjaq (inkluż, iżda mhux limitat għal, pimozide).
English: Patients had to be exposed to an IMiD (lenalidomide or thalidomide).
Maltese: Il-pazjenti kellhom ikunu esposti għal IMiD (lenalidomide jew thalidomide).
English: Panobinostat is administered in combination with bortezomib and dexamethasone, as shown in Tables 1 and 2.
Maltese: Panobinostat jingħata flimkien ma' bortezomib u dexamethasone, kif jidher f'Tabelli 1 u 2.
English: Regardless of events chronology, syncope was reported in 9% of patients with ST-T depression and 7.2% of patients with T wave change and 4.9% of patients with neither of these ECG abnormalities.
Maltese: Irrispettivament mill-kronoloġija tal-avvenimenti, kienet irrapportata sinkope f'9% talpazjenti b'dipressjoni ST-T u f'7.2% tal-pazjenti b'bidliet fil-mewġa T, kif ukoll f'4.9% tal-pazjenti b'ebda waħda minn dawn l-anormalitajiet fl-ECG.
English: Severe nausea, diarrhoea, constipation and vomiting, sometimes requiring the use of anti-emetic and anti-diarrhoeal medicinal products, have been reported in patients treated with Farydak (see section 4.8).
Maltese: Kienu rrappurtati dardir, dijarea, konstipazzjoni u rimettar gravi f'pazjenti ttrattati b'Farydak, li kultant kienu jeħtieġu l-użu ta' prodotti mediċinali antiemetiċi u antidijareali (ara sezzjoni 4.8).
English: How to store Farydak
Maltese: X'inhu Farydak
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Maltese: jew aktar tnaqqis taddoża għal 0.5 mg/m2 fiċ ċikli li jsegwu skont it tollerabbiltà tal-pazjent.
English: Table 7 includes adverse drug reactions that occur due to the addition of panobinostat to the bortezomib and dexamethasone combination.
Maltese: It-Tabella 7 tinkludi reazzjonijiet avversi tal-mediċina li jseħħu minħabba ż-żieda ta' panobinostat mal-kombinazzjoni ta' bortezomib u dexamethasone.
English: G-CSF) according to local guidelines.
Maltese: G-CSF) skont il-linji gwida lokali.
English: Physicians and patients should be aware of the increased risk of infection with panobinostat.
Maltese: It-tobba u l-pazjenti għandhom ikunu konxji taż-żieda fir-riskju ta' infezzjoni b'panobinostat.
English: Prostatic atrophy accompanied by reduced secretory granules, testicular degeneration, oligospermia and increased epididymal debris were observed in dogs at exposures corresponding to 0.41-0.69 of the human clinical AUC and not fully reversible after a 4 week recovery period.
Maltese: Kienu osservati wkoll atrofija prostatika flimkien ma' tnaqqis fil-granuli ta' sekrezzjoni, deġenerazzjoni testikulari, oligospermja u żieda fid-debris epididimali fost il-klieb f'espożizzjonijiet li jikkorrespondu għal 0.
English: The median time to response was 1.4 months and the median duration of response was 6.0 months.
Maltese: Iż-żmien medjan ta' rispons kien ta' 1.4 xhur u d-dewmien medjan ta' rispons kien ta' 6.0 xhur.
English: Chills, malaise
Maltese: Tiħux iddoża
English: Some of these infections (e.g. pneumonia) have been severe (e.g. leading to sepsis, or respiratory or multi-organ failure) and have had fatal outcomes (see section 4.8).
Maltese: Xi wħud minn dawn l-infezzjonijiet (eż. pulmonite) kienu gravi (eż. li wasslu għal sepsis,jew għal insuffiċjenza respiratorja jew ta' bosta organi) u kellhom konsegwenzi fatali (ara sezzjoni 4.8).
English: Platelet transfusions may be required, if clinically indicated (see section 4.4).
Maltese: Jaf ikun hemm bżonn ta' trasfużjonijiet tal-plejtlits, jekk indikat klinikament (ara sezzjoni 4.4).
English: If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
Maltese: Jekk tuża kontraċettiv ormonali, għandek tuża wkoll metodu ta' kontraċezzjoni li jimblokka (bħal kondom jew dijaframma).
English: EU/1/15/1023/004 6 capsules EU/1/15/1023/005 12 capsules EU/1/15/1023/006 24 capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1023/001 6 kapsuli
English: The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle.
Maltese: Id-doża inizjali rrakkomandata ta' panobinostat hi ta' 20 mg, meħuda mill-ħalq darba kuljum, fl-1el, it3et, il-5es, it-8n, l-10ar u fit-12-il ġurnata ta' kull ċiklu ta' 21 jum.
English: - After Week 3 you start a new cycle again as shown in Tables 1 and 2 below.
Maltese: • Wara t-3et ġimgħa terġa' tibda ċiklu ġdid kif muri fit-Tabelli 1 u 2 hawn taħt.
English: ≤1.0 x ULN >ULN Reduce panobinostat dose to 15 mg in the first treatment cycle.
Maltese: ≤1.0 x ULN >ULN Naqqas id-doża ta' panobinostat għal
English: Complete blood counts should be frequently monitored during treatment (in particular before each injection of bortezomib, i.e. on days 1, 4, 8 and 11 of cycles 1 to 8 and on days 1 and 8 of cycles 9 to 16), especially for thrombocytopenia (see section 4.4).
Maltese: L-għadd sħiħ taċ-ċelloli tad-demm għandu jkun evalwat b'mod frekwenti matul it-trattament (b'mod partikulari qabel kull injezzjoni ta' bortezomib, jiġifieri fil-jiem 1, 4, 8 u 11 taċ-ċikli 1 sa 8 u fil-jiem 1 u 8 taċ-ċikli 9 sa 16), b'mod speċjali għal tromboċitopenija (ara sezzjoni 4.4).
English: Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by
Maltese: panobinostat meta l-pazjent jirkupra għal grad 2 ta' tromboċitopenija (≥50 x 109/l)
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100)
English: The safety data reported below are based on the phase III clinical study (Panorama 1) in 381 patients with multiple myeloma treated with 20 mg panobinostat once a day three times per week, on a 2 weeks on and 1 week off dosing regimen in combination with bortezomib and dexamethasone.
Maltese: III (Panorama 1) fi 381 pazjent b'mijeloma multipla ttrattati b'20 mg panobinostat darba kuljum għal tliet darbiet fil-ġimgħa, fuq reġim ta' dożaġġ ta' ġimagħtejn iva u ġimgħa le flimkien ma' bortezomib u dexamethasone.
English: Modification of bortezomib starting dose
Maltese: Tibdil taddoża inizjali ta' bortezomib
English: Conjunctival haemorrhage
Maltese: Kompli bid-doża mnaqqsa
English: Studies in animals have shown reproductive and embryo-foetal toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva, l-embrijun u l-fetu (ara sezzjoni 5.3).
English: EU/1/15/1023/002 12 capsules EU/1/15/1023/003 24 capsules
Maltese: EU1/15/1023/002 12-il kapsula
English: o How to use the compliance card: this section provides a general overview on how to use the compliance card. o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card. o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit.
Maltese: o Tabella li tiddeskrivi r-reġim ta' trattament għal kull ġurnata taċ-ċiklu bi spazju fejn il-pazjent jista' jniżżel noti dwar il-mediċini li ħa.
English: Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Maltese: Analiżi addizzjonali wriet li r-riskju ta' titwil tal-QTc ma jiżdiedx matul il-medda taż-żmien (ara sezzjoni 4.2).
