FrancophonIA/ELRC3.0 huggingface dataset:
English: Glibenclamide is strongly bound to plasma albumin (99%), which may account for certain drug interactions, but is not easily detached by acidic medicinal products.
Maltese: Glibenclamide jaqbad sewwa mal-albumin tal-plażma (99%) li jista' jkun responsabbli minn ċerti interazzjonijiet tal-mediċina, iżda mhux faċli li jinqala' permezz ta' prodotti mediċinali aċidiċi.
English: Adolescents are not in need of this oral suspension formulation.
Maltese: L-adolexxenti m'għandhomx bżonn ta' din il-formulazzjoni ta' suspensjoni orali.
English: The minimum active concentration for the effect is considered to be 30-50 ng/mL glibenclamide.
Maltese: Il-konċentrazzjoni attiva minima għall-effett hi kkunsidrata li hi 30-50 ng/mL glibenclamide
English: − in patients taking bosentan (see section 4.5)
Maltese: − f'pazjenti li qed jieħdu bosentan (ara sezzjoni 4.5)
English: Tetracycline antibiotics (such as doxycycline and minocycline) used to treat infections
Maltese: Antibijotiċi tetracycline(bħal pereżempju doxycycline u minocycline) użati għall-kura ta' infezzjonijiet
English: The median [IQR] dose of sulfonylurea fell over the follow-up with a median [IQR] dose of 0.30 mg/kg/day [0.14-0.53] mg/kg/day at one year and of 0.23 mg/kg/day [0.12-0.41 mg/kg/day] at 10 years, p=0.03).
Maltese: Id-doża medjana [IQR] ta' sulphonylurea niżlet tul is-segwitu b'doża medjana [IQR] ta' 0.30 mg/kg/jum [0.14-0.53] mg/kg/jum wara sena u ta' 0.23 mg/kg/jum [0.12-0.41 mg/kg/jum] wara 10
English: In patients on sulphonylurea alone, blood glucose control has been improved after transfer to sulfonylureas with median [IQR] HbA1c of 5.9% [5.4-6.5%] at 1 year vs 8.0 % [7.2-9.2 %] before transfer (p< 0.0001), and remained very well controlled after 10 years with a median [IQR] HbA1c of 6.4% [5.9-7.2 %].
Maltese: F'pazjenti fuq sulphonylurea biss, il-kontroll tal-glucose fid-demm tjieb wara trasferiment għal sulfonylureas b'HbA1c [IQR] medjana ta' 5.9% [5.4-6.5%] wara sena kontra 8.0 % [7.2-9.2%] qabel it-trasferiment (p< 0.0001), u baqa' kkontrollat tajjeb ħafna wara 10 snin b'HbA1c [IQR] medjana ta' 6.4% [5.9-7.2%].
English: - The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate”).
Maltese: - L-ingredjenti l-oħra huma: xanthan gum, hydroxyethylcellulose, lactic acid, purified water sodium citrate u sodium benzoate (E211) (ara sezzjoni 2 “AMGLIDIA” fih is-sodium u l-benzoate”).
English: Incorrect control of plasma sugar (see section 2 “Do not give AMGLIDIA”)
Maltese: Kontroll ħażin ta' zokkor fil-plażma (ara sezzjoni 2 “Tagħtix AMGLIDIA”)
English: Head to head comparative pharmacokinetic data following the application of glibenclamide suspension and micronised tablets are not available.
Maltese: Id-data farmakokinetika komparattiva ras għal ras wara l-applikazzjoni ta' glibenclamide suspensjoni u ta' pilloli mikronizzati mhijiex disponibbli.
English: Clarithromycin is an antibiotic used to treat certain infections
Maltese: Clarithromycin hu antibijotiku użat għattrattament ta' ċerti infezzjonijiet
English: The 1 mL syringe is thin and small and graduated in steps of 0.05 mL.
Maltese: Is-siringa ta' 1 mL hi rqiqa u żgħira u gradwata f'passi ta' 0.05 mL.
English: After switching from glibenclamide tablets to AMGLIDIA suspension, there was no significant change in glycaemic control as evidenced from the similar serum HbA1c (6.5 vs 6.1% at Visits M0 and M4, respectively; p=0.076) and fructosamine (283.4 vs 271.2 µmol/L at Visits M0 and M4, respectively; p=0.55) mean concentrations.
Maltese: Wara li qalbu minn glibenclamide pilloli għal suspensjoni AMGLIDIA, ma kien hemm l-ebda bidla sinifikanti fil-kontroll gliċemiku kif evidenzjat mill-konċentrazzjonijiet medji tas-serum simili ta' HbA1c (6.5 vs 6.1% fil-Viżti M0 u M4 rispettivament; p=0.076) u tal-fructosamine (283.4 vs
English: Neutropenia and transitory increased transaminases One child had punctually low leucocytes level, but close to the normal range (neutrophils 1.3×103/µL for a lower limit of normal of 1.5×103/µL).
Maltese: Newtropenija u transaminases miżjuda b'mod tranżitorju Wild wieħed kellu livelli ta' lewkoċiti puntwalment baxxi, iżda viċin il-medda normali (neutrophils 1.3×103/µL għal limitu baxx tan-normal ta' 1.5×103/µL).
English: Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins, include oral anticoagulants, phenytoin, salicylates and other non-steroidal anti-inflammatory agents.
Maltese: glibenclamide minħabba l-ispostament ta' glibenclamide minn mal--proteini tal-plażma, jinkludu antikoagulanti, phenytoin, salicylates u aġenti antinfjammatorji nonsterojdali.
English: Acetazolamide (used to treat glaucoma)
Maltese: Acetazolamide (użat għall-kura ta'
English: − in patients with porphyria;
Maltese: − f'pazjenti b'porfirja;
English: Calcium channel blockers
Maltese: Imblokkaturi tal-kanali tal-kalċju
English: Chloramphenicol (in case of oral route) is an antibiotic used to treat infections
Maltese: Chloramphenicol (f'każ ta' rotta orali) hu antibijotiku użat għat-trattament ta'
English: None of patients experienced deterioration in glycaemic control, defined as an increase of HbA1c by > 0.5% and exceeding 5.6% in patients with baseline HbA1c ≤ 5.6% or an increase of HbA1c by > 0.5% in patients with baseline HbA1c > 5.6%.
Maltese: HbA1c b' > 0.5% u jaqbeż 5.6% f'pazjenti b'linja bażi ta' HbA1c ≤ 5.6% jew żieda ta' HbA1c b'> 0.5% f'pazjenti b'linja bażi ta' HbA1c > 5.6%
English: Prior to launch of Amglidia in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of an educational material for Amglidia, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel ma jintroduċi Amglidia f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) għandu jaqbel dwar il-kontenut u l-format ta' materjal edukattiv għal Amglidia, inkluż il mezzi ta' komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: In patients carrying a G6PD enzyme deficiency, cases of acute haemolytic anaemia have been reported with glibenclamide.
Maltese: F'pazjenti li jġorru defiċjenza fl-enżima G6PD, ġew rappurtati każijiet ta' anemija emolitika akuta bi glibenclamide.
English: Population pharmacokinetic approach was used to compare steady state concentrations following 0.9 mg twice daily in children with body weights between 10 - 30 kg and 1.25 mg twice daily in adults.
Maltese: (steady state) wara 0.9 mg darbtejn kuljum fit-tfal b'piż tal-ġisem bejn 10 - 30 kg u 1.25 mg darbtejn kuljum fl-adulti.
English: These values were approx. 40% greater than those obtained for the crushed tablet (148.34 ± 46.74 ng/mL).
Maltese: Il-valuri kienu bejn wieħed u ieħor 40% ikbar minn dawk miksuba għall-pillola mfarrka (148.34 ± 46.74 ng/mL).
English: Nicotinic acid (in high doses)
Maltese: Nicotinic acid (f'dożi għoljin)
English: Each mL contains 0.6 mg glibenclamide.
Maltese: Kull mL fih 0.6 mg glibenclamide.
English: How to store AMGLIDIA 6.
Maltese: Kif taħżen AMGLIDIA 6.
English: A comparative study of relative bioavailability between two suspensions of glibenclamide oral suspensions (0.6 mg/mL and 6 mg/mL) and crushed glibenclamide tablets (Daonil 5 mg) showed that when glibenclamide oral suspensions were administered, peak plasma concentrations of glibenclamide are reached 0.5 hours earlier than that observed with the crushed Daonil tablet (median value after administration is 2.5 hours compared to 3 hours).
