FrancophonIA/ELRC3.0 huggingface dataset:
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥ 50% reduction of CRK-like (CRKL) phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Maltese: ≥ 50% ta' fosforilazzjoni bħal ta' CRK (CRK-like, CRKL), markatur bijoloġiku ta' impediment ta' BCR-ABL, fiċ-ċelluli mononukleari ta' demm periferali.
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased, hyponatraemia
Maltese: Komuni deidratazzjoni, żamma ta' fluwidu, ipokalċemija, ipergliċemija, iperuriċemija, ipofosfatemija, ipertrigliċeridemija,
English: Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Maltese: Reazzjonijiet tromboemboliċi venużi serji avversi ġew osservati f'5% tal-pazjenti (frekwenzi li tfaċċaw minħabba trattament) (ara sezzjoni
English: • blurred vision, dry eye, infection in the eye, visual disturbance
Maltese: • vista mċajpra, għajn tinħass xotta, infezzjoni fl-għajn, disturb fil-vista
English: Hypertension may contribute to risk of arterial occlusive events.
Maltese: Pressjoni għolja tista' tikkontribwixxi għal riskju ta' avvenimenti okklużivi fl-arterji.
English: Occurrence at 15 mg:
Maltese: F'każ li jseħħ bi 15 mg:
English: Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion
Maltese: Mhux komuni trombożi fil-vina tar-retina, okklużjoni tal-vina tar-retina, okklużjoni tal-arterja tar-retina
English: In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies).
Maltese: Fil-prova ta' fażi 2 (b'minimu ta' follow-up ta' 64 xahar), reazzjonijiet okklussivi avversi fl-arterji seħħew f'25% tal-pazjenti (frekwenzi li ħarġu mal-kura).
English: Based on the Kaplan-Meier estimates, 82% (95% CI: [74%-88%]) of CP-CML (median duration of treatment: 32.2 months) patients who achieved a MCyR are projected to maintain that response at 48 months and 61% (95% CI: [51%- 70%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 36 months.
Maltese: 32.2 xahar) li kisbu MCyR huma proġettati li jżommu r-rispons għal 48 xahar u 61% (95% CI: [51%- 70%])
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively.
Maltese: Reazzjonijiet avversi okklussivi vaskulari serji fl-arterji kardjovaskulari, ċerebrovaskulari, u periferali (frekwenzi li ħarġu mal-kura) seħħew f'10%, 7%, u 9% tal-pazjenti kkurati b'Iclusig, rispettivament.
English: Resistant or Intolerant R/I Cohort (N=10)
Maltese: Koorti R/I (N=10)
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets ponatinib
Maltese: Iclusig 45 mg pilloli miksija b'rita Ponatinib
English: Following a single oral dose of [14C]-labeled ponatinib, approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Maltese: Wara doża orali waħda ta' ponatinib [14C] tikkettat, madwar 87% tad-doża radjuattiva hija rikoverata fl-ippurgar u madwar 5% fl-awrina.
English: Unchanged ponatinib accounted for 24% and < 1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Maltese: < 1% tad-doża amministrata fl-ippurgar u l-awrina rispettivament, bil-kumplament tad-doża tikkomprendi metaboliti.
English: In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
Maltese: Fil-prova ta' fażi 2, reazzjonijiet okklussivi avversi serji fl-arterji seħħew f'20% tal-pazjenti (frekwenzi li ħarġu mal-kura).
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Maltese: Fliexken ta' densità għolja ta' polyethylene (HDPE) b'għotjien bil-kamin, li fihom 30, 60 jew 180 pillola miksija b'rita, flimkien ma' kontenitur wieħed tal-plastik li fih desikkant li jgħarbel il molekuli.
English: NAME OF THE MEDICINAL PRODUCT Iclusig 30 mg film-coated tablets ponatinib
Maltese: Iclusig 30 mg pilloli miksija b'rita Ponatinib
English: How to store Iclusig
Maltese: X'fih Iclusig
English: Hepatotoxicity
Maltese: Ponatinib
English: • Iclusig should be withheld and resumed at 30 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 30 mg:
Maltese: Okkorrenza mill-ġdid b'30 mg: • Iclusig għandu jiġi mwaqqaf u jerġa' jiġi mibdi bi 15 mg wara l-irkupru sakemm ANC ≥ 1.5 x 109/L u plejtlets ≥ 75 x 109/L
English: INFORMATION IN BRAILLE Outer Carton:
Maltese: Kartuna ta' Barra:
English: Iclusig is for oral use.
