FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant presented a pivotal and a supportive uncontrolled trial to support this indication, together with a protocol and preliminary data for another uncontrolled trial with similar design.
Maltese: L-Applikant ippreżenta prova pivotali u mhux ikkontrollata ta' appoġġ biex jappoġġa din lindikazzjoni, flimkien ma' protokoll u dejta preliminarja għal prova mhux ikkontrollata oħra bi tfassil simili.
English: The full EPAR for Elmiron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Elmiron
Maltese: Informazzjoni oħra dwar Elmiron
English: Elmiron pentosan polysulfate sodium
Maltese: Sommarju tal-EPAR għall-pubbliku pentosan polysulfate sodium
English: Elmiron contains the active substance pentosan polysulfate sodium.
Maltese: Elmiron fih is-sustanza attiva sodju tal-polisulfat pentosan.
English: Looking at the results of the 4 studies together, 1 in 3 (33%) patients taking pentosan polysulfate sodium showed an overall improvement in their condition compared with around 1 in 6 (16%) patients taking placebo (a dummy treatment).
Maltese: Meta wieħed iħares lejn ir-riżultati tal-4 studji flimkien, 1 minn 3 (33 %) pazjenti li ħadu pentosan polysulfate sodium urew titjib globali fil-kondizzjoni tagħhom meta mqabbel ma' madwar 1 minn 6 (16 %) pazjenti li ħadu l-plaċebo (kura finta).
English: Why is Elmiron approved?
Maltese: Għaliex ġie approvat Elmiron?
English: The most common side effects with Elmiron (which may affect up to 1 in 10 people) include headache, dizziness, and effects in the digestive systems such as diarrhoea, nausea (feeling sick), abdominal (belly) pain and bleeding from the rectum.
Maltese: L-effetti sekondarji l-aktar komuni b'Elmiron (li jistgħu jaffettwaw sa 1 minn kull 10) jinkludu wġigħ ta' ras, sturdament, u effetti fis-sistema diġestiva bħal dijarea, nawżja (tħossok ma tiflaħx), uġigħ addominali (fiż-żaqq) u fsada mir-rektum.
English: What are the risks associated with Elmiron?
Maltese: X'inhuma r-riskji assoċjati ma' Elmiron?
English: The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome.
Maltese: Il-mod kif taħdem is-sustanza attiva f'Elmiron, pentosan polysulfate sodium, għadu mhux mifhum għalkollox iżda din tgħaddi fl-awrina u huwa maħsub li teħel u tgħin biex issewwi s-saff protettiv ta' mukus madwar il-bużżieqa tal-awrina, li huwa mnaqqas f'pazjenti b'sindrome ta' uġigħ fil-bużżieqa talawrina.
English: The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall.
Maltese: L-istudji involvew total ta' 454 pazjent bi fsadi żgħar u leżjonijiet fil-ħajt tal-bużżieqa tal-awrina.
English: Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.
Maltese: Elmiron huwa mediċina li tintuża biex tikkura adulti b'sindrome ta' uġigħ fil-bużżieqa tal-awrina, kondizzjoni tal-bużżieqa tal-awrina li tikkawża wġigħ fil-parti pelvika u bżonn frekwenti u urġenti biex wieħed jgħaddi l-awrina.
English: Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature.
Maltese: Peress li pentosan polysulfate sodium huwa sustanza magħrufa sewwa, u l-użu tagħha fis-sindrome ta' uġigħ fil-bużżieqa tal-awrina huwa stabbilit sewwa, il-kumpanija għal Elmiron ippