FrancophonIA/ELRC3.0 huggingface dataset:
English: TREVICTA 175 mg prolonged release suspension for injection paliperidone
Maltese: TREVICTA 175 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni paliperidone
English: If administering a Gluteal injection
Maltese: Jekk se tagħti injezzjoni Gluteali
English: TREVICTA 350 mg prolonged release suspension for injection paliperidone
Maltese: TREVICTA 350 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni paliperidone
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: Sinjali kliniċi oħrajn jistgħu jinkludu mijoglubinurja (rabdomijoliżi) u insuffiċjenza akuta tal-kliewi.
English: Ear and labyrinth disorders vertigo, tinnitus, ear pain
Maltese: Disturbi filwidnejn u fissistema labirintika vertigo, żanżin filwidnejn, uġigħ filwidna
English: Each pre-filled syringe contains paliperidone palmitate equivalent to 263 mg paliperidone.
Maltese: Kull siringa mimlija għal-lest fiha paliperidone palmitate ekwivalenti għal 263 mg paliperidone.
English: • accumulation of pus caused by infection at injection site, deep skin infection, a cyst at the injection site, bruising at injection site.
Maltese: • akkumulazzjoni ta' materja kkawżata minn infezzjoni fil-post tal-injezzjoni, infezzjoni fil-fond fil-ġilda, ċesta fil-post tal-injezzjoni, tbenġil fil-post tal-injezzjoni.
English: Intraoperative floppy iris syndrome
Maltese: Reazzjoni avversa għall-mediċina Frekwenza
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Maltese: Billi jiddomina l-antagoniżmu b'mod ċentrali tas-serotonin jista' jnaqqas it-tendenza ta' paliperidone li jikkawża effetti ekstrapiramidali.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Maltese: Bil-mod u b'attenzjoni imbotta l-virga tal-planġer 'l fuq biex tneħħi l-arja.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in subjects treated with 1-monthly paliperidone palmitate injectable compared to a rate of 0.39% in placebo group.
Maltese: Fi provi kkontrollati bi plaċebo, dijabete mellitus kienet irrappurtata f'0.32% tal-individwi ttrattati b'paliperidone palmitate kull xahar li jista' jiġi injettat meta mqabbla ma' rata ta' 0.
English: TREVICTA has not been systematically studied in patients with renal impairment.
Maltese: TREVICTA ma ġiex studjat b'mod sistematiku f'pazjenti b'indeboliment tal-kliewi.
English: Population pharmacokinetics analysis showed no evidence of race related pharmacokinetics differences.
Maltese: Analiżi farmakokinetiċi tal-popolazzjoni ma wrew l-ebda xhieda ta' differenzi farmakokinetiċi marbuta mar-razza.
English: TREVICTA should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Maltese: TREVICTA m'għandux jintuża sabiex jikkontrolla stati ta' aġitazzjoni akuta jew stati psikotiċi severi meta jkun meħtieġ kontroll immedjat tas-sintomi.
English: • For those ≥ 90 kg, the thin wall 1½ inch, 22 gauge (0.72 mm x 38.1 mm) needle should be used.
Maltese: • Għal dawk ≥ 90 kg, għandha tintuża l-labra magħmula minn materjal irqiq ta' pulzier u nofs,
English: Patients treated with TREVICTA should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Il-pazjenti ttrattati bi TREVICTA għandhom jiġu mmonitorjati għal sintomi ta' ipergliċemija (bħal polidipsja, poliurja,polifaġja, u dgħufija) u pazjenti b'dijabete mellitus għandhom jiġu mmonitorjati b'mod regolari għal kontroll talglukows li jmur għall-agħar.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Maltese: Din il-mediċina tista' tnaqqas l-effett ta' mediċini kontra l-marda ta' Parkinson u s-sindrom ta' nuqqas ta' kwiet fir-riġlejn (eż., levodopa).
English: The mean changes in body weight from double-blind baseline to double-blind end point were +0.94 kg and -1.28 kg for the TREVICTA and placebo groups, respectively.
Maltese: Il-bidliet medji fil-piż tal-ġisem mil-linja bażi sal-iskop finali fejn la linvestigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienu +0.94 kg u-1.28 kg għall-gruppi ta' TREVICTA u tal-plaċebo, rispettivament.
English: The needle to be used for administration of TREVICTA into the gluteal muscle is the thin wall 1½ inch, 22 gauge (0.72 mm x 38.1 mm) needle regardless of body weight.
Maltese: 72 mm x 38.1 mm) u labra ta' sigurtà magħmula minn materjal irqiq ta' 22G u pulzier (0.