Maltese: Użu orali.
English: Intrinsic factors affecting ponatinib pharmacokinetics No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Maltese: Fatturi intrinsiċi li jaffettwaw il-farmakokinetika ta' ponatinib Ma sarux studji speċifiċi biex jevalwaw l-effetti tas-sess, età, razza, u piż tal-ġisem fuq il-farmakokinetika ta' ponatinib.
English: In addition, results from logistic regression analyses of data from patients in the phase 1 trial, suggest a relationship between systemic exposure (AUC) and occurrence of arterial thrombotic events.
Maltese: riżultati minn analiżi ta' rigressjoni loġistika ta' dejta minn pazjenti fil-prova ta' fażi 1, tissuġġerixxi relazzjoni bejn l-esponiment sistemiku (AUC) u l-okkorrenza ta' avvenimenti trombotiċi fl-arterji.
English: Table 3 Recommended dose modifications for hepatic toxicity Elevation of liver transaminase > 3 × ULN*
Maltese: Tabella 3 Modifiki rakkomandati tad-doża għal tossiċità fil-fwied
English: • hot flush, flushing
Maltese: • sirdat, mard jixbaħ lill-influwenza
English: Caution is recommended when administering Iclusig to patients with hepatic impairment (see sections 4.2 and 4.4).
Maltese: Kawtela hija rakkomandata meta Iclusig jingħata lil pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Maltese: Tabella 7 L-effikaċja ta' Iclusig f'pazjenti li huma reżistenti jew intolleranti għal CML
English: Each 30 mg film-coated tablet contains 30 mg ponatinib (as ponatinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 30 mg ponatinib (bħala hydrochloride).
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets ponatinib
Maltese: Iclusig 15 mg pilloli miksija b'rita Ponatinib
English: Common rash pruritic, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative, hyperkeratosis, skin hyperpigmentation
Maltese: Komuni raxx bilħakk, raxx bil-qxur, eritema, alopeċja, tqaxxir tal-ġilda, għaraq bil-lejl, iperidrożi, tbenġil, ekkimożi, uġigħ tal-ġilda,
English: Iclusig has not been studied at doses above 30 mg in patients with hepatic impairment (Childs-Pugh Classes A, B & C).
Maltese: Iclusig ma ġiex studjat f'dożi ogħla minn 30 mg f'pazjenti b'indeboliment tal-fwied (Klassijiet A, B u
English: For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression, arthralgia) over the dose range of 15 to 45 mg once-daily.
Maltese: pressjoni għolja, tromboċitopenija, pankreatite, newtropenija, raxx, żieda fl-ALT, żieda fl-AST, żieda fil-lipase, majelosoppressjoni, artralġja) fuq il-firxa ta' doża ta' 15 sa 45 mg darba kuljum.
English: Co-administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Maltese: John's Wort flimkien ma' ponatinib għandu jiġi evitat, u għandhom jiġu mfittxija alternattivi għall-induttur ta' CYP3A4, sakemm il-benefiċċju ma jkunx akbar mir-riskju possibbli ta' nuqqas ta' esponiment għal ponatinib.
English: The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Maltese: L-inċidenza ta' każijiet severi ta' fsada kienet ogħla f'pazjenti b'AP-CML, BP-CML u Ph+ ALL.
English: Common pneumonia, sepsis, folliculitis, cellulitis
Maltese: Komuni pulmonite, sepsi, follikulite, ċellulite
English: Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Maltese: Pazjenti b'indeboliment tal-fwied jistgħu jirċievu d-doża rakkomandata tal-bidu.
English: A majority of these ongoing patients (82/110 patients; 75%) were reported to be receiving 15 mg at the last dose, while 24/110 patients (22%) were receiving 30 mg, and 4/110 (4%) were receiving 45 mg. At the time of study closure initiation (minimum follow-up of 64 months, and more than 3 years after the recommendation for prospective dose reduction), 99 CP-CML patients were ongoing and 77 (78%) of these patients received 15 mg as their last dose on study.
Maltese: Il-maġġoranza ta' dawn il-pazjenti li baqgħu għadejjin (82/110 pazjenti; 75%) kienu rapportati li qed jirċievu 15 mg fl-aħħar doża, waqt li 24/110 pazjenti (22%) kienu qed jirċievu 30 mg, u 4/110(4% kienu qed jirċievu 45 mg).
English: It is unknown whether Iclusig is excreted in human milk.
Maltese: dożi li jikkorrispondu għal esponimenti kliniċi umani.
English: Arterial occlusion adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Maltese: Avvenimenti avversi ta' okklużjoni arterjali kienu aktar frekwenti b'żieda fl-età u f'pazjenti bi storja ta' iskemija, pressjoni għolja, dijabete, jew iperlipidemija.
English: Biochemistry
Maltese: Il-Ġermanja
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4.
Maltese: Lista f'forma tabulari ta' reazzjonijiet avversi Reazzjonijiet avversi rrappurtati fil-pazjenti kollha b'CML u Ph+ ALL huma ppreżentati fit-Tabella 4.
English: Carriers of HBV who require treatment with Iclusig should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: Portaturi tal-HBV li jeħtieġu l-kura b'Iclusig għandhom jiġu mmonitorjati mill-qrib għal sinjali u għal sintomi tal-infezzjoni attiva tal-HBV waqt ilkura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: • Keep this leaflet.
Maltese: • tnaqqis fl-aptit • nuqqas ta' rqad
English: Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors.
Maltese: Reazzjonijiet severi tal-ġilda (bħas-Sindrome ta' Stevens-Johnson) ġew irrappurtati ma' xi Inibituri
English: Very common alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Komuni ħafna żieda ta' alanine aminotransferase, żieda ta'
English: CYP3A inhibitors
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: Efficacy results are summarized in Table 7, Table 8, and Table 9.
Maltese: Ir-riżultati tal-effikaċja huma miġbura fil-qosor f'Tabella 7, Tabella 8 u Tabella 9.
English: For a dose of 30 mg or 15 mg once daily, 15 mg and 30 mg film-coated tablets are available.
Maltese: Għal doża ta' 30 mg jew 15 mg darba kuljum, pilloli miksija b'rita ta' 15 mg u 30 mg huma disponibbli.
English: Iclusig contains lactose
Maltese: Tiblax il-kontenitur bid-desikkant.
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Maltese: Lesperti fil-mard tal-fwied u fil-kura tal-epatite B għandhom jiġu kkonsultati qabel ma tibda l-kura f'pazjenti b'seroloġija pożittiva tal-epatite B (inklużi dawk bil-marda attiva) u għal dawk il-pazjenti li nstabu pożittivi għall-infezzjoni tal-HBV matul il-kura.
English: ≥ 36 month reduction at 15 mg 8
Maltese: ≥ 3 xhur ta' tnaqqis għal 15 mg
English: PRES is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances.
Maltese: PRES huwa disturb newroloġiku li jista' jippreżenta ruħu permezz ta' sinjali u sintomi bħal aċċessjoni, uġigħ ta' ras, viġilanza mnaqqsa, tibdil fil-funzjoni mentali, telf ta' vista, u disturbi newroloġiċi u viżwali oħra.
English: Iclusig belongs to a group of medicines called tyrosine kinase inhibitors.
Maltese: BCR-ABL Tyrosine Kinase.
English: Leukopenia (WBC decreased)
Maltese: Newtropenja (tnaqqis fl-ANC) Leukopenia (WBC imnaqqsa) Anemija (Hgb imnaqqas) Limfopenija
English: • recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Maltese: • rikorrenza (riattivazzjoni) tal-infezzjoni tal-epatite B meta kellek l-epatite B fil-passat
English: See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.
Maltese: Ara sezzjonijiet 4.2 għall-valutazzjoni tal-istat kardjovaskulari qabel il-bidu tat-terapija u 4.4 għal sitwazzjonijiet fejn kura alternattiva tista' tiġi kkunsidrata.
English: • Contraceptive advice for men and women Women of childbearing age being treated with Iclusig should avoid becoming pregnant.
Maltese: • Pariri dwar kontraċezzjoni għall-irġiel u n-nisa Nisa ta' età li jista' jkollhom it-tfal li jkunu qed jiġu kkurati b'Iclusig għandhom jevitaw li joħorġu tqal.
