FrancophonIA/ELRC3.0 huggingface dataset:
English: An updated RMP should be submitted:
Maltese: Dan it-trej fih:
English: The average volume of distribution for fentanyl at steady state is 6 L/kg, the average clearance is 53 L/h.
Maltese: L/kg, l-eliminazzjoni medja hija 53 L/h.
English: Using IONSYS
Maltese: Applikazzjoni ta' IONSYS
English: In a rat study fentanyl did not influence male fertility.
Maltese: Fi studju fuq il-firien, fentanyl ma influwenzax il-fertilità tal-irġiel.
English: Currently available data are described in section 4.8, but no recommendation on posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: IONSYS should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Maltese: IONSYS għandu jingħata b'attenzjoni lil pazjenti b'indeboliment epatiku jew renali sever (ara sezzjoni 4.4).
English: Before you use IONSYS 3.
Maltese: 3. Applikazzjoni ta' IONSYS
English: Among these patients, the incidence of nausea was similar to adult patients; however, vomiting (32.1%) and fever (60.7%) were each reported at a higher incidence in paediatric patients relative to adults.
Maltese: (32.1 %) u deni (60.7 %) kienu rrapportati kull wieħed b'inċidenza ogħla f'pazjenti pedjatriċi b'rabta mal-adulti.
English: Topical medicines
Maltese: TAL-PRODOTT MEDIĊINALI
English: • you are taking medicines that might make you sleepy such as sleeping tablets, tranquilisers, medicines for anxiety or medicines for allergies (anti-histamines);
Maltese: • qed tieħu mediċini li jistgħu jqabbduk in-ngħas bħal pilloli għall-irqad, kalmanti, mediċini għall-ansjetà jew mediċini għall-allerġiji (anti-istamini);
English: Significant respiratory depression may occur with IONSYS; patients must be observed for these effects (see section 4.9).
Maltese: Dipressjoni respiratorja sinifikanti tista' sseħħ b'IONSYS; il-pazjenti għandhom jiġu osservati għal dawn l-effetti (ara sezzjoni 4.9).
English: The recommended dose Each dose of IONSYS delivers 40 micrograms of fentanyl.
Maltese: Id-doża rrakkomandata Kull doża ta' IONSYS tagħti 40 mikrogramma ta' fentanyl.
English: IONSYS 40 micrograms per dose transdermal system fentanyl
Maltese: IONSYS 40 mikrogramma għal kull doża sistema li tgħaddi l-mediċina minn ġol-ġilda
English: In this study 28 paediatric patients, 6 to 16 years old, were treated with IONSYS fentanyl 40 micrograms after experiencing inadequate analgesia with IONSYS fentanyl 25 micrograms.
Maltese: 40 mikrogramma wara li esperjenzaw analġeżija inadegwata b'IONSYS fentanyl 25 mikrogramma.
English: This leaflet was last revised in MM/YYYY
Maltese: Struzzjonijiet għall-użu u r-rimi
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Maltese: possibbilment b'passaġġ respiratorju orofarinġeali jew tubu endotrakeali.
English: • anaemia (low blood count)
Maltese: • anemija (għadd tad-demm baxx)
English: The controller is made of white plastic with the identifier “IONSYS” and has a digital display, a light window, and a dosing button.
Maltese: Il-kontrollur huwa magħmul minn plastik abjad bl-identifikatur “IONSYS” u għandu displej diġitali, tieqa tad-dawl, u buttuna għad-dożaġġ.
English: With intravenous administration, the initial distribution half-life is approximately 6 minutes; the second distribution half-life is 1 hour, and the terminal half-life is 13 hours.
Maltese: B'għoti ġol-vina, in-nofs ħajja ta' distribuzzjoni inizjali hija madwar 6 minuti; it-tieni nofs ħajja ta'
English: Mechanism of action
Maltese: Sistema
English: Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant.
Maltese: Ittabib tiegħek ser jiddiskuti r-riskji possibbli u l-benefiċċji potenzjali li tuża
English: Each dose of IONSYS delivers 40 micrograms of fentanyl over a 10 minute period, to a maximum of 240 micrograms per hour (6 doses each of 10 minutes duration).
Maltese: 240 mikrogramma fis-siegħa (6 dożi li kull waħda minnhom tieħu 10 minuti).
English: Study No.
Maltese: Kontrollur.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to / are provided with the following items:
Maltese: IONSYS, il-professjonisti kollha fil-kura tas-saħħa li huma mistennija li jippreskrivu, jiddispensaw jew jagħtu IONSYS jiġu infurmati permezz ta' ittra ta'
English: NAME OF THE MEDICINAL PRODUCT IONSYS 40 micrograms per dose transdermal system Fentanyl
Maltese: Informazzjoni għall-pazjent IONSYS 40 mikrogramma għal kull doża sistema li tgħaddi l-mediċina minn ġol-ġilda fentanyl
English: In these studies, 1313 patients undergoing major surgery were randomized to PCA with intravenous morphine (1 mg morphine bolus, 5 minute lock-out, total of 10 mg/h) delivered by a pump, and 1288 patients were randomized to IONSYS.
Maltese: F'dawn l-istudji, 1313-il pazjent li saritilhom operazzjoni ewlenija kienu randomizzati għal PCA b'morfina mogħtija ġol-vina (1 mg ta' injezzjoni f'daqqa ġol-vina ta' morfina, lock-out ta'
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Maltese: Fentanyl huwa lipofiliku ħafna u huwa distribwit sew barra mis-sistema vaskulari, b'volum kbir evidenti ta' distribuzzjoni.
English: IONSYS should be removed prior to certain procedures such as cardioversion (electrical current used to restore normal heart rhythm), defibrillation (electric shock given to the heart) or diathermy (electrical current used in physical therapy or surgery).
Maltese: lura r-ritmu normali tal-qalb), defibrillazzjoni (xokk elettriku mogħti lill-qalb) jew dijatermija (kurrent elettriku użat fit-terapija fiżika jew il-kirurġija).
English: IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.
Maltese: IONSYS huwa sistema li tgħaddi l-mediċina minn ġol-ġilda (li għandu jiġi applikat fuq ġilda intatta) li fih mediċina analġeżika qawwija (mediċina għas-serħan mill-uġigħ) imsejħa fentanyl.
English: Each tray is packaged in a folding cardboard carton.
Maltese: Kull trej huwa ppakkjat f'kaxxa tal-kartun li tintlewa.
English: IONSYS Troubleshooting
Maltese: Disturbi psikjatriċi
English: • Information on the adequate use of the product with regards to medication errors (including accidental exposure), Device malfunction/failure, Product Disposal and Misuse/abuse/diversion/addiction and dependence.
Maltese: (inkluż espożizzjoni aċċidentali), malfuzjoni/ħsara fl-apparat, ir-Rimi tal-Prodott u Użu ħażin/abbuż/diverżjoni/vizzju u dipendenza.
English: • decreased appetite
Maltese: • nuqqas ta' aptit • ansjetà
English: Pruritus
Maltese: Disurja
English: Thus, the adverse reaction profile does not suggest a meaningful difference in safety compared to patients younger than 65 years of age.
Maltese: Għalhekk, il-profil tar-reazzjonijiet avversi ma jissuġġerixxix differenza sinifikanti fis-sigurtà meta mqabbel mal-pazjenti li għandhom anqas minn 65 sena.
English: The most commonly reported adverse reactions were nausea, vomiting, and application site reactions such as erythema and pruritus.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni kienu nawsja, rimettar, u reazzjonijiet fis-sit tal-applikazzjoni bħal eritema u ħakk.
English: • you are taking muscle relaxants (prescribed for back pain), or if you are undergoing general
Maltese: • qed tieħu rilassanti tal-muskoli (preskritti għall-uġigħ tad-dahar), jew jekk ser issirlek
English: 6 transdermal systems
Maltese: - Tħallix lis-sistema
English: These studies evaluated IONSYS vs. intravenous PCA morphine in various surgical procedures commonly seen in clinical practice.
Maltese: Dawn l-istudji evalwaw IONSYS meta mqabbel ma' morfina PCA mogħtija ġol-vina f'diversi proċeduri kirurġiċi li jintużaw b'mod komuni fil-prattika klinika.
English: Application site reaction Application site vesicles Pyrexia
Maltese: Disturbi gastro-intestinali Nawsja Rimettar
English: However, caution is advised when prescribing IONSYS in morbidly obese patients because they may be at increased risk of other comorbid respiratory conditions (i.e., sleep apnoea) potentially pre-disposing them to hypoventilation or more severe adverse reactions (see section 4.8).
Maltese: hija rrakkomandata attenzjoni meta IONSYS jingħata lil pazjenti b'obeżità patoloġika li jistgħu jkunu f'riskju akbar ta' kundizzjonijiet respiratorji ko-morbużi oħra (jiġifieri apnea waqt l-irqad) li potenzjalment jippredisponuhom għal ipoventilazzjoni jew reazzjonijiet avversi aktar severi (ara sezzjoni 4.8).
English: Norfentanyl is not pharmacologically active in animal studies.
Maltese: Norfentanyl mhuwiex farmakoloġikament attiv fl-istudji fl-annimali.
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Maltese: Studju tal-karċinoġeniċità (injezzjonijiet kuljum taħt il-ġilda ta' fentanyl hydrochloride għal sentejn f'firien ta' Sprague Dawley) ma induċa ebda sejba li tindika potenzjal onkoġeniku.
English: • IONSYS may be removed at any time.
Maltese: • IONSYS jista' jitneħħa fi kwalunkwe ħin.
English: Dysgeusia Hypoaesthesia
Maltese: GĦAMLA KWALITATTIVA
English: The sachet foil is comprised of a lamination of nylon, aluminium foil and a heat seal layer of a copolymer of polyethylene and polymethacrylic acid.
Maltese: Il-fojl tal-qartas jinkludi laminazzjoni tan-najlon, fojl talaluminju u saff issiġillat bis-sħana ta' kopolimeru tal-polyethylene u polymethacrylic acid.
English: The hospital staff will store IONSYS.
Maltese: Il-persunal mediku ser jarmi IONSYS użat.
English: The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients: three placebo-controlled studies and four active-controlled studies.
Maltese: L-effikaċja u s-sigurtà ta' IONSYS għall-kura ta' uġigħ akut ta' natura moderata sa severa wara operazzjoni kienu evalwati f'seba' studji kkontrollati f'1763 pazjenti
English: • you have abnormally slow bowel movements or severe constipation
Maltese: • għandek movimenti fl-imsaren bil-mod aktar min-normal jew stitikezza severa
English: 23-24 Tafarnaubach Industrial Estate Tredegar
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Nausea Vomiting
Maltese: Impediment fis-smigħ
English: Hypoxia
Maltese: Ipokalimja
English: Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Maltese: L-effetti fuq l-embriju kienu minħabba t-tossiċità tal-omm u mhux effetti diretti tas-sustanza fuq l embriju li qed jiżviluppa.
English: • The slow blinking green light means IONSYS is ready to
Maltese: • Għandha tiġi applikata sistema IONSYS waħda fi kwalunkwe
English: Supplemental intravenous opioid medication (fentanyl or morphine) was only allowed during the first 3 hours of IONSYS or PCA morphine treatment.
Maltese: (fentanyl jew morfina) kienet permessa biss matul l-ewwel 3 sigħat ta' kura b'IONSYS jew morfina PCA.
English: The green light will change from a slow flash rate to a rapid flash rate and the digital display will alternate between a rotating circle and the number of completed doses during the entire 10-minute dose delivery period.
Maltese: Id-dawl aħdar jinbidel minn rata ta' teptip bil-mod għal rata ta' teptip rapida u d-displej diġitali ser jalterna bejn ċirku li jdur u n-numru ta' dożi kompletati matul il-perjodu ta' għoti tad-doża ta' 10 minuti.
English: Migraine Paraesthesia Somnolence Syncope
Maltese: Armi s-sistema skont l-istruzzjonijiet fis-sezzjoni 6.6
English: The controller is white with the identifier ‘IONSYS®' and has a digital display, a light window, and a recessed dose activation button.
Maltese: Il kontrollur huwa abjad bl-identifikatur “IONSYS®” u għandu displej diġitali, tieqa tad-dawl, u buttuna minquxa għall-attivazzjoni tad-doża.
English: • swelling of the abdomen, diarrhoea, burping/belching
Maltese: • mard fil-pulmun • nefħa tal-addome, dijarea, tifwiq
English: IONSYS is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics
Maltese: (MAO) fi żmien 14-il jum peress li potenzjament sever u imprevedibbli mill-inibituri MAO ġie rapportat b'analġeżiċi tal-opjojdi.
English: Action required
Maltese: MANIFATTUR RESPONSABBLI
English: Abdominal distension Diarrhoea Eructation
Maltese: Pressjoni baxxa ortostatika
English: In general, the maximum serum fentanyl concentration occurs approximately 15 minutes after the initiation of a dose.
Maltese: fentanyl fis-serum iseħħu madwar 15-il minuta wara l-bidu ta' doża.
English: • You will know the 10-minute dosing period is complete when the fast blinking green light becomes slow again.
Maltese: • Ser tkun taf li d-doża ta' 10 minuti hija lesta meta d-dawl aħdar iteptep malajr jerġa' jibda jteptep b'dawl aħdar bilmod.
English: Injection site pain Oedema
Maltese: Email: medical.information@themedco.com
English: The flashing digital display may be turned off by pressing the dose button for six seconds.
Maltese: Id-displej diġitali li jteptep jista' jintefa billi tingħafas ilbuttuna tad-doża għal sitt sekondi.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h
Maltese: It-total ta' tneħħija mill-plażma ta' fentanyl wara għoti ġol-vina huwa ta' madwar 42 L/h Linearità/nuqqas ta' linearità
English: The dosing button must not be pressed.
Maltese: Biex tiġi evitata inġestjoni orali ta'
English: How to store IONSYS 6.
Maltese: Kif taħżen IONSYS 6.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Across the active-controlled studies, dosing with IONSYS was similar to intravenous PCA morphine pump use.
Maltese: Fl-istudji b'kontroll attiv kollha, id-dożaġġ b'IONSYS kien simili għall-użu ta' pompa tal-morfina
English: IONSYS should also be removed prior to a magnetic resonance imaging (MRI) procedure, X-ray or CT scan.
Maltese: IONSYS għandu jitneħħa wkoll qabel issir proċedura ta' immaġni tar-reżonanza manjetika (MRI), X-ray jew CT scan.
English: IONSYS will operate for 24 hours after the system is assembled or for 80 doses, whichever comes first, and then becomes inoperative.
Maltese: IONSYS ser jaħdem għal 24 siegħa wara li tiġi assemblata s-sistema jew għal 80 doża, skont liema jiġi l-ewwel, u mbagħad ma tibqax taħdem aktar.
English: • constipation, stomach pain
Maltese: • stitikezza, uġigħ ta' żaqq
English: For further details, see section 6.6.
Maltese: Għal aktar dettalji, ara sezzjoni 6.6.
English: • Gloves should be worn during the assembly/handling of IONSYS.
Maltese: • Għandhom jintlibsu ingwanti matul l-assemblaġġ/immaniġġjar ta' IONSYS.
English: What IONSYS is
Maltese: IONSYS:
English: • you are taking pain killers called partial agonists like buprenorphine, nalbuphine, pentazocine;
Maltese: • qed tieħu mediċini użati biex jgħinu fil-kura ta' nawsja u rimettar (bħal aprepitant);
English: Tell your patient the following:
Maltese: Assemblaġġ tal-għatu t'isfel:
English: The free fraction of fentanyl increases with acidosis.
Maltese: Għandhom jinżammu wkoll temperatura tal ġisem u teħid ta' fluwidi adegwati.
English: Published literature indicates potential for increased fentanyl exposure in patients with genetic polymorphisms affecting CYP3A4 and CYP3A5, with a small variability in concentrations with transdermal administration; therefore, IONSYS should be used with caution in these patients (see section 5.2)
Maltese: Id-dokumentazzjoni ppubblikata tindika potenzjal għal żieda fl-espożizzjoni potenzjali għal fentanyl f'pazjenti b'polimorfiżmi ġenetiċi li jaffettwaw CYP3A4 u CYP3A5, b'varjabbiltà żgħira filkonċentrazzjonijiet b'għoti minn ġol-ġilda; għalhekk, IONSYS għandu jintuża b'kawtela f'dawn il pazjenti (ara sezzjoni 5.2)
English: Application site pruritus
Maltese: Applika pressjoni bis-swaba'
English: 6.3 Shelf life
Maltese: • L-ebda dawl
English: • passing water (urinating) less frequently than normal • passing wind, difficulty passing stools
Maltese: • tgħaddi ilma (awrina) inqas frekwenti min-normal
English: Crospovidone Type A Magnesium stearate
Maltese: Crospovidone Tip A Magnesium stearate
English: ATC code: A10BD13.
Maltese: A10BD13.
English: FAS = full analysis set
Maltese: FAS = full analysis set - sett ta' analiżi sħiħa
English: The mean volume of distribution (Vd) ranged between 63-276 L.
Maltese: Il-volum medju ta' distribuzzjoni (Vd) varja bejn 63-276 L.
English: Lactic acidosis: 0.03 cases/1,000 patient-years (see section 4.4).
Maltese: Aċidożi lattika: 0.03 każijiet/1,000 sena ta' pazjent (ara sezzjoni 4.4).
English: Pack sizes of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 or multipacks containing 196 (2 packs of 98) film-coated tablets.
Maltese: Daqsijiet tal-pakketti ta' 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 jew pakketti multipli li fihom 196 (2 pakketti ta' 98) pillola miksja b'rita.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimula s-sintesi ta' glycogen intraċellulari billi jaġixxi fuq glycogen synthase.
English: Vipdomet with alcohol
Maltese: Vipdomet mal-alkoħol
English: EU/1/13/843/001 10 film-coated tablets EU/1/13/843/002 14 film-coated tablets EU/1/13/843/003 20 film-coated tablets EU/1/13/843/004 28 film-coated tablets EU/1/13/843/005 56 film-coated tablets EU/1/13/843/006 60 film-coated tablets EU/1/13/843/007 98 film-coated tablets EU/1/13/843/008 112 film-coated tablets EU/1/13/843/009 120 film-coated tablets EU/1/13/843/010 180 film-coated tablets EU/1/13/843/011 196 film-coated tablets EU/1/13/843/012 200 film-coated tablets
Maltese: EU/1/13/843/001 10 pilloli miksija b'rita EU/1/13/843/002 14-il pillola miksija b'rita EU/1/13/843/003 20 pillola miksija b'rita EU/1/13/843/004 28 pillola miksija b'rita EU/1/13/843/005 56 pillola miksija b'rita EU/1/13/843/006 60 pillola miksija b'rita EU/1/13/843/007 98 pillola miksija b'rita EU/1/13/843/008 112-il pillola miksija b'rita EU/1/13/843/009 120 pillola miksija b'rita EU/1/13/843/010 180 pillola miksija b'rita EU/1/13/843/011 196 pillola miksija b'rita EU/1/13/843/012 200 pillola miksija b'rita
English: EU/1/13/843/013 10 film-coated tablets EU/1/13/843/014 14 film-coated tablets EU/1/13/843/015 20 film-coated tablets EU/1/13/843/016 28 film-coated tablets EU/1/13/843/017 56 film-coated tablets EU/1/13/843/018 60 film-coated tablets EU/1/13/843/019 98 film-coated tablets EU/1/13/843/020 112 film-coated tablets EU/1/13/843/021 120 film-coated tablets EU/1/13/843/022 180 film-coated tablets EU/1/13/843/023 196 film-coated tablets EU/1/13/843/024 200 film-coated tablets
Maltese: EU/1/13/843/013 10 pilloli miksija b'rita EU/1/13/843/014 14-il pillola miksija b'rita EU/1/13/843/015 20 pillola miksija b'rita EU/1/13/843/016 28 pillola miksija b'rita EU/1/13/843/017 56 pillola miksija b'rita EU/1/13/843/018 60 pillola miksija b'rita EU/1/13/843/019 98 pillola miksija b'rita EU/1/13/843/020 112-il pillola miksija b'rita EU/1/13/843/021 120 pillola miksija b'rita EU/1/13/843/022 180 pillola miksija b'rita EU/1/13/843/023 196 pillola miksija b'rita EU/1/13/843/024 200 pillola miksija b'rita
English: crospovidone Type A, magnesium stearate, hypromellose, talc, titanium dioxide (E171) and yellow iron oxide (E172).
Maltese: Is-sustanzi mhux attivi l-oħra huma: mannitol, microcrystalline cellulose, povidone K30, crospovidone Tip A, magnesium stearate, hypromellose, talc, titanium dioxide (E171) u yellow iron oxide (E172).
English: Frequency of adverse reactions Alogliptin Metformin Vipdomet
Maltese: Frekwenza ta' reazzjonijiet avversi Alogliptin Metformin Vipdomet
English: Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing.
Maltese: Espożizzjoni total (AUC(0-inf)) għal alogliptin wara l-għoti ta' doża waħda kien simili għallespożizzjoni matul intervall ta' doża waħda (AUC (0-24)) wara 6 ijiem ta' dożaġġ ta' darba kuljum.
English: In clinical studies, alogliptin had no clinically relevant effect on the pharmacokinetics of caffeine, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, an oral contraceptive (norethindrone and ethinyl oestradiol), digoxin, fexofenadine, metformin, or cimetidine, thus providing in vivo evidence of a low propensity to cause interaction with substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2.
Maltese: Fi studji kliniċi, alogliptin ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika tal-kaffeina, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, kontraċettiv orali (norethindrone u ethinyl oestradiol), digoxin, fexofenadine, metformin, jew cimetidine, u b'hekk ingħatat evidenza in vivo ta' tendenza baxxa li jikkawża reazzjonijiet interattivi ma' sottostrati ta' CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, u OCT2.
English: Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Maltese: Riżultati minn studji b'metformin, pioglitazone (thiazolidinedione), voglibose (impeditur ta' alpha-glucosidase) u glyburide (sulphonylurea) ma wrew l-ebda interazzjoni farmakokinetika klinikament rilevanti.
English: In controlled clinical studies, maximum metformin plasma levels (Cmax) did not exceed 4 microgram/mL even at maximum doses.
Maltese: Fi studji kliniċi kkontrollati, livelli massimi ta' metformin fil-plażma (Cmax) ma qabżux 4 mikrogrammi/mL anke f'dożi massimi.
English: Alogliptin 25 mg once daily with insulin + metformin (n=126)
Maltese: Alogliptin 25 mg darba kuljum ma' insulina ± metformin (n = 126)
English: In studies in vitro, alogliptin was found to be neither a substrate nor an inhibitor of key transporters associated with disposition of the active substance in the kidney: organic anion transporter-1, organic anion transporter-3 or organic cationic transporter-2 (OCT2).
Maltese: Fi studji in vitro, alogliptin instab li la huwa sottostrat u lanqas impeditur ta' trasportaturi ewlenin assoċjati ma' dispożizzjoni tas-sustanza attiva fil-kliewi: trasportatur anijoniku organiku-1, trasportatur anijoniku organiku-3 jew trasportatur katijoniku organiku-2 (OCT2 - organic cationic transporter-2).
English: Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Maltese: Eliminazzjoni Alogliptin ġie eliminat b'half-life terminali medja (T1/2) ta' madwar 21 siegħa.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets.
Maltese: U KONTENUT Pakkett multiplu: 196 (2 pakketti ta' 98) pillola miksija b'rita.
English: Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Maltese: Età (65-81 sena), sess, razza (abjad, iswed u Ażjan) u l-piż tal-ġisem ma kellhom l-ebda effett klinikament rilevanti fuq il-farmakokinetiċi ta' alogliptin.