English: Potential for other medicines to affect TREVICTA
Maltese: Il-potenzjal ta' TREVICTA li jaffettwa mediċini oħra
English: In the long-term randomised withdrawal study, abnormal increases of ≥ 7% in body weight from double-blind baseline to double-blind end point were reported for 10% subjects in the TREVICTA group and 1% subjects in the placebo group.
Maltese: Fl-istudju fit-tul ta' waqfien tal-mediċina fejn il-pazjenti ntgħażlu b'mod arbitrarju, żidiet mhux normali ta' ≥ 7% fil-piż tal-ġisem mill-linja bażi sal-iskop finali fejn la l-investigaturi u lanqas l individwi ma kienu jafu liema sustanza qed tintuża, ġew irrappurtati għal 10% tal-individwi fil-gruppta' TREVICTA u 1% tal-grupp tal-plaċebo.
English: Co-administration of a single dose of an oral paliperidone prolonged release tablet 12 mg with divalproex sodium prolonged release tablets (two 500 mg tablets once daily) resulted in an increase of approximately 50% in the Cmax and AUC of paliperidone, likely as a result of increased oral absorption.
Maltese: L-għoti ta' doża waħda mill-ħalq ta' pillola ta' 12-il mg ta' paliperidone li terħi l-mediċina bil-mod flimkien mal-pilloli ta' divalproex sodium li jerħu l-mediċina bil-mod (żewġ pilloli ta' 500 mg darba kuljum) wassal għal żieda ta' madwar 50% fis-Cmax u l-AUC ta' paliperidone, aktarx minħabba żieda fl-assorbiment orali.
English: • muscle spasms, joint stiffness, muscle weakness, neck pain
Maltese: żieda fid-dmugħ, ħmura fl-għajnejn
English: The exposure range for TREVICTA is encompassed within the exposure range for the approved dose strengths of paliperidone prolonged release tablets.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Peel off the tab label from the syringe and place in patient record.
Maltese: Qaxxar it-tikketta ta' identifikazzjoni minn mas-siringa u poġġiha fir-rekords tal-pazjent.
English: oedema e, body temperature increased, gait abnormal, chest pain, chest discomfort, malaise, induration hypothermia, chills, thirst, drug withdrawal syndrome, injection site abscess, injection site cellulitis, injection site cyst, injection site haematoma body temperature decreased, injection site necrosis, injection site ulcer
Maltese: żieda fit-temperatura tal-ġisem, mixi mhux normali, uġigħ fis-sider, skumdità fis-sider, telqa tal-ġisem mingħajr sinjali ta' mard, ebusija ipotermja, tkexkix ta' bard, għatx, sindrom ta' twaqqif ta' mediċina li tivvizzja, axxess fil-post talinjezzjoni, ċellulite fil-post talinjezzjoni, ċesta filpost tal-injezzjoni, ematoma fis-sit talinjezzjoni tnaqqis fittemperatura talġisem, nekrożi filpost talinjezzjoni, ulċera fil-post talinjezzjoni
English: Figure 2: Kaplan-Meier plot of time to relapse comparing TREVICTA and 1-monthly paliperidone palmitate injectable
Maltese: Figura 2: Plot Kaplan-Meier taż-żmien għar-rikaduta li tqabbel TREVICTA u paliperidone palmitate ta' kull xahar li jista' jiġi injettat
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Maltese: Dan it-tnaqqis huwa kkawżat, fil-parti l-kbira, minn żieda ta' 35% fit-tneħħija ta' paliperidone mill-kliewi aktarx minħabba l-induzzjoni ta' P-gp tal-kliewi b'carbamazepine.
English: The combined use of psychostimulants (e.g. methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Maltese: L-użu ta' psikostimulanti (eż., methylphenidate) flimkien ma' paliperidone jista' jwassal għal sintomi ekstrapiramidali meta jkun hemm bidla fi trattament wieħed jew fit-tnejn li huma (ara sezzjoni 4.4).
English: Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Maltese: Għalkemm studji in vitro issuġġerew li CYP2D6 u CYP3A4 għandhom sehem fil-metaboliżmu ta' paliperidone, m'hemmx evidenza in vivo li dawn l-isozimi għandhom sehem sinifikanti fil-metaboliżmu ta' paliperidone.
English: Co-administration of oral paliperidone prolonged release once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Maltese: L-għoti darba kuljum mill-ħalq ta' paliperidone li jintreħa bil-mod ma' 200 mg ta' carbamazepine darbtejn kuljum ikkawża tnaqqis ta' madwar 37% fil-medja tas-Cmax u l-AUC ta' paliperidone fl-istat fiss.
