FrancophonIA/ELRC3.0 huggingface dataset:
English: In a Phase 1 clinical pharmacology study in patients with type 2 diabetes and mild, moderate, or severe renal impairment (as determined by eGFR), following a single-dose administration of 15 mg ertugliflozin, the mean increases in AUC of ertugliflozin were ≤ 1.7-fold, compared to subjects with normal renal function.
Maltese: Fi studju farmakoloġiku kliniku ta' Fażi 1 f'pazjenti b'dijabete tat-tip 2 u indeboliment ħafif, moderat jew sever tal-kliewi (skont kif iddeterminat mill-eGFR), wara għoti ta' doża waħda ta' 15-il mg ertugliflozin, il-medja taż-żieda fl-AUC ta' ertugliflozin kienet ≤ 1.7 drabi aktar meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: Moderate renal impairment
Maltese: Indeboliment moderat tal-kliewi
English: Factorial study with ertugliflozin and sitagliptin as add-on combination therapy with metformin A total of 1,233 patients with type 2 diabetes participated in a randomised, double-blind, multi-centre, 26-week, active-controlled study to evaluate the efficacy and safety of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg compared to the individual components.
Maltese: Studju dwar fatturi b'ertugliflozin u sitagliptin bħala terapiji miżjuda flimkien ma' metformin Total ta' 1,233 pazjent b'dijabete tat-tip 2 ipparteċipaw fi studju ta' 26 ġimgħa, arbitrarju, b'ħafna ċentri, ikkontrollat b'mod attiv, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin 5 mg jew 15-il mg flimkien ma' sitagliptin 100 mg imqabbel mal-komponenti individwali.
English: Dysuria, Blood creatinine increased/Glomerular filtration rate decreased
Maltese: Żieda ta' kreatinina fid-demm/Tnaqqis fir-rata ta' filtrazzjoni mill-glomeruli u avvenimenti marbuta mal-kliewi
English: Steglatro 15 mg
Maltese: Steglatro 15-il mg
English: These are the signs of diabetic ketoacidosis (see also section “Warnings and precautions”):
Maltese: Dawn huma s-sinjali ta' ketoaċidożi tad-dijabete (ara wkoll is-sezzjoni “Twissijiet u prekawzjonijiet”):
English: Table 6: Results at Week 26 from an add-on study of Steglatro in combination with metformin and sitagliptin*
Maltese: Tabella 6: Riżultati f'Ġimgħa 26 minn studju ta' Steglatro miżjud flimkien ma' metformin u sitagliptin*
English: Before initiating ertugliflozin, consider factors in the patient history that may increase the risk for amputation.
Maltese: Qabel ma tibda ertugliflozin, qis fatturi fl-istorja tal-pazjent li jistgħu jżidu r-riskju ta' amputazzjoni.
English: Alternative methods should be used to monitor glycaemic control.
Maltese: Għandhom jinużaw metodi alternattivi biex jiġi mmonitorjat il-kontroll gliċemiku.
English: Steglatro should be discontinued when eGFR is persistently less than 45 ml/min/1.73 m 2 or CrCl is persistently less than 45 ml/min.
Maltese: Steglatro għandu jitwaqqaf meta l-eGFR tkun b'mod persistenti inqas minn 45 ml/min/1.73 m2 jew il-CrCl tkun b'mod persistenti inqas minn 45 ml/min.
English: CARTON FOR STEGLATRO 5 mg
Maltese: KARTUNA TA' STEGLATRO 5 mg
English: The proportion of subjects having any occurrence of BUN values ≥ 50% increase and value >ULN was numerically higher in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group
Maltese: Il-proporzjon ta' individwi li kellhom kwalunkwe okkorrenza ta' żieda ≥ 50% fil-valuri BUN u valuri >ULN kienu numerikament ogħla fil-grupp ta' ertugliflozin 5 mg u ogħla fil-grupp ta' 15-il mg (7.9% u 9.8%, rispettivament) relattiv għall-grupp tal-plaċebo (5.1%).