Maltese: Studju komparattiv tal-bijodisponibilità relativa bejn żewġ suspensjonijiet ta' glibenclamide suspensjonijiet orali (0.6 mg/mL u 6 mg/mL) u glibenclamide pilloli mfarrka (Daonil 5 mg) wera li meta ngħataw glibenclamide suspensjonijiet orali, l-ogħla konċentrazzjonijiet ta' glibenclamide fil plażma jintlaħqu 0.5 sigħat iktar kmieni minn dawk osservati b'Daonil pillola mfarrka (valur medjan wara l-għoti hu ta' 2.5 sigħat meta mqabbel ma' 3 sigħat).
English: AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension
Maltese: AMGLIDIA 0.6 mg/mL suspensjoni orali AMGLIDIA 6 mg/mL suspensjoni orali
English: Quinolone antibiotics (such as nalidixic acid and ciprofloxacine) used to treat infections
Maltese: Antibijotiċi quinolone (bħal pereżempju nalidixic acid u ciprofloxacine) użati għall kura ta' infezzjonijiet
English: Thyroid hormones (such as L-thyroxin) used for hormonal treatment
Maltese: thyroxin) użati għat-trattament ormonali
English: ACE inhibitors (used to treat hypertension) (such as captopril and enalapril)
Maltese: Inibituri ACE (użati għall-għat-trattament ta' pressjoni għolja) (bħal pereżempju captopril u enalapril)
English: Ifosfamide used to treat different types of cancers
Maltese: Ifosfamide użat għat-trattament ta' tipi differenti ta' kanċer
English: The relative bioavailability was 121.6% for the 0.6 mg/mL suspension and 114.1% for the 6 mg/mL suspension compared to the crushed Daonil tablets.
Maltese: mg/mL u 114.1% għas-suspensjoni 6 mg/mL meta mqabbla ma' Daonil pilloli mfarrka.
English: Salicylates (such as aminosalicylic acid, para-aminosalicylic acid used for tuberculosis)
Maltese: Salicylates (bħal pereżempju Cyclophosphamidesużati għat-tuberkulożi)
English: Repeat the same protocol every day until insulin independence is achieved.
Maltese: Irrepeti l-istess protokoll kuljum sakemm tinkiseb indipendenza tal-insulina.
English: This medicine contains 5 mg benzoate salt in each mL oral suspension.
Maltese: Din il-mediċina fiha 5 mg benzoate salt f'kull mL suspensjoni orali.
English: Phenothiazine derivatives (such as chlorpromazine) used to treat schizophrenia and other psychoses
Maltese: Derivattivi tal-phenothiazine (bħal pereżempju chlorpromazine) użati għattrattament ta' skizofrenija u psikożi oħrajn
English: In a phase II, single-centre, prospective, open-label, non-randomised study, acceptability, efficiency and tolerance of the switch from crushed tablets to Amglidia suspension were measured.
Maltese: fażi, b'ċentru wieħed, prospettiv, open-label, fejn il-parteċipanti ma ġewx magħżula b'mod arbitrarju.
English: Anabolic steroids and male sex hormones (such as testosterone enanthate) (used to treat testosterone deficiency)
Maltese: Sterojdi anaboliċi u l-ormoni tas-sess maskili(bħal pereżempju t-testosterone enanthate) (użati fit-trattament ta'
English: No interaction studies have been performed for the two oral suspensions of glibenclamide (0.6 mg/mL and 6 mg/mL).
Maltese: Ma sar l-ebda studju dwar l-interazzjoni għaż-żewġ suspensjonijiet orali ta' glibenclamide (0.6 mg/mL u 6 mg/mL).
English: AMGLIDIA is a white and odourless oral suspension.
Maltese: AMGLIDIA hu suspensjoni orali bajda u bla riħa.
English: • Amglidia is a suspension to be administered with a provided oral syringe graduated in mL.
Maltese: • Amglidia hu suspensjoni li trid tingħata b'siringa orali gradwata f'mL provduta.
English: The 5 mL syringe is thick and long and graduated in steps of 0.1 mL.
Maltese: Is-siringa ta' 5 mL hi ħoxna u twila u gradwata f'passi ta' 0.1 mL.
English: EU/1/18/1279/001 (AMGLIDIA 0.6 mg/mL oral suspension with 1 mL oral syringe) EU/1/18/1279/002 (AMGLIDIA 0.6 mg/mL oral suspension with 5 mL oral syringe) EU/1/18/1279/003 (AMGLIDIA 6 mg/mL oral suspension with 1 mL oral syringe) EU/1/18/1279/004 (AMGLIDIA 6 mg/mL oral suspension with 5 mL oral syringe)
Maltese: UE/1/18/1279/001 (AMGLIDIA 0.6 mg/mL suspensjoni orali b'siringa orali ta' 1 mL.
