FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people.
Maltese: Il-frekwenza ta' reazzjoni allerġika severa (reazzjoni anafilattika) u nefħa fil-wiċċ hi kkunsidrata li hi komuni u tista' taffettwa sa persuna 1 minn kull 10.
English: - The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: ADRs were all mild to moderate in severity.
Maltese: L-ADRs kienu kollha ta' intensità minn ħafifa sa moderata.
English: Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus.
Maltese: Laronidase ppurifikat hu glikoproteina b'piż molekulari ta' madwar 83 kDa.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyse the accumulated substrate and to prevent further accumulation.
Maltese: Ir-raġuni fundamentali tat-terapija tas-sostituzzjoni ta' l-enzimi hi biex treġġa' lura għan-normal livell ta' attività enzimatika li jkun suffiċjenti biex jidrolizza s-substrat akkumulat, u biex ma jħallix li ssir akkumulazzjoni addizzjonali.
English: Very common symptoms (may affect more than 1 in 10 people) which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site.
Maltese: Sintomi komuni ħafna (jistgħu jaffettwaw iktar minn persuna 1 minn kull 10) li ma kinux serji, jinkludu uġigħ ta' ras, tqalligħ, uġigħ addominali, raxx, mard fil-ġogi, uġigħ fil-ġogi, uġigħ fid-dahar, uġigħ fid-dirgħajn jew fir-riġlejn, fwawar, deni, tertir, żieda fir-rata tat-taħbit tal-qalb, żieda filpressjoni tad-demm, u reazzjoni fis-sit tal-infużjoni.
English: Body temperature increased, oxygen saturation decreased
Maltese: Temperatura tal-ġisem li tiżdied tnaqqis fis-saturazzjoni ta' l-ossiġnu
English: median 38.5 0.066 -2.0 - 79.0
Maltese: medja medjan 38.5 0.066
English: An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Maltese: Reazzjoni marbuta ma' l-infużjoni hi kwalunkwe effett sekondarju li jseħħ matul l-infużjoni jew sat-tmiem tal-jum ta' l-infużjoni (ara sezzjoni 4 “Effetti Sekondarji Possibbli”).
English: The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks.
Maltese: Il-pazjenti kienu skedati biex jirċievu infużjonijiet ta' Aldurazyme 100 U/kg kull ġimgħa għal tul ta' żmien totali ta' 52 ġimgħa.
English: Talk to your doctor before using Aldurazyme.
Maltese: Mediċini oħra u Aldurazyme
English: The infusion can be restarted with a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the reaction occurred.
Maltese: L-infużjoni tista' terġa' tinbeda bi tnaqqis fir-rata ta' l-infużjoni għal 1/2 - 1/4 tar-rata li fiha seħħet ir-reazzjoni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
Maltese: KAXXA TAL-KARTUN TA' BARRA (1 KUNJETT, 10
English: Side effects were mainly seen while patients were being given the medicine or shortly after (infusionassociated reactions).
Maltese: L-effetti sekondarji kienu osservati primarjament waqt li l-pazjenti kienu qed jingħataw il-mediċina jew ftit wara (reazzjonijiet marbuta ma' l-infużjoni).
English: Batch
Maltese: KUNJETT
English: Upon study completion, all patients showed reductions in liver size and 50% (9/18) had normal liver size.
Maltese: Meta l-istudju tlesta, il-pazjenti kollha wrew tnaqqis fid-daqs tal-fwied u 50% (9/18) minnhom kellhom daqs normali tal-fwied.
English: It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Maltese: Hu rakkomandat li s-soluzzjoni dilwita ta' Aldurazyme tingħata lill-pazjenti permezz ta' sett ta' l-infużjoni mgħammar b'filtru in-line ta' 0.2 µm.
English: No information is available on the effects of Aldurazyme on fertility.
Maltese: L-ebda informazzjoni mhi disponibbli dwar l-effetti ta' Aldurazyme fuq il-fertilità.
English: Tél: 0 800 222 555
Maltese: France sanofi-aventis France Tél: 0 800 222 555
English: Phase 3, 26 weeks of treatment compared to placebo p value Confidence interval
Maltese: Fażi 3, 26 ġimgħa ta' kura meta mqabbla mal-plaċebo valur p
English: • muscle pain
Maltese: • uġigħ tal-muskoli
English: The younger patients with the severe phenotype (< 2.5 years) and all 4 patients with the intermediate phenotype exhibited a normal rate of mental development, whereas the older patients with a severe phenotype made limited or no gains in cognition.
Maltese: Il-pazjenti aktar żgħar fl-età bil-fenotip sever (< 2.5 snin) u l-4 pazjenti kollha bil-fenotip intermedju, urew rata normali ta' żvilupp mentali, filwaqt li pazjenti akbar fl-età b'fenotip sever kellhom titjib limitat jew l-ebda progress fil-konjizzjoni.
English: In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks.
Maltese: F'dan l-istudju open label ta' 26 ġimgħa, 33 pazjenti MPS I irċivew minn 1 sa 4 korsijiet ta' doża ta' Aldurazyme: 100
English: If not used immediately, in-use storage should not be longer than 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-ħażna tal-prodott waqt l-użu m'għandhiex tkun ta' iktar minn 24 siegħa f'temperatura ta' 2°C - 8°C, dejjem jekk id-dilwizzjoni tkun seħħet taħt kundizzjonijiet asettiċi kkontrollati u validati.
English: Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4).
Maltese: Flimkien ma' dan, ftit pazjenti li kellhom storja medika fil-passat ta' disturb fin-naħa ta' fuq talpassaġġ tan-nifs u disurb pulmonari marbut ma' MPS I, kellhom reazzjonijiet severi li kienu jinkludu bronkospażmu, waqfien respiratorju, u edema tal-wiċċ (ara sezzjoni 4.4).
English: Dosage
Maltese: MedDRA
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Maltese: U/ml konċentrat għal soluzzjoni għall-infużjoni laronidase
English: The safety and efficacy of Aldurazyme was assessed in a randomised, double-blind, placebo controlled, Phase 3 Study of 45 patients, ranging in age from 6 to 43 years.
Maltese: Is-siġurtà u l-effikaċja ta' Aldurazyme kienu evalwati fi Studju ta' Fażi 3 li kien randomised, double-blind u kkontrollat bil-plaċebo li sar fuq 45 pazjent li kellhom minn 6 sa 43 sena.
English: ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below.
Maltese: 2 f'total ta' 20 pazjent li kellhom inqas minn 5 snin u li kienu primarjamet tal-fenotipsever, u li kienu kkurati sa perijodu ta' 12-il xahar, huma elenkati hawn taħt.
English: • paleness
Maltese: • sturdament
English: Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Iddeċiedi l-volum totali ta' infużjoni bbażat fuq il-piż tal-pazjent individwali, jew 100 ml (jekk il-piż tal-ġisem hu ta' 20 kg jew inqas) jew 250 ml (jekk il-piż tal-ġisem hu ta' iktar minn 20 kg) ta' soluzzjoni ġol-vini ta' 0.9% ta' sodium chloride.
English: Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Maltese: Iġbed u armi volum tas-soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) ta' sodium chloride millborża ta' l-infużjoni li jkun daqs il-volum totali ta' Aldurazyme li jrid jiġi miżjud.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction.
Maltese: Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi waħidhom, effett tossiku minn dożi ripetuti u l-effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bnedmin.
English: People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Maltese: Nies li jkollhom il-marda MPS I, jew ikollhom livell baxx jew l-ebda livell ta' enzima msejħa α-Liduronidase, li tkisser sustanzi speċifiċi (glycosaminoglycans) fil-ġisem.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred.
Maltese: F'każ ta' IAR ħafifa jew moderata, il-kura bl-antistamini u paracetamol/ibuprofen u/jew it-tnaqqis tar-rata ta' l-infużjoni bin-nofs tar-rata li fiha seħħet ir-reazzjoni, għandhom ikunu kkunsidrati.
English: Aldurazyme should not be mixed with other medicinal products in the same infusion.
Maltese: Alderazyme m'għandux jitħallat ma' prodotti mediċinali oħra fl-istess infużjoni.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Maltese: Il-konċentrat għal soluzzjoni għall-infużjoni għandu jkun dilwit b'soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) ta' sodium chloride billi tuża t-teknika asettika.
English: One study mainly assessed the safety and pharmacokinetics of Aldurazyme in patients less than 5 years old, but some efficacy measurements were included as well.
Maltese: Studju wieħed evalwa primarjament is-sigurtà u l-farmakokinetika ta' Aldurazyme f'pazjenti li kellhom inqas minn 5 snin, iżda xi kejl ta' l-effikaċja kien inkluż ukoll.
English: The potential risk for humans is unknown.
Maltese: Il-potenzjal ġenotossiku u karċinoġeniku mhuwiex mistenni.
English: Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C).
Maltese: Oħroġ il-kunjetti li teħtieġ mill-friġg madwar 20 minuta qabel sabiex tippermettilhom jilħqu t-temperatura tal-kamra (taħt 30˚C).
English: However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions.
Maltese: Madankollu, reazzjoni allerġika severa (reazzjoni anafilattika) ġiet osservata f'pazjenti matul jew sa 3 sigħat wara l-infużjonijiet b'Aldurazyme.
English: A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face.
Maltese: Ftit pazjenti li kellhom storja medika fil-passat ta' involviment tal-passaġġ ta' fuq tan-nifs u pulmonari marbut ma' MPS I, kellhom reazzjonijiet severi li jinkludu bronkospażmu (il-passaġġ tal-arja jidjieq), waqfien respiratorju, u nefħa fil-wiċċ.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of laronidase in a clinically significant way.
Maltese: Konsegwentement, l-indeboliment fil-funżjoni tal-fwied mhux mistenni li jaffettwa l-farmakokinetika ta' laronidase b'mod li hu klinikament sinifikanti.
English: mean 5.6median 3.0 0.009 0.9 - 8.6
Maltese: medja medjan 3.0 0.009
English: At 182 weeks
Maltese: Wara 182 ġimgħa
English: By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted.
Maltese: Sat-tmiem ta' l-istudju ta' Fażi 3 (jew fiż-żmien li l-pazjent ħareġ kmieni mill-istudju), 13/45 pazjent ma kellhom l-ebda antikorpi li setgħu jkunu osservati permezz ta' l-assaġġ radioimmunoprecipitation (RIP), li kienu jinkludu 3 pazjenti li qatt ma kellhom serokonverżjoni.
English: The type of IARs was similar to those seen in other clinical studies.
Maltese: It-tip ta' IARs kienu simili għal dawk li kienu osservati fi studji kliniċi oħrajn.
English: 1 The decrease in percent predicted FVC is not clinically significant over this timeframe, and absolute lung volumes continued to increase commensurate with changes in height in growing paediatric patients.
Maltese: 1 It-tnaqqis fil-perċentwali mbassar tal-FVC mhuwiex klinikament sinifikanti fuq dan il-perijodu, u lvolumi assoluti tal-pulmun komplew jiżdiedu fi proporzjon mat-tibdil fit-tul f'pazjenti pedjatriċi li kienu qed jikbru.
English: France sanofi-aventis France
Maltese: Ireland sanofi-aventis Ireland Ltd.
English: In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment.
Maltese: Fi studji kliniċi l-IARs normalment kienu kkontrollati bit-tnaqqis tar-rata ta' l-infużjoni u bil-kura talpazjent minn qabel bl-antistamini u/jew antipiretiċi (paracetamol jew ibuprofen), u dan għamilha possibbli li l-pazjent seta' jkompli jirċievi l-kura.
English: Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme.
Maltese: Għarraf lit-tabib tiegħek jekk qed tuża mediċini li fihom chloroquine jew procaine, minħabba riskju possibbli ta' tnaqqis ta' l-azzjoni ta' Aldurazyme.
English: Arthropathy, arthralgia, back pain, pain in extremity
Maltese: Artropatija, artralġja, uġigħ fid-dahar, uġigħ fl-estremitajiet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/253/001 1 Kunjett
English: With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Maltese: Meta Aldurazyme jingħata għall-ewwel darba jew meta jerġa' jibda jingħata wara interruzzjoni tal-kura, hu rakkomandat li l-pazjenti jingħataw mediċini ta' qabel il-kura (antistamini u/jew antipiretiċi) madwar 60 minuta qabel il-bidu ta' l-infużjoni, biex l-okkorrenza potenzjali ta' IARs tkun imminimizzata.
English: The expiry date refers to the last day of that month.
Maltese: In-numru ta' dawn ir-reazzjonijiet naqas aktar ma lpazjenti damu fuq Aldurazyme.
English: The third study was conducted to evaluate the pharmacodynamics and safety of different dose regimens of Aldurazyme.
Maltese: Ittielet studju sar biex jevalwa l-farmakodinamika u s-sigurtà ta' korsijiet ta' doża differenti ta' Aldurazyme.
English: The following information is intended for healthcare professionals only:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Pharmacotherapeutic group: Enzymes.
Maltese: Kategorija farmakoterapewtika:
English: 10 microgram ___ / ___ / ___ ___ / ___ / ___ 20 microgram ___ / ___ / ___ ___ / ___ / ___
Maltese: 10 mikrogrammi 20 mikrogramma ___ / ___ / ___ ___ / ___ / ___
English: Lixi n(%) Placebo n(%)
Maltese: Lixi n(%) Plaċebo n(%)
English: Figure 1: Forest plot: analyses of each individual cardiovascular event -- ITT population
Maltese: Figura 1: Forest plot: analiżi ta' kull avveniment kardjovaskulari individwali -- popolazzjoni ITT
English: Lixisenatide has a moderate level of binding (55%) to human proteins.
Maltese: Lixisenatide għandu livell moderat ta' rbit (55%) mal-proteini umani.
English: Lixisenatide is a peptide and is not metabolised by cytochrome P450.
Maltese: Lixisenatide hu peptide u mhux metabolizzat minn cytochrome P450.
English: Secondary composite endpoints primary + HF primary + HF + Revasc 661 (21.8%) 659 (21.7%) Individual components of composites CV death
Maltese: Punti ewlenin sekondarji komposti primarju + HF primarju + HF + Revasc 661 (21.8%) 659 (21.7%) Komponenti individwali tal-komposti mewta KV IM
English: Harzard Ratio with 95% CI
Maltese: Hazard Ratio b'95% CI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 01 Frar 2013
English: Lixisenatide is a selective GLP-1 receptor agonist.
Maltese: Lixisenatide huwa agonist selettiv tar-riċettur GLP-1.
English: Placebo (N= 286)
Maltese: Plaċebo (N= 286)
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Germany
Maltese: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Il-Ġermanja
English: Each dose contains 540 micrograms of metacresol.
Maltese: Kull doża fiha 540 mikrogramma ta' metacresol.
English: The rate of symptomatic hypoglycaemic events was lower with lixisenatide (36%) compared to insulin glulisine QD and TID (47% and 52%, respectively).
Maltese: Ir-rata ta' avvenimenti ta' ipogliċemija sintomatika kienet inqas b'lixisenatide (36%) meta mqabbla ma' insulin glulisine QD u TID (47% u 52%, rispettivament).
English: Lyxumia contains the active substance lixisenatide.
Maltese: Lyxumia fih is-sustanza attiva lixisenatide.
English: • Drowsiness (somnolence)
Maltese: • Ħedla (sonnolenza)
English: The AUC and Cmax of the active metabolite (ramiprilat) were not affected.
Maltese: L-AUC u Cmax tal-metabolit attiv (ramiprilat) ma ġewx affettwati.
English: Lixisenatide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP).
Maltese: L-azzjoni ta' lixisenatide hija medjata permezz ta' interazzjoni speċifika mar-receptors GLP-1 li twassal għal żieda fis-cyclic adenosine monophosphate intraċellulari (cAMP).
English: Pharmacotherapeutic group: Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ03
Maltese: Mediċini użati fid-dijabete, analogi ta' peptide-1 li jixbaħ lil glucagon (GLP-1), kodiċi ATC : A10BJ03
English: Pen Date of activation
Maltese: Data t'attivazzjoni
English: Populations not studied Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: Popolazzjonijiet li ma ġewx studjati Lixisenatide ma ġiex studjat flimkien ma' inibituri ta' dipeptidyl peptidase 4 (DPP-4) .
English: • Once activated, store your Lyxumia pen below 30°C.
Maltese: • Ladarba ġiet attivata, aħżen il-pinna Lyxumia tiegħek f'temperatura taħt 30°C.
English: Lyxumia 10 micrograms solution for injection EU/1/12/811/001 (1 pre-filled pen)
Maltese: Lyxumia 10 mikrogrammi soluzzjoni għall-injezzjoni EU/1/12/811/001 (pinna 1 mimlija għal-lest)
English: Overall, 37% of the patients were ≥75 years old (N=131) and 31% had moderate renal impairment (N=107).
Maltese: Fit-total, Overall, 37% tal-pazjenti kellhom ≥75 sena (N=131) u 31% kellhom indeboliment renali moderat (N=107).
English: CV: cardiovascular, MI: myocardial infarction, HF: hospitalization for heart failure, Revasc: coronary revascularization procedure, HR: hazard ratio, CI: confidence interval.
Maltese: KV: kardjovaskulari, IM: infart mijokardijaku, HF: bżonn ta' sptar minħabba insuffiċjenza tal-qalb, Revasc: proċedura ta' vaskularizzazzjoni koronarja mill-ġdid, HR: hazard ratio, CI: intervall ta'
English: Allergic reactions have been reported in 0.4% of Lyxumia patients.
Maltese: Reazzjonijiet allerġiċi ġew irrapportati f'0.4% tal-pazjenti li kienu qed jingħataw Lyxumia.
English: Cardiac arrhythmias particularly tachycardia (0.8% vs <0.1%) and palpitations (1.5% vs 0.8%) have been reported in lixisenatide patients compared to placebo treated patients.
Maltese: Ġew irrapportati arritmiji kardijaċi b'mod partikulari takikardija (0.8% kontra <0.1%) u palpitazzjonijiet (1.5% vs 0.8%) f'pazjenti fuq lixisenatide meta mqabbla ma' pazjenti kkurati bil-plaċebo.
English: 1 pre-filled pen of 3 ml (14 doses)
Maltese: INDIVIDWALI 3 ml (14-il doża)
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany
Maltese: Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Il-Ġermanja
English: 5.2 Pharmacokinetic properties
Maltese: 5.2 Tagħrif farmakokinetiku Assorbiment
English: Needle Protective seal
Maltese: Labra Siġill protettiv
English: In a pharmacokinetic study in elderly non-diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65 to 74 years and 7 subjects aged ≥75 years) compared to 18 subjects aged 18 to 45 years, likely related to reduced renal function in the older age group.
Maltese: Fi studju farmakokinetiku f'individwi anzjani li ma kellhomx id-dijabete, l-amministrazzjoni ta' 20 mcg lixisenatide wasslet għal żieda medja tal-AUC ta' lixisenatide b'29% fil-popolazzjoni anzjana (11-il pazjent ta' etajiet bejn 65 u 74 sena u 7 pazjenti b'età ≥ 75 sena) meta mqabbla ma' 18-il pazjent b'etajiet minn 18 sa 45-il sena, li x'aktarx kien relatat mal-funzjoni renali mnaqqsa fil-grupp ta' l-akbar età.
English: Reduction from baseline in the AUC0:30-4:30 h of plasma glucose after a test meal was: -12.61 h*mmol/L (-227.25 h*mg/dl) in the lixisenatide group and -4.04 h*mmol/L (-72.83 h*mg/dl) in the liraglutide group.
Maltese: Tnaqqis mill-linja bażi fl-AUC0:30-4:30h tal-glukosju fil plażma wara ikla mogħtija bħala test kien: -12,61 h*mmol/L (-227.25 h*mg/dl) fil-grupp lixisenatide u4.04 h*mmol/L (-72.83 h*mg/dl) fil-grupp liraglutide.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Maltese: Fi studji in vitro, lixisenatide ma affettwax l-attività ta' cytochrome P450 isozymes jew trasportaturi umani li ġew ittestjati.
English: There was no cross-reactivity versus either native glucagon or endogenous GLP-1.
Maltese: Ma kien hemm l-ebda reattività mpartat kontra l-glucagon nattiv jew GLP-1 endoġenu.
English: The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours.
Maltese: Tmax ta' ramipril u ramiprilat kien ittardjat b'madwar 2.5 sigħat.
English: Excipients: glycerol 85%, sodium acetate trihydrate, methionine, metacresol (see leaflet for further information), hydrochloric acid and sodium hydroxide solution (for pH adjustment), water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: glycerol 85%, sodium acetate trihydrate, methionine, metacresol (ara l-fuljett għal aktar informazzjoni), hydrochloric acid u soluzzjoni ta' sodium hydroxide (għall-aġġustament tal-pH), ilma għall-injezzjonijiet.
English: Step F. Repeat all steps in Section 3 for each injection.
Maltese: Step F Irrepeti l-proċeduri kollha f'Sezzjoni 3 għal kull injezzjoni.
English: Mean HbA1c (±SD) in the lixisenatide and placebo groups was 7.72 (±1.32)% and 7.64 (±1.28)% at baseline and 7.46 (±1.51)% and 7.61 (±1.48)% at 24 months, respectively.
Maltese: 32)% u ta' 7.64 (±1.28)% fil-linja bażi u ta' 7.46 (±1.51)% u 7.61 (±1.48)% fl-24 xahar, rispettivament.
English: • oral antidiabetics (such as metformin, pioglitazone, sulphonylurea medicines) and/ or ,
Maltese: • antidijabetiċi li jittieħdu mill-ħalq (bħal metformin, pioglitazone, mediċini tat-tip sulphonylurea) u/