English: • Steglatro lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
Maltese: • Steglatro jbaxxi l-livelli taz-zokkor fid-demm f'pazjenti adulti (li għandhom 18-il sena u aktar)
English: Balanitis candida and other male genital mycotic infections*
Maltese: Kandida balanite u infezzjonijiet mikotiċi oħra talġenitali fl-irġiel*,†
English: At a maternally toxic dose in rats (250 mg/kg/day), lower foetal viability and a higher incidence of a visceral malformation were observed at maternal exposure that was 510 times the maximum clinical dose of 15 mg/day.
Maltese: B'doża tossika għall-omm fil-firien (250 mg/kg/jum), kienu osservati vijabilità inqas tal-fetu u inċidenza ogħla ta' formazzjoni ħażina fil-vixxri b'esponiment tal-omm li kien 510 drabi akbar mill-ogħla doża klinika ta'
English: EU/1/18/1267/013
Maltese: EU/1/18/1267/006 EU/1/18/1267/013
English: comparisons).
Maltese: 10 persuni)
English: Hypoglycaemia with concomitant use with insulin and insulin secretagogues Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue, which are known to cause hypoglycaemia (see section 4.8).
Maltese: Ipogliċemija b'użu flimkien mal-insulina u ma' sustanzi li jikkawżaw it-tnixxija tal-insulina Ertugliflozin jista' jżid ir-riskju ta' ipogliċemija meta jintuża flimkien mal-insulina u/jew ma' sustanza li tikkawża t-tnixxija tal-insulina, li huma magħrufa li jikkawżaw l-ipogliċemija (ara sezzjoni 4.8).
English: Blood creatinine increased/Glomerular filtration rate decreased and renal-related events Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin were generally transient during continuous treatment.
Maltese: Iż-żidiet fil-medja tal-kreatinina u t-tnaqqis fil-medja tal-eGFR tal-bidu f'pazjenti ttrattati b'ertugliflozin ġeneralment kienu temporanji waqt trattament kontinwu.
English: How to store Steglatro 6.
Maltese: Kif taħżen Steglatro 6.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
Maltese: Ketoaċidożi tad-dijabete (rari, tista' taffettwa sa persuna 1 minn kull 1,000)
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi tad-dijabete għandu jitqies f'każ ta' sintomi mhux speċifiċi bħal nawsja, rimettar, anoreksja, uġigħ fl-addome, għatx eċċessiv, diffikultà fit-teħid tan-nifs, konfużjoni, għeja jew ngħas mhux tas-soltu.
English: Ertugliflozin works by blocking the SGLT2 protein in your kidneys.
Maltese: Ertugliflozin jaħdem billi jimblokka l-proteina SGLT2 fil-kliewi tiegħek.
English: No effects on fertility were observed at 250 mg/kg/day (approximately 386 times human unbound exposure at the MRHD of 15 mg/day based on AUC
Maltese: Ma ġew osservati l-ebda effetti fuq il-fertilità b'250 mg/kg/jum (madwar 386 darba aktar mill-esponiment għall-mediċina mhux marbuta fil-bniedem b'MRHD ta' 15-il mg/jum abbażi ta' tqabbil tal-AUC).
English: Steglatro 15 mg film-coated tablets Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Maltese: o Kull pillola miksija b'rita ta' Steglatro 15-il mg fiha 15-il mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid).
English: Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Maltese: Steglatro huwa indikat fl-adulti li għandhom 18-il sena u aktar b'dijabete mellitus tat-tip 2 bħala żieda mad-dieta u mal-eżerċizzju biex itejjeb il-kontroll gliċemiku:
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw aktar minn persuna 1 minn kull 100)
English: • vaginal yeast infection (thrush)
Maltese: • infezzjoni bil-ħmira fil-vaġina (traxx)
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with ertugliflozin (see sections 4.2, 4.4, and 4.8).
Maltese: reazzjonijiet avversi marbuta ma' tnaqqis fil-volum, bħal ma huwa sturdament meta wieħed iqum bilwieqfa (ara sezzjonijiet 4.2, 4.4, u 4.8).
English: Steglatro 5 mg film-coated tablets Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Maltese: o Kull pillola miksija b'rita ta' Steglatro 5 mg fiha 5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid).
English: CARTON FOR STEGLATRO 15 mg
Maltese: KARTUNA TA' STEGLATRO 15-il mg
English: Each film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid).
Maltese: Kull pillola miksija b'rita fiha 15-il mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid).
English: Based on results from animal studies, ertugliflozin may affect renal development and maturation (see section 5.3).
Maltese: Ma kienu osservati l-ebda effetti fuq il-fertilità fi studji fl-annimali (ara sezzjoni 5.3).
English: The no-observed-effect level (NOEL) for neoplasia was 5 mg/kg/day (approximately 16 times human unbound exposure at the MRHD of 15 mg/day).
Maltese: Il-livell fejn ma ġie osservat l-ebda effett (NOEL, no-observed-effect level) għal neoplasja kien 5 mg/kg/jum (madwar 16-il darba aktar mill-esponiment għall-mediċina mhux marbuta fil-bniedem b'MRHD ta'
English: p 0.001 compared to placebo.
Maltese: A10BK04.
English: Patients should be alerted to the risk of hypoglycaemia when Steglatro is used in combination with insulin or an insulin secretagogue and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4, and 4.8).
Maltese: Għalhekk, tista' tkun meħtieġa doża aktar baxxa tal insulina jew tas-sustanza li tikkawża t-tnixxija tal-insulina biex jitnaqqas ir-riskju tal-ipogliċemijameta jintużaw flimkien ma' ertugliflozin (ara sezzjonijiet 4.2, 4.4, u 4.8).
English: Table 3: Results at Week 26 from a placebo-controlled study for Steglatro used in combination with metformin*
Maltese: Tabella 3: Riżultati f'Ġimgħa 26 minn studju ikkontrollat bil-plaċebo ta' Steglatro użat flimkien ma' metformin*
English: In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving ertugliflozin.
Maltese: F'każ ta' kondizzjonijiet li jistgħu jwasslu għal telf ta' fluwidi (eż., mard gastrointestinali), huwa rakkomandat monitoraġġ b'attenzjoni tal-istat tal-volum (eż., eżami fiżiku, kejl tal-pressjoni, testijiet tal-laboratorju inkluż l-ematokrit) u tal-elettroliti għall-pazjenti li jkunu qed jirċievu ertugliflozin.
English: How Steglatro works
Maltese: Steglatro.
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin and sitagliptin therapy (see Table 6).
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jirċievu ertugliflozin 5 mg, ertugliflozin 15-il mg, jew plaċebo darba kuljum flimkien mat-tkomplija tat-terapija fl-isfond b'metformin u sitagliptin (ara Tabella 6).
English: Ertugliflozin has also been studied in combination with current diabetes treatments, including insulin and a sulphonylurea, in patients with type 2 diabetes with moderate renal impairment.
Maltese: Ertugliflozin ġie studjat ukoll flimkien ma' trattamenti attwali tad-dijabete, inklużi l-insulina u wieħed mis-sulphonylurea, f'pazjenti b'dijabete tat-tip 2 b'indeboliment moderat tal-kliewi.
English: Steglatro should not be initiated in patients with an eGFR below 60 ml/min/1.73 m 2 or CrCl below 60 ml/min.
Maltese: Steglatro m'għandux jinbeda f'pazjenti b'eGFR inqas minn 60 ml/min/1.73 m2 jew CrCl inqas minn 60 ml/min.
English: Difference from Sitagliptin Steglatro 5 mg Steglatro 15 mg (LS mean
Maltese: Sitagliptin Steglatro 5 mg Steglatro 15-il mg
English: Volume depletion*
Maltese: Fournier)*
English: Glimepiride was initiated at 1 mg/day and titrated up to a maximum dose of 6 or 8 mg/day (depending on maximum approved dose in each country) or a maximum tolerated dose or down-titrated to avoid or manage hypoglycaemia.
Maltese: Glimepiride inbeda bid-doża ta' 1 mg/jum u żdied bil-mod il-mod sa doża massima ta' 6 jew 8 mg/jum (skont id-doża massima approvata ta' kull pajjiż) jew sad-doża massima ttollerata jew tnaqqas bil-mod il-mod biex tiġi evitata jew immaniġġjata l-ipogliċemija.
English: - More frequently in patients with an eGFR below 60 ml/min/1.73 m2 or a CrCl below 60 ml/min.
Maltese: - Aktar frekwenti f'pazjenti b'eGFR inqas minn 60 ml/min/1.73 m2 jew CrCl inqas minn
English: No dose adjustment of ertugliflozin is recommended based on age.
Maltese: It-tneħħija ta' ertugliflozin permezz tal-emodijalisi ma ġietx studjata.
English: These patients, who were not receiving any background anti-hyperglycaemic treatment, were randomised to ertugliflozin 5 mg or ertugliflozin 15 mg in combination with sitagliptin (100 mg) or to placebo once daily (see Table 7).
Maltese: Dawn il-pazjenti, li ma kienu qed jirċievu l-ebda trattament antiipergliċemiku fl-isfond, intagħżlu b'mod arbitrarju biex jirċievu ertugliflozin 5 mg jew ertugliflozin 15-il mg flimkien ma' sitagliptin (100 mg) jew plaċebo darba kuljum (ara Tabella 7).
English: In the monotherapy study conducted on a background of diet and exercise in patients with baseline HbA1c from 7-10.5%, the subgroup of patients in the study with a baseline HbA1c ≥ 8% had placebo-corrected reductions in HbA1c of 1.11% and 1.52% with ertugliflozin 5 or 15 mg, respectively.
Maltese: 5% fillinja bażi, is-sottogrupp ta' pazjenti fl-istudju b'HbA1c ≥ 8% fil-linja bażi kellhom tnaqqis fl-HbA1c ikkoreġut mill-plaċebo ta' 1.11% u 1.52% b'ertugliflozin 5 mg jew 15-il mg, rispettivament.
English: • sweating
Maltese: FIS-SUQ
English: In males, discontinuations due to genital mycotic infections occurred in 0.2% and 0% of patients treated with ertugliflozin and placebo, respectively.
Maltese: Fl-irġiel, it-twaqqif minħabba infezzjonijiet mikotiċi fil-ġenitali seħħ f'0.2% u 0% tal-pazjenti trattati b'ertugliflozin u bilplaċebo, rispettivament.
English: EU/1/18/1267/011
Maltese: EU/1/18/1267/011 EU/1/18/1267/012 EU/1/18/1267/014
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors.
Maltese: Interferenza mal-analiżi ta' 1,5-anhydroglucitol (1,5 AG)
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin therapy (see Table 3).
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jingħataw ertugliflozin 5 mg, ertugliflozin 15-il mg, jew plaċebo darba kuljum flimkien mat-tkomplija tat-terapija fl-isfond b'metformin (ara Tabella 3).
English: These patients, who were not receiving any background antihyperglycaemic treatment, were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily (see Table 2).
Maltese: Dawn il-pazjenti, li ma kienu qed jirċievu l-ebda trattament antiipergliċemiku fl-isfond, intagħżlu b'mod arbitrarju biex jingħataw ertugliflozin 5 mg, ertugliflozin 15-il mg, jew plaċebo darba kuljum (ara Tabella 2).
English: Ertugliflozin did not show any toxicity in healthy subjects at single oral doses up to 300 mg and multiple doses up to 100 mg daily for 2 weeks.
Maltese: Ertugliflozin ma wera l-ebda tossiċità f'individwi f'saħħithom b'dożi waħdiet mill-ħalq sa 300 mg u ħafna dożi sa 100 mg kuljum għal ġimagħtejn.
English: These patients, who were receiving metformin monotherapy (≥ 1,500 mg/day), were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or glimepiride administered once daily in addition to continuation of background metformin therapy.
Maltese: F'pazjenti li jkunu qed jittolleraw ertugliflozin 5 mg darba kuljum, id-doża tista' tiżdied għal 15-il mg darba kuljum jekk ikun meħtieġ kontroll gliċemiku addizzjonali.
English: Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
Maltese: Tinkludi: pollakijurja, urġenza biex tagħmel l-awrina, polijurja, żieda fl-ammont tal-awrina li tgħaddi, u awrina bil-lejl. §
English: Steglatro 5 mg film-coated tablets Steglatro 15 mg film-coated tablets ertugliflozin
Maltese: Steglatro 5 mg pilloli miksija b'rita Steglatro 15-il mg pilloli miksija b'rita ertugliflozin
English: L-2540 Luxembourg
Maltese: L-2540
English: 7 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
Maltese: 7 pilloli 14-il pillola 28 pillola 49 pillola 56 pillola 98 pillola
English: N-dealkylation of the pyrrolidine nitrogen.
Maltese: N-dealkylation ta' pyrrolidine nitrogen.
English: 26-28, rue Edward Steichen L-2540 Luxembourg Tel: +352 26 37 58 78
Maltese: 26-28, rue Edward Steichen L-2540 Lussemburgu Tel: +352 26 37 58 78
English: Date of latest renewal: 24 September 2009
Maltese: Data ta' l-aħħar tiġdid: 24 Settembru 2009
English: Differences from placebo1
Maltese: Differenzi mill-plaċebo1
English: Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Maltese: Darifenacin huwa antagonist selettiv muskariniku tar-riċettur M3 (M3 SRA) in vitro.
English: Calcium hydrogen phosphate, anhydrous
Maltese: Calcium hydrogen phosphate, anhydrous Hypromellose
English: Visual disturbance, including vision blurred
Maltese: Disturbi fil-vista, inkluż vista mċajpra
English: The active substance is darifenacin.
Maltese: Is-sustanza attiva hi darifenacin.
English: PHARMACEUTICAL FORM AND CONTENTS 140 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 140 pillola
English: (median)
Maltese: (medjan)
English: The steady-state volume of distribution (Vss) is estimated to be 163 litres.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vss) huwa stmat li jkun 163 litru.
English: Dyspnoea, cough, rhinitis
Maltese: Dispneja, sogħla, rinite
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 October 2004
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 22 Ottubru 2004
English: Emselex is contraindicated in patients with:
Maltese: Emselex huwa kontra-indikat f'pazjenti:
English: 1 Hodges Lehmann estimate: median difference from placebo in change from baseline 2 Stratified Wilcoxon test for difference from placebo.
Maltese: 1 Stima Hodges Lehmann: differenza medjana mill-plaċebo fil-bidla mill-linja bażi 2 Test Wilcoxon stratifikat għad-differenza mill-plaċebo.
English: • antipsychotic medicines (e.g. thioridazine),
Maltese: • mediċini antipsikotiċi (eż. thioridazine),
English: Week 12 (median)
Maltese: Ġimgħa 12 (medjan)
English: Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Maltese: Hekk kif inhu mistenni mill-profil farmakoloġiku tiegħu, ir-reazzjonijiet avversi li kienu rrapurtati laktar kienu jinkludu ħalq xott (20.2% u 35% għad-dożi ta' 7.5 mg u 15 mg rispettivament, 18.7% wara li d-doża tkun żdiedet bil-mod, b'mod flessibbli, u 8% - 9% għall-plaċebo) u stitikezza (14.8% u 21% għad-doża ta' 7.5 mg u 15 mg rispettivament, 20.9% wara li d-doża tkun żdiedet bil-mod, b'mod flessibbli, u 5.4% - 7.9% għall-plaċebo.
English: INFORMATION IN BRAILLE Emselex 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Emselex 15 mg
English: • certain antibiotics (e.g. erythromycin, clarithromycin and rifampicin),
Maltese: • ċerti antibijotiċi (eż. erythromycin, clarithromycin u rifampicin),
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Maltese: Is- sustanzi l-oħra huma calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) u yellow iron oxide (E172).
English: Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Maltese: Mhux komuni (jistgħu jeffettwaw sa persuna waħda f'kull 100 ruħ) Għeja, korriment aċċidentali, nefħa tal-wiċċ, pressjoni għolja, dijarea, gass fl-istonku, infjammazzjoni tal-membrana mukuża tal-ħalq, żieda fl-enzimi tal-fwied, nefħa, sturdament, nuqqas ta' rqad, telqa, ħsibijiet anormali, iqattarlek imnieħrek (rinite), sogħla, qtugħ ta' nifs, ġilda xotta, ħakk, raxx, għaraq, disturbi tal-vista, inkluża vista mċajpra, disturbi fit-togħma, disturbi fis-sistema tal-awrina jew infezzjoni, impotenza, tnixxija jew ħakk tal-vaġina, uġigħ fil-bużżieqa tal-awrina, ma tkunx tista' tbattal il-bużżieqa tal-awrina.
English: INFORMATION IN BRAILLE Emselex 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Emselex 7.5 mg
English: Merus Labs Netherlands B.V., Alexander Battalaan 37
Maltese: Merus Labs Netherlands B.V. Alexander Battalaan 37 6221 CB Maastricht L-Olanda
English: Darifenacin is a lipophilic base and is 98% bound to plasma proteins (primarily to alpha-1-acidglycoprotein).
Maltese: Darifenacin huwa bażi lipofiliku u huwa 98% marbut mal-proteini tal-plażma (fil-parti l-kbira malalpha-1-acid-glycoprotein).
English: • other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate).
Maltese: • mediċini antimuskariniċi oħrajn (eż. tolterodine, oxybutynin u flavoxate).
English: Aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning, and procedural complications Uncommon
Maltese: Aspartate aminotransferase miżjud, alanine aminotransferase miżjud Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Mhux komuni
English: • antifungal medicines (e.g. ketoconazole and itraconazole),
Maltese: • mediċini kontra l-mard tal-moffa (eż. ketoconazole u itraconazole),
English: P value2
Maltese: Valur P2
English: The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) and talc.
Maltese: Is-sustanzi l-oħra huma calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) u talc.
English: Oedema peripheral, asthenia, face oedema, oedema
Maltese: Edima periferali, astenja, edima fil-wiċċ, edima
English: Darifenacin pharmacokinetics were investigated in subjects with mild (Child Pugh A) or moderate (Child Pugh B) impairment of hepatic function given darifenacin 15 mg once daily to steady state.
Maltese: Il-farmakokinetika ta' darifenacin kienet investigata f'individwi li kellhom indeboliment ħafif (ChildPugh A) jew moderat (Child-Pugh B) tal-fwied li ngħataw 15 mg darifenacin darba kuljum għal stat fiss.
English: The effect of treatment with 15 mg and 75 mg of darifenacin on QT/QTc interval was evaluated in a study in 179 healthy adults (44% male: 56% females) aged 18 to 65 for 6 days (to steady state).
Maltese: L-effett tal-kura b'15 mg u 75 mg ta' darifenacin fuq l-intervall QT/QTc kien evalwat fi studju b'179 adult b'saħħithom (44% irġiel:56% nisa) f'etajiet ta' 18 sa 65 sena għal 6 ijiem (għal stat fiss).
English: The adverse reactions are ranked under heading of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hi mfissra kif ġej: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma jistax jiġi stmat mit-tagħrif attwali).