English: Seventy-five patients (93%) remained on sulphonylurea alone at most recent follow-up and 6/81(7%) were on sulphonylurea and daily insulin.
Maltese: Ħamsa u sebgħin pazjent (93%) baqgħu fuq sulphonylurea biss fl-iktar segwitu riċenti u 6/81(7%) kienu fuq sulphonylurea u fuq l-insulina ta' kuljum.
English: Give basal and bolus insulin as usual on Day 1.
Maltese: Agħti insulina bażali u bolus bħas-soltu f'Jum 1.
English: Phenytoin used to treat epilepsy
Maltese: Phenytoin użat biex jitratta l-epilessija
English: Adverse reactions reported with glibenclamide (oral suspension or crushed tablets) in children, in the frame of treatment of neonatal diabetes are listed below by system organ class and frequency grouping.
Maltese: Reazzjonijiet avversi rappurtati bi glibenclamide (suspensjoni orali jew pilloli mfarrka) fit-tfal, filqafas tal-kura tad-dijabete fit-trabi tat-twelid huma mniżżla hawn taħt skont is-sistema tal-klassifika tal-organi u r-raggruppament ta' frekwenza.
English: This medicinal product contains 2.8 mg of sodium per mL oral suspension, equivalent to 0.1% of the WHO recommended daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 2.8 mg sodium għal kull mL suspensjoni orali, ekwivalenti għal 0.1% tad-doża ta' kuljum ta' 2 g sodium għal adult rakkomandata mill-Organizzazzjoni Dinjija tas-Saħħa (WHO).
English: Anabolic steroids and male sex hormones
Maltese: Sterojdi anaboliċi u l ormoni tas-sess maskili
English: − hypersensitivity to the active substance, other sulphonylureas or sulphonamides or to any of the excipients listed in section 6.1;
Maltese: − Sensittività eċċessiva għas-sustanza attiva, għal sulphonylureas oħrajn jew għal sulphonamides jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1:
English: Reduction of glibenclamide absorption from the gastrointestinal tract
Maltese: Disturbi gastrointestinali
English: Incorrect control of plasma glucose
Maltese: Kontroll ħażin tal-glucose filplażma
English: Sulphonylureas like AMGLIDIA have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Maltese: Sulphonylureas bħal AMGLIDIA intwerew li huma effettivi f'pazjenti b'mutazzjonijiet fil-ġeni li jikkodifikaw għall-kanal tal-potassium sensittiv għall-ATP taċ-ċelloli β u għad-dijabete mellitus temporanja fit-trabi tat-twelid relatata mal-kromosoma 6q24.
English: Skin rash, pruritus, urticaria, allergic skin reaction.
Maltese: Raxx fil-ġilda, ħakk, urtikarja u reazzjoni allerġika fil-ġilda.
English: EXP
Maltese: ATP.
English: If capillary blood glucose is < 7 mmol/L, do not increase AMGLIDIA and reduce pre-meal insulin boluses by 50%.
Maltese: Jekk il-glucose fid-demm kapillari jkun < 7 mmol/L, iżżidx AMGLIDIA u naqqas il-bolusis tal-insulina qabel l-ikel b'50 %.
English: Fibrates (such as bezafibrate, fenofibrate, gemfibrozil used to lower the level of fats)
Maltese: Fibrates (bħal pereżempju bezafibrate, fenofibrate, gemfibrozil użati biex jitnaqqsu l-livelli ta' xaħmijiet)
English: Ten patients were switched to glibenclamide oral suspension and treatment with oral suspension continued for 3 months.
Maltese: Għaxar pazjenti inqalbu fuq glibenclamide suspensjoni orali u t-trattament bis-suspensjoni orali kompliet għal 3 xhur.
English: • A Prescriber's Guide, including the SmPC of Amglidia attached
Maltese: • A Prescriber's Guide, (Gwida għall-Preskrivent), inkluż l-SmPC ta' Amglidia mehmuż Il-Prescriber's Guide (Il-Gwida għall-Preskrivent) għandu jkun fih il-messaġġi ewlenin li ġejjin:
English: MAO inhibitors
Maltese: Inibituri MAO
English: Each mL contains 6 mg glibenclamide.
Maltese: Kull mL fih 6 mg glibenclamide.
English: Coumarin derivatives (such as dicoumarol, acenocoumarol) used to decrease the clotting ability of the blood
Maltese: Derivattivi ta' coumarin (bħal pereżempju dicoumarol, acenocoumarol) użati biex titnaqqas l-abilità ta' koagulazzjoni taddemm
English: Transitory diarrhea Abdominal pain Vomiting Dyspepsia
Maltese: Dijarea tranżitorja Uġigħ addominali
English: AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension glibenclamide
Maltese: AMGLIDIA 0.6 mg/mL suspensjoni orali AMGLIDIA 6 mg/mL suspensjoni orali glibenclamide
English: Thyroid hormones
Maltese: Ormoni tat-tirojde
English: How to store AMGLIDIA
Maltese: X'fih AMGLIDIA
English: Bullous eruptions, exfoliative dermatitis, erythema multiforme have occasionally been reported in adults.
Maltese: Okkażjonalment fl-adulti ġew rappurtati eruzzjonijiet bullużi, dermatite bil-qxur, eritema multiforme.
English: Sulphonylureas will act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels.
Maltese: Sulphonylureas jaġixxu fuq ċelloli beta fil-frixa billi jinibixxu kanali tal-potassium sensittivi għal
English: If on insulin pump, reduce basal rate of insulin pump by 50% and reduce further in accordance with capillary blood-glucose measurements.
Maltese: Jekk fuq pompa tal insulina, naqqas ir-rata bażali tal-pompa tal-insulina b'50 % u naqqas aktar skont il-kejl tal-glucose fid-demm kapillari.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: AMGLIDIA contains the active substance called glibenclamide which belongs to a group of medicines called sulphonylureas used for lowering blood sugar (blood-glucose).
Maltese: AMGLIDIA fih is-sustanza attiva msejħa glibenclamide li tappartjeni għal grupp ta' mediċini msejħa sulphonylureas użati biex ibaxxu z-zokkor fid-demm (glucose fid-demm).
English: In any other cases, AMGLIDIA 6 mg/mL should be preferred.
Maltese: F'każijiet oħra, għandu jkun preferut AMGLIDIA 6mg/mL.
English: This medicine contains 2.80 mg of sodium per mL.
Maltese: Din il-mediċina fiha 2.80 mg ta' sodium għal kull mL.
English: Glibenclamide has been shown to be effective in patients with mutations in the genes coding for the βcell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Maltese: Glibenclamide wera li hu effettiv f'pazjenti b'mutazzjonijiet fil- ġeni li jikkodifikaw għall-kanal tal potassium sensittiv għall-ATP taċ-ċelloli β u għad-dijabete mellitus tranżitorja fit-trabi tat-twelid relatata mal-kromosoma 6q24.
English: AMGLIDIA 6 mg/mL oral suspension Each mL contains 6 mg glibenclamide.
Maltese: AMGLIDIA 6 mg/mL suspensjoni orali Kull mL fih 6 mg glibenclamide.
English: Daily doses ranged from 0.1 to 0.8 mg/kg for glibenclamide tablets (median dose, 0.3 mg/kg) and from 0.1 to 0.6 mg/kg for oral suspension (median 0.1 to 0.2 mg/kg/day over the study period) given in 2 to 4 administration per day).
Maltese: u minn 0.1 sa 0.6 mg/kg għas-suspensjoni orali (medjan 0.1 sa 0.2 mg/kg/jum matul il-perjodu tal istudju) mogħtija f'2 sa 4 għotjiet kuljum).
English: AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide.
Maltese: AMGLIDIA 0.6 mg/mL suspensjoni orali Kull mL fih 0.6 mg glibenclamide.
English: Care should be taken when prescribing and administering AMGLIDIA to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL).
Maltese: Għandha tingħata attenzjoni meta tinħareġ riċetta ta' tabib u meta jingħata AMGLIDIA biex jiġu evitati żbalji fid-dożaġġ dovuti għal konfużjoni bejn milligramma (mg) u mililitru (mL).
English: If a hypoglycaemic coma is diagnosed or suspected, the patient should quickly receive an intravenous injection of concentrated glucose solution (0.5 g/kg body weight as a 30% glucose solution).
Maltese: Jekk tiġi rikonoxxuta jew suspettata koma ipoglikimika, il-pazjent għandu jirċievi malajr injezzjoni fil-vina b'soluzzjoni ta' glucose konċentrat (0.5 g/kg piż tal-ġisem bħala 30% soluzzjoni ta' glucose).
English: The most serious adverse reaction is hypoglycemia (see section 4.4).
Maltese: Ir reazzjoni avversa l-iktar serja hi l-ipogliċemija (ara sezzjoni 4.4).
English: Hypereosinophilia, leucopenia, mild or severe thrombocytopenia, which can lead to purpura.
Maltese: Hypereosinophilia, lewkopenja, tromboċitopenja ħafifa jew severa, li tista' twassal għal purpura.
English: (In rare cases, it has taken 4 months to wean off insulin completely).
Maltese: (F'każijiet rari, ittieħdu 4 xhur biex twaqqfet id-dipendenza fuq l-insulina kompletament).
English: Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity.
Maltese: Glibenclamide jista' jżid il-konċentrazzjoni tal-plażma ta' ciclosporin u potenzjalment iwassal għażżieda fit-tossiċità tiegħu.
English: Probenecid used to treat gout, gouty arthritis Blood sugar levels too low Progestogens (such as desogestrel, dydrogesterone) used for hormonal treatment
Maltese: Progestogens (bħal pereżempju desogestrel, dydrogesterone) użati għat-trattament ormonali
English: o For major surgery, insulin therapy should replace AMGLIDIA; o Hepatic or renal dysfunction may require a reduction in dosage; o In exceptional situations of stress (e.g. trauma, surgery, febrile infections), blood-glucose regulation may deteriorate, and a temporary change to insulin may be necessary to maintain good metabolic control.
Maltese: o Għal kirurġija maġġuri, it-terapija bl-insulina għandha tissostitwixxi AMGLIDIA; o Id-disfunzjoni tal-fwied jew tal-kliewi tista' tenħtieġ tnaqqis fid-dożaġġ; o F'sitwazzjonijiet ta' eċċezzjoni ta' stress (eż. trawma, kirurġija, infezzjonijiet bid-deni), ir regolazzjoni tal-glucose fid-demm tista' tiddeterjora, u jista' jkun hemm bżonn ta' bidla temporanja għall-insulina biex jinżamm kontroll metaboliku tajjeb.
English: If capillary blood glucose is < 7 mmol/L reduce insulin.
Maltese: Jekk il-glucose fid-demm kapillari jkun < 7 mmol/L, naqqas linsulina.
English: Pack sizes
Maltese: jitkompla.
English: The 5 mL syringe has to be used for volumes greater than 1 mL.
Maltese: Is-siringa ta' 5 mL trid tintuża għal volumi ikbar minn 1 mL.
English: In repeated dose toxicity studies with oral administration of high doses of glibenclamide, effects on pancreatic beta-cells were observed (enlargement of the islets of Langerhans with irregularly configured islets and reduction in pancreatic β-cell granulation in rats at doses of ≥ 30 mg/kg/day, beta-cell exhaustion as indicated by depletion of insulin-containing granules in rabbits at doses of > 100 mg/kg/day).
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Fi studji tat-tossiċità b'doża ripetuta bl-għoti orali ta' dożi għoljin ta' glibenclamide, ġew osservati effetti fuq iċ-ċelloli beta tal-frixa (tkabbir tal-gżejjer ta' Langerhans bi gżejjer konfigurati b'mod irregolari u tnaqqis fil-bċejjeċ żgħar taċ-ċelloli-β fil-frixa fil-firien f'dożi ta' ≥ 30 mg/kg/jum,
English: Patients with complications were older at age of transfer to sulfonylurea than those without complications (median age at transfer: 20.5 v 4.1 years, p=0.0005).
Maltese: Il-pazjenti b'kumplikazzjonijiet kienu ikbar fl-età tat-trasferiment għal sulfonylurea minn dawk mingħajr kumplikazzjonijiet (l-età medjana fit-trasferiment 20.5 v 4.1 snin, p=0.0005).
English: Kidney failure does not affect its elimination as long as creatinine clearance remains above 30 ml/min.
Maltese: Il-falliment tal-kliewi ma jaffettwax l-eliminazzjoni tiegħu sakemm il-clearance tal-kreatina tibqa 'il fuq minn 30 ml/min.
English: The syringe is packed in a transparent bag.
Maltese: Is-siringa hi ppakkjata f'borża trasparenti.
English: With respect to the 2nd and 3rd trimester published data did not find fetotoxic effects.
Maltese: Fir-rigward tat-tieni u tat-tielet trimestru, id-data ppubblikata ma sabitx effetti fetotossiċi.
English: Blood-glucose should be monitored periodically throughout treatment with glibenclamide.
Maltese: Il-glucose fid-demm għandu jiġi mmonitorjat perjodikament tul it-trattament bi glibenclamide.