English: Pregnancy
Maltese: Kwalunkwe
English: • difficulty in breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with a red rash or raised bumps (potential signs of an allergic reaction)
Maltese: • uġigħ fl-istonku jew fl-addome, dardir, dijarea, rimettar, ippurgar iswed jew bid-demm, konstipazzjoni, ħruq ta' stonku, nefħa fl-addome (sinjali ta' problema gastrointestinali)
English: * Based on NCI-CTEP classification
Maltese: Titwil tal-QTc
English: Grade 3 despite anti-diarrhoeal medicinal product
Maltese: Grad 3 minkejja l-prodott mediċinali għal kontra d-dijarea
English: Liver function should be monitored prior to treatment and regularly during treatment as clinically indicated, especially in patients with hepatic impairment (see section 4.4).
Maltese: Għandu jsir monitoraġġ tal-funzjoni tal-fwied qabel ma jingħata t-trattament u għandu jibqa' jsir b'mod regolari waqt it-trattament kif indikat klinikament, b'mod speċjali f'pazjenti b'indeboliment talfwied (ara sezzjoni 4.4).
English: Grade 4 despite anti-diarrhoeal medicinal product
Maltese: Grad 4 minkejja l-prodott mediċinali għal kontra d-dijarea
English: The incidence of deaths not related to study indication was 8.8% in patients ≥65 years of age compared to 5.4% in patients <65 years of age.
Maltese: L-inċidenza ta' mwiet mhux relatata ma' xi indikazzjoni waqt l-istudju kienet ta' 8.8% f'pazjenti li kellhom ≥65 sena mqabbel mal-5.4% f'pazjenti li kellhom <65 sena.
English: Gastrointestinal haemorrhage, haematochezia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence
Maltese: Pressjoni għolja, ematoma, pressjoni baxxa ortostatika
English: - Store in the original package in order to protect from moisture.
Maltese: - Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Shock haemorrhagic
Maltese: Disturbi fl-għajnejn
English: • swollen ankles (a sign of a low level of albumin in the blood which is known as hypoalbuminaemia)
Maltese: • għekiesi minfuħin (sinjal ta' livell baxx ta' albumina fid-demm magħruf ukoll bħala ipoalbuminemija)
English: Patients with hepatic impairment
Maltese: Infezzjonijiet u infestazzjonijiet
English: Farydak is always used together with two other medicines: bortezomib and dexamethasone.
Maltese: Farydak jintuża dejjem flimkien ma' żewġ mediċini oħra: bortezomib u dexamethasone.
English: The platelet count should be ≥100 x 109/l and the absolute neutrophil count ≥1.0 x 109/l prior to initiation of treatment.
Maltese: Plejtlits 10 x 109/l terapija antifungali xierqa.
English: Package leaflet: Information for the patient Farydak 10 mg hard capsules
Maltese: IL-PRODOTT MEDIĊINALI Farydak 10 mg kapsuli iebsa
English: Women of childbearing potential taking panobinostat in combination with bortezomib and dexamethasone must use highly effective contraception for three months after stopping treatment (see sections 4.5 and 4.6 and bortezomib and dexamethasone SmPC).
Maltese: Nisa li jistgħu joħorġu tqal u li jkunu qegħdin jieħdu panobinostat flimkien ma' bortezomib u dexamethasone għandhom jużaw metodu mill-aktar effettiv ta' kontraċezzjoni għal tliet xhur wara li jwaqqfu t-trattament (ara sezzjonijiet 4.5 u 4.6 u s-SKP ta' bortezomib u dexamethasone).
English: When panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of hormonal contraceptives needs to be considered.
Maltese: Meta jingħata panobinostat flimkien ma' dexamethasone, li hu magħruf li hu induttur bejn dgħajjef u moderat ta' CYP3A4 kif ukoll ta' enzimi u trasportaturi oħrajn, wieħed għandu jikkunsidra r-riskju li tonqos l-effikaċja ta' kontraċettivi ormonali.
English: Table 9 Response rates in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent
Maltese: Tabella 9 Rati ta' rispons f'pazjenti bi mjeloma multipla li ngħataw mill-inqas żewġ reġimi minn qabel li jinkludu bortezomib u aġent immunomodulatorju
English: Due to the nature of multiple myeloma and the known haematotoxicity for panobinostat and its combination agent bortezomib, thrombocytopenia, often severe, has been frequently observed.
Maltese: Minħabba n-natura tal-mijeloma multipla u l-fatt magħruf ta' ematotossiċità b'panobinostat u l-aġent tiegħu ta' kombinazzjoni bortezomib, it-tromboċitopenija, ħafna drabi gravi, kienet osservata ta' spiss.
English: In the event of long QT interval prior to initiation of panobinostat (QTcF ≥480 msec at baseline), the start of treatment should be delayed until pre-dose average QTcF has returned to <480 msec.
Maltese: F'każ ta' intervall tal-QT twil qabel it-tnedija ta' panobinostat (QTcF ≥480 msek fil-linja bażi), ittnedija tat-trattament għandha tittardja sakemm il-medja tal-QTcF qabel id-doża terġa' lura għal <480 msek.
English: Hypothyroidism
Maltese: Emorraġija
English: - Do not take this medicine after the expiry date, which is stated on the carton and blister foil.
Maltese: - Tiħux din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja.
English: At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with an anti-diarrhoeal medicinal product (e.g. loperamide).
Maltese: Mal-ewwel indikazzjoni ta' wġigħ addominali, ippurgar maħlul jew bidu ta' dijarea, hu rrakkomandat li l-pazjent ikun ittrattat bi prodott mediċinali għal kontra d-dijarea (eż. loperamide).
English: The primary endpoint of the study was to assess overall response rate (ORR) after 8 cycles of therapy
Maltese: L-endpoint primarju tal-istudju kien li jevalwa r-rata ta' rispons ġenerali (overall response rate - ORR) wara 8 ċikli ta' terapija skont il-kriterji ta' mEBMT.
English: This summary was last updated in 06-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2017.
English: Onglyza saxagliptin
Maltese: Onglyza saksagliptina
English: The active substance in Onglyza, saxagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Onglyza, is-saksagliptina, hija inibitur tad-dipeptidil peptidażi 4 (DPP-4).
English: Regarding safety, Onglyza is generally well tolerated.
Maltese: Fir-rigward tas-sigurtà, Onglyza ġeneralment ġie tollerat sew.
English: Onglyza contains the active substance saxagliptin.
Maltese: Onglyza fih is-sustanza attiva saksagliptina.
English: The full EPAR for Onglyza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ' Onglyza jinsab fuq is medicine/Human medicines/European Public Assessment Reports.
English: Why is Onglyza approved?
Maltese: Għaliex ġie approvat Onglyza?
English: Onglyza is available as tablets (2.5 and 5 mg) and can only be obtained with a prescription.
Maltese: Onglyza jiġi bħala pilloli (2.5 u 5 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Adding dapagliflozin to metformin reduced HbA1c levels by 1.2 percentage points.
Maltese: Iż-żieda tad-dapagliflozina mal-metformina naqqset il-livelli ta' HbA1c b'1.2 punti perċentwali.
English: The recommended dose is 5 mg once a day.
Maltese: Id-doża rakkomandata hija ta' 5 mg darba kuljum.
English: What are the risks associated with Onglyza?
Maltese: X'inhuma r-riskji assoċjati ma' Onglyza?
English: The dose of Onglyza should be reduced to 2.5 mg once a day in patients with moderate or severe kidney problems.
Maltese: Id-doża ta' Onglyza għandha titnaqqas għal 2.5 mg darba kuljum f'pazjenti li jkollhom problemi moderati jew serji fil-kliewi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onglyza on 1 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Onglyza fl-1 ta' Ottubru 2009.
English: • In 534 patients not satisfactorily controlled with metformin alone, adding saxagliptin reduced HbA1c levels by around 0.9 percentage points and adding saxagliptin and dapagliflozin reduced HbA1c levels by 1.5 percentage points.
Maltese: • F'534 pazjent li ma kinux kontrollati b'mod sodisfaċenti bil-metformina biss, iż-żieda ta' saksagliptina naqqset il-livelli ta' HbA1c b'madwar 0.9 punti perċentwali u ż-żieda tas-saksagliptina u d-dapagliflozina naqqset il-livelli ta' HbA1c b'1.5 punti perċentwali.
English: Onglyza is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to control their blood glucose (sugar) level.
Maltese: Onglyza huwa mediċina kontra d-dijabete użata flimkien ma᾽ dieta u eżerċizzju għall-kura ta᾽ adulti bid-dijabete tat-tip 2 biex jikkontrollaw il-livell tal-glukożju (zokkor) tad-demm tagħhom.
English: • In 315 patients not satisfactorily controlled with metformin and dapagliflozin, adding saxagliptin to treatment with dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to dapagliflozin and metformin.
Maltese: • Fi 315-il pazjent li ma kinux ikkontrollati b'mod sodisfaċenti bil-metformina u d-dapagliflozina, iżżieda ta' saksagliptina mal-kura b'dapagliflozina u l-metformina naqqset il-livelli ta' HbA1c b'0.5 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.2 punti perċentwali meta plaċebo żdied maddapagliflozina u l-metformina.
English: • In 565 patients not satisfactorily controlled on a thiazolidinedione (diabetes medicines such as pioglitazone and rosiglitazone), HbA1c levels fell by around 0.9 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients who added placebo.
Maltese: • F'565 pazjent li ma kinux ikkontrollati b'mod sodisfaċenti bit-tiazolidinedione (mediċini tad-dijabete bħall-pioglitazone u rosiglitazone), il-livelli ta' HbA1c naqsu b'madwar 0.9 punti perċentwali f'pazjenti li żiedu s-saksagliptina meta mqabbel ma' tnaqqis ta' madwar 0.3 punti perċentwali f'pazjenti li żiedu l-plaċebo.
English: The most common side effects with Onglyza (seen in more than 5 patients in 100) are upper respiratory tract infection (nose and throat infection), urinary tract infection and headache.
Maltese: L-effett sekondarji l-iktar komuni b'Onglyza (li dehru f'iktar minn 5 pazjenti minn kull 100) huma infezzjonjiet fin-naħa ta' fuq tas-sistema respiratorja (infezzjonijiet fl-imnieħer u l-gerżuma), infezzjoni fl-apparat urinarju u wġigħ ta' ras.
English: Saxagliptin, the active substance in Onglyza, has been shown to be more effective than placebo (a dummy treatment) at controlling blood glucose in 8 main studies in over 3,900 patients.
Maltese: Is-saksagliptina, is-sustanza attiva f'Onglyza, intwera li kienet iktar effettiv mill-plaċebo (kura finta) filkontroll tal-glukożju tad-demm fi 8 studji ewlenin f'iktar minn 3,900 pazjent.
English: • In 320 patients not controlled with metformin and saxagliptin, adding dapagliflozin to saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Maltese: • Fi 320 pazjetn li ma kinux ikkontrollati b'mod sodisfaċenti bil-metformina u saksagliptina, iż-żieda ta' dapagliflozina mas-saksagliptina u l-metformina naqqset il-livelli ta' HbA1c b'0.8 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.1 punti perċentwali meta l-plaċebo żdied massaksagliptina u l-metformina.
English: • In 257 patients who took saxagliptin with metformin and a sulphonylurea, HbA1c levels fell by around 0.7 percentage points, compared with a fall of 0.1 percentage points in patients who were given placebo in place of saxagliptin.
Maltese: • F'257 pazjent li ħadu s-saksagliptina mal-metformina u s-sulfonilurea, il-livelli ta' HbA1c naqsu b'madwar 0.7 punti perċentwali, meta mqabbel ma' tnaqqis ta' madwar 0.1 punti perċentwali f'pazjenti li żiedu l-plaċebo minflok is-saksagliptina.
English: HbA1c levels were around 8% at the start of the study.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c kienu madwar 8%.
English: HbA1c levels were on average around 9% at the start of the study.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c kienu bħala medja madwar 9%.
English: How is Onglyza used?
Maltese: Kif jintuża Onglyza?