English: Musculoskeletal and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, muscular weakness, neck pain rhabdomyolysis, joint swelling posture abnormal
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi uġigħ muskoluskeletriku, uġigħ fid-dahar, artralġja żieda fil-creatine phosphokinase fiddemm, spażmi filmuskoli, ebusija filġogi, dgħufija filmuskoli, uġigħ fl-għonq rabdomijolisi, nefħa fil-ġogi qagħda mhux normali
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with TREVICTA and preventative measures undertaken.
Maltese: Minħabba li pazjenti ttrattati b'antipsikotiċi ta' spiss ikollhom fatturi ta' riskju akkwistati għal VTE, il-fatturi kollha ta' riskju għal VTE għandhom jiġu identifikati qabel u waqt il-kura bi TREVICTA u għandhom jittieħdu miżuri ta' prevenzjoni.
English: • experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
Maltese: • ikollok allerġija severa kkaratterizzata minn deni, nefħa fil-ħalq, fil-wiċċ, fix-xufftejn jew flilsien, qtugħ ta' nifs, ħakk, raxx fil-ġilda u xi kultant tnaqqis fil-pressjoni tad-demm (li huma ekwivalenti għal ‘reazzjoni anafilattika').
English: Eye disorders vision blurred, conjunctivitis, dry eye glaucoma, eye movement disorder, eye rolling, photophobia, lacrimation increased, ocular hyperaemia floppy iris syndrome (intraoperative)
Maltese: Disturbi flgħajnejn vista mċajpra, konġuntivite, għajn xotta glawkoma, disturb fiċ-ċaqliq talgħajnejn, qlib talgħajnejn, fotofobja, żieda fid-dmugħ, iperimja fl-għajn sindrom tal-ħabba li tiċċaqlaq (intraoperattiv)
English: In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Maltese: Il-konċentrazzjonijiet ta' paliperidone fil-plażma jiżdiedu f'pazjenti b'indeboliment tal-kliewi.
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Maltese: Ġew identifikati erba' mogħdijiet metaboliċi in vivo, li l-ebda waħda minnhom ma kienet responsabbli għal iktar minn 10 % tad-doża: dealkilazzjoni, idroksilazzjoni, deidroġenazzjoni, u xizzjoni tal-benzisoxazole.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Maltese: Il-manifestazzjoni ta' din iż-żieda fis-sensittività tista' tinkludi konfużjoni, tnaqqis kbir fil-livell ta' koxjenza, instabilità fil-qagħda li twassal għal waqgħat frekwenti, flimkien ma' sintomi ekstrapiramidali.
English: Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), TREVICTA should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Maltese: Meta wieħed iqis l-effetti primarji fuq is-sistema ċentrali nervuża (CNS - central nervous system) ta' paliperidone (ara sezzjoni 4.8), TREVICTA għandu jintuża b'kawtela meta jittieħed flimkien ma' prodotti mediċinali oħra li għandhom azzjoni ċentrali eż. anksjolitiċi, il-biċċa l-kbira tal-antipsikotiċi, ipnotiċi, opjojdi, eċċ. jew l-alkoħol.
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt 25C.
English: Subjects with events n (%)
Maltese: Individwi b'avvenimenti n (%)
English: Placebo (N=8212)
Maltese: Plaċebo (N=8212)
English: Tablet core Povidone K30
Maltese: Povidone K30
English: • Tablet core: povidone K30, magnesium stearate.
Maltese: • Il-qalba tal-pillola: povidone K30, magnesium stearate.
English: The mean Vd ranged between 63-276 L.
Maltese: Ilmedja ta' Vd kienet f'medda ta' bejn 63-276 L.
English: Posology Adults with normal renal function (GFR ≥ 90 mL/min)
Maltese: Pożoloġija Adulti b'funzjoni renali normali (GFR≥90 mL/min)
English: * (uncommon), myalgia
Maltese: * (mhux komuni), mijalġja
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje
English: Reductions in A1c were seen across subgroups including gender, age, race, and baseline BMI.
Maltese: Tnaqqis flA1c deher fost is-sottogruppi b'sess, età, razza, u BMI mal-linja bażi.
English: The corresponding plasma Cmax values were 24 ng/mL and 47 ng/mL, respectively.
Maltese: Il-valuri ta' Cmax korrispondenti filplażma kienu 24 ng/mL u 47 ng/mL, rispettivament.
English: • Printing ink: shellac, indigo carmine aluminium lake (E132).
Maltese: • Linka tat-timbru: 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 tiegħu la inibixxew CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A4 u l-anqas induċew CYP1A2, 2B6, 2C9, jew 3A4.
English: HbA1c (%) at week 24
Maltese: HbA1c (%) f'ġimgħa 24
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Maltese: LRM = Miżuri repetuti lonġitudinali (Longitudinal repeated measures) (bl-użu ta' valuri qabel is-salvataġġ).
English: Komboglyze with alcohol
Maltese: Komboglyze mal-alkoħol
English: Difference from dapagliflozin + metformin (adjusted mean (95% CI)
Maltese: Differenza minn dapagliflozin + metformin (medja aġġustata (95 % CI)
English: The active substances are saxagliptin and metformin hydrochloride.
Maltese: Is-sustanzi attivi huma saxagliptin u metformin hydrochloride.
English: Hazard Ratio (95% CI)
Maltese: Proporzjon ta' periklu (95% CI)
English: • liver problems (hepatitis)
Maltese: • problemi fil-fwied (epatite)
English: Gastrointestinal disorders Gastrointestinal symptoms
Maltese: Disturbi gastro-intestinali Sintomi gastrointestinali
English: • Film-coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172).
Maltese: • Kisja tar-rita: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b),
English: Acute pancreatitis
Maltese: Pankrejatite akuta
English: Multipacks containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in non-perforated blisters.
Maltese: Pakketti multipli li jkun fihom 112 (2 pakketti ta` 56) u 196 (7 pakketti ta` 28) pilloli miksijin b'rita ġo folji mhux imtaqqbin.
English: The adverse reactions are listed by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skond is-sistema ta' klassifikazzjoni tal-organi u frekwenza assoluta.
English: Other side effects of Komboglyze include:
Maltese: Effetti sekondarji oħra ta' Komboglyze jinkludu:
English: • decreased vitamin B12 levels
Maltese: • tnaqqis fil-livelli ta' vitamina
English: Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Maltese: Daqs ta' pakketti ta' 14, 28, 56 u 60 pilloli miksijin b'rita ġo folji mhux imtaqqbin.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Maltese: Saxagliptin huwa inibitur DPP4 kompetittiv, riversibbli, selettiv, potenti ħafna (Ki: 1.3 nM).
English: EU/1/11/731/007 28 film-coated tablets EU/1/11/731/008 56 film-coated tablets EU/1/11/731/009 60 film-coated tablets EU/1/11/731/010 112 (2 packs of 56) film-coated tablets EU/1/11/731/011 196 (7 packs of 28) film-coated tablets EU/1/11/731/012 60x1 film-coated tablets EU/1/11/731/014 14 film-coated tablets
Maltese: EU/1/11/731/007 28 pillola miksija b'rita EU/1/11/731/008 56 pillola miksija b'rita EU/1/11/731/009 60 pillola miksija b'rita EU/1/11/731/010 112-il pillola (2 pakketti ta' 56) pillola miksija b'rita EU/1/11/731/011 196 (7 packs of 28) pillola miksija b'rita EU/1/11/731/012 60x1 pillola miksija b'rita EU/1/11/731/014 14-il pillola miksija b'rita
English: Alu/Alu blister.
Maltese: Folja Alu/alu.
English: Placebo-corrected mean change in HbA1c (%) (95% CI)
Maltese: Medja tal-HbA1c korretta skont ilplaċebo (%)(95% CI)
English: As initial combination with metformin: gastritis (common), arthralgia
Maltese: Bħala taħlita mill-bidu ma'metformin: gastrite (komuni), artralġja
English: EU/1/11/731/001 28 film-coated tablets EU/1/11/731/002 56 film-coated tablets EU/1/11/731/003 60 film-coated tablets EU/1/11/731/004 112 (2 packs of 56) film-coated tablets EU/1/11/731/005 196 (7 packs of 28) film-coated tablets EU/1/11/731/006 60x1 film-coated tablets EU/1/11/731/013 14 film-coated tablets
Maltese: EU/1/11/731/001 28 pillola miksijin b'rita EU/1/11/731/002 56 pillola miksijin b'rita EU/1/11/731/003 60 pillola miksijin b'rita EU/1/11/731/004 112-il (2 pakketti ta` 56) pillola miksijin b'rita EU/1/11/731/005 196 (7 pakketti ta' 28) pillola miksijin b'rita EU/1/11/731/006 60x1 pillola miksijin b'rita EU/1/11/731/013 14-il pillola miksijin b'rita
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 il-farmakikinetika ta' metformin, glibenclamide, pioglitazone, digoxin, simvastatin, il-komponenti attivi ta' kontraċettivi orali kombinati (ethinyl estradiol and norgestimate), diltiazem jew ketoconazole.
English: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: - tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe komplikazzjoni relatata maddijabete fil-grupp ta' metformin (29.8 każ/1,00 sena-pazjent) kontra dieta waħidha (43.3 każ/1,000 sena pazjent), p=0.0023, u kontra il-gruppi kombinati b'sulphonylurea u monoterapija b'insulina (40.1 każ/1,000 sena-pazjent), p=0.0034; - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mewt relatata mad-dijabete: metformin 7.5 każ/1,000 sena-pazjent, dieta waħidha 12.7 każ/1,000 sena pazjent, p=0.017; - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mewt relatata mad-dijabete: metformin 13.5 każ/1,000 sena-pazjent kontra dieta waħidha 20.6 każ/1,000 senapazjent, (p=0.011), u kontra l-gruppi kombinati ma' sulphonylurea u monoterapija b'insulina 18.9 każ/1,000 sena pazjent (p=0.021); - tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11il każ/1,000 sena-pazjent, dieta waħidha 18-il każ/1,000 sena-pazjent, (p=0.01).
English: Angioedema (see sections 4.3 and 4.4)
Maltese: Anġjoedema (ara sezzjonijiet 4.3 u 4.4)
English: Joint pain, which may be severe, has been reported in postmarketing reports for DPP4 inhibitors (see section 4.8).
Maltese: Uġigħ fil-ġogi, li jista' jkun sever, ġie rrapportat fir-rapporti ta' wara t-tqegħid fis-suq għallinibituri ta' DPP4 (ara sezzjoni 4.8).
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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-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), jew rari ħafna (< 1/10,000), mhux magħruf (ma jistax jiġi stabbilit mid-dejta disponibbli).
English: Table 2 Frequency of adverse reactions by system organ class
Maltese: Tabella 2 Frekwenza tar-reazzjonijiet avversi skond is-sistema ta' klassifikazzjoni talorgani
English: • muscle pain (myalgia)
Maltese: • ugigħ fil-muskoli (mijalġja)
English: Saxagliptin (n=186) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=175).
Maltese: Saxagliptin (n=186) għamel titjib sinifikanti fl-HbA1c, FPG, u PPG meta mqabbel mal-plaċebo (n=175).
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimula s-sintesi tal-glycogen intraċellulari billi jaħdem fuq glycogen synthase.
English: A lower proportion of patients in the saxagliptin group (44.7%) compared to the glimepiride group (54.7%) achieved an HbA1c target of 7.0%.
Maltese: Proporzjon iżgħar ta' pazjenti fil-grupp saxagliptin (44.7%) meta mqabbel mal-grupp glimepiride (54.7%) laħaq mira ta' HbA1c ta' 7.0%.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Maltese: Saxagliptin ma kienx ġenotossiku fil-medda ta' studji konvenzjonali in vitro u in vivo.
English: 2 (see sections 4.3 and 4.4)
Maltese: 2 (ara sezzjonijiet 4.3 u 4.4)
English: Rash is also noted as an adverse event (AE) for saxagliptin (see section 4.8).
Maltese: Raxx huwa każ avvers (AE) innutat ukoll għal saxagliptin (ara sezzjoni 4.8).
English: Frequency of adverse reactions
Maltese: Frekwenza tar-reazzjonijiet avversi
English: Komboglyze 2.5 mg/850 mg film-coated tablets EU/1/11/731/001
Maltese: Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita EU/1/11/731/001
English: Multipack: 112 (2 packs of 56) film-coated tablets Multipack: 196 (7 packs of 28) film-coated tablets 60x1 film-coated tablets
Maltese: Pakketti multipli: 112-il (2 pakketti ta' 56) pillola miksija b'rita Pakketti multipli: 196 (7 pakketti ta' 28) pillola miksija b'rita 60x1 pillola miksija b'rita
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Maltese: Pazjenti anzjani (65-80 sena) kellhom madwar 60% AUC ta' saxagliptin ogħla minn pazjenti iżgħar (18-40 sena).
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 15 July 2016
Maltese: Data tal-aħħar tiġdid: 15 ta' Lulju 2016
English: No combination toxicity was observed at AUC exposures 68 and 1.5 times the RHDs for saxagliptin and metformin, respectively.
Maltese: Ma dehritx tossiċità bittaħlita b'esponiment ta' AUC ta' 68 u 1.5-il darba l-RHDs għal saxagliptin u metformin, rispettivament.