English: Iclusig should be interrupted immediately in case of arterial occlusion.
Maltese: Iclusig għandu jitwaqqaf immedjatament f'każ ta' okklużjoni arterjali.
English: Also, post-hoc analyses to assess the relationship of shorter-term cytogenetic (MCyR) and molecular (MMR) response outcomes with longer-term outcomes of PFS and OS, maintenance of response (MCyR and MMR) after dose reductions, and PFS and OS by Arterial Occlusive Event status were conducted.
Maltese: Minbarra hekk, saru analiżi post-hoc li analizzaw ir-relazzjoni ta' riżultati ta' rispons ċitoġeniku (MCyR) u molekulari (MMR) fuq perijodu ta' żmien qasir mqabbla ma' riżultati fuq terminu ta' żmien itwal għal PFS u OS, żamma ta' rispons (MCyR u MMR) wara tnaqqis fid-doża, u PFS u OS bl-istat tal Każ Okklużiv Arterjali.
English: Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 45 mg ponatinib (bħala hydrochloride).
English: • Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
Maltese: • Iclusig għandu jiġi mwaqqaf u l-funzjoni fil-fwied għandha tiġi mmonitorjata • Iclusig għandu jitkompla f'doża ta' 30 mg wara l-irkupru għal ≤ Grad 1 (< 3 × ULN), jew irkupru fi grad ta' qabel it-trattament
English: Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Maltese: ċ MCyR jikkombina risponsi ċitoġenetiċi kemm kompluti (l-ebda ċellula Ph+ osservata) kif ukoll parzjali (1% sa 35% ċelluli Ph+).
English: • renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Maltese: • stenosi tal-arterja renali (tidjiq tal-vażi tad-demm għal kilwa waħda jew it-tnejn)
English: • headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
Maltese: • uġigħ ta' ras, konfużjoni, aċċessjonijiet, u telf ta' vista, li jistgħu jkunu sintomi ta' kundizzjoni tal-moħħ magħrufa bħala sindrome ta' enċefalopatija posterjuri riversibbli (PRES).
English: ≥ 12 month reduction at 15 mg 44
Maltese: ≥ 12-il xahar ta' tnaqqis għal 15 mg
English: • changes in blood levels: decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue) decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise) decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) increased level of the serum protein known as lipase
Maltese: - tnaqqis fl-għadd ta' plejtlits fid-demm (sintomi jinkludu: tendenza ogħla li tinfasad jew titbenġel) - tnaqqis fl-għadd ta' ċelluli bojod tad-demm li jissejħu newtrofili (sintomi jinkludu:
English: • low calcium, phosphate or potassium levels in the blood
Maltese: • żamma ta' fluwidu • livelli baxxi ta' kalċju, fosfat jew potassju fid-demm
English: Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats.
Maltese: Bidliet iper/ipoplastiċi tal-chondrocytes fil-physis ġew innotati fi studji dwar it-tossiċità minħabba dożi ripetuti fil-firien.
English: • mini stroke
Maltese: • stitikezza
English: Very common rash, dry skin, pruritus
Maltese: Komuni ħafna raxx, ġilda xotta, ħakk
English: Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 55.5 months (range: 1.7 to 91.4 months).
Maltese: Minn 43 pazjent b'CP-CML, 31 pazjent b'CP-CML kisbu MCyR bi żmien medjan ta' insegwitu ta' 55.5 xahar (medda: 1.7 sa
English: Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Maltese: Emorraġija gastrointestinali u ematoma sottodurali kienu l-aktar avvenimenti ta' fsada ta' grad 3/4 irrappurtati b'mod komuni.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: Iswed/Amerikan-Affrikan Abjad
English: What Iclusig contains
Maltese: Iclusig ma' ikel u xorb
English: • a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
Maltese: • pillola miksija b'rita ta' 15 mg u pillola miksija b'rita ta' 30 mg sabiex tippermetti aġġustament tad-doża.
English: Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone.
Maltese: induttur qawwi ta' CYP3A, lil 19-il voluntier f'saħħithom, naqqas l-AUC0-∞ u Cmax ta' ponatinib b'62% u 42%, rispettivament, meta mqabbel mal-għoti ta' ponatinib waħdu.
English: • skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
Maltese: • raxx tal-ġilda, tqaxxir tal-ġilda, tħaxxin abnormali tal-ġilda, ħmura, tbenġil, uġigħ fil-ġilda,
English: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side.
Maltese: Pillola miksija b'rita ta' lewn bajda, mżaqqa fuq iż-żewġ naħat li ta' madwar 9 mm dijametru, b'“AP4” intaljat fuq naħa minnhom.
English: EMA/790269/2014 EMEA/H/C/001234
Maltese: EMEA/H/C/001234
English: The full EPAR for Ristaben can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ristaben sitagliptin
Maltese: Sitagliptina
English: The active substance in Ristaben, sitagliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Maltese: Is-sustanza attiva f'Ristaben, is-sitagliptina, hija inibitur tad-dipeptidil-peptidażi-4 (DPP 4).
English: Ristaben is taken at a dose of 100 mg once a day.
Maltese: Ristaben jittieħed f'doża ta' 100 mg darba kuljum.
English: Serious side effects reported with Ristaben include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Maltese: L-effetti sekondarji serji li ġew irrapportarti bl-użu ta' Ristaben inkludew pankreatite (infjamazzjoni talfrixa) u ipersensittività (reazzjonijiet allerġiċi).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristaben on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ristaben fil-15 ta' Marzu 2010.
English: • three additional studies compared Ristaben with placebo when they were added to other diabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Maltese: • tliet studji oħra qabblu Ristaben ma' plaċebo meta żdiedu ma' mediċini oħrajn tad-dijabete: ilglimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, fuq 441 pazjent; it-taħlita talmetformina u r-rosiglitażonu (agonista PPAR gamma) fuq 278 pazjent; u doża stabbli ta' insulina, bil-metformina jew mingħajrha, fuq 641 pazjent.
English: Ristaben is a diabetes medicine that contains the active substance sitagliptin.
Maltese: Ristaben huwa mediċina tad-dijabete li fiha s-sustanza attiva s-sitagliptina.
English: Ristaben or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Maltese: Ristaben jew plaċebo ntużaw waħedhom f'żewġ studji fuq 1,262 pazjent, bħala żieda mal-metformina fi studju wieħed fuq 701 pazjent, u bħala żieda mal-pijoglitażonu (agonist PPAR-gamma) fi studju fuq 353 pazjent;
English: This is a summary of the European Public Assessment Report (EPAR) for Ristaben.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ristaben.
English: Finally, they were reduced by 0.59% in patients adding Ristaben to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Maltese: Fl-aħħar, tnaqqsu b'0.59% f'pazjenti li żiedu Ristaben mal-insulina (bil-metaformina jew mingħajrha), meta mqabbel ma' tnaqqis ta' 0.03% f'dawk li żiedu l-plaċebo.
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Ristaben to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Maltese: Il-livelli tal-HbA1c tnaqqsu b'1.03% wara 18-il ġimgħa f'pazjenti li żiedu Ristaben malmetformina u r-rosiglitażonu, apparagun ma' tnaqqis ta' 0.31% f'dawk li żiedu l-plaċebo.
English: When added to pioglitazone, Ristaben reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Maltese: Meta miżjud mal-pijoglitażonu, Ristaben naqqas il-livelli tal-HbA1c b'0.85% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.15% f'pazjenti li żiedu l-plaċebo.
English: One study compared Ristaben with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Maltese: Studju minnhom qabbel Ristaben mal-glipiżide (sulfonilurea), meta intużaw bħala żieda mal-metformina f'1,172 pazjent.
English: What is Ristaben?
Maltese: X'inhu Ristaben?
English: When taken on their own, Ristaben and metformin produced similar reductions in HbA1c levels, but the effectiveness of Ristaben seemed to be slightly lower than that of metformin.
Maltese: Meta ttieħdu waħedhom, Ristaben u l-metformina pproduċew tnaqqis simili fil-livelli tal-HbA1c, iżda l-effikaċja ta' Ristaben dehret li kienet ftit inqas minn dik tal-metformina.
English: In the additional studies, adding Ristaben to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Maltese: Fl-istudji ulterjuri, iż-żieda ta' Ristaben mal-glimepiride (bil-metformina jew mingħajrha) ikkaġunat tnaqqis fil-livelli tal-HbA1c ta' 0.45% wara 24 ġimgħa, apparagun ma' żieda ta' 0.28% fil-pazjenti li żiedu l-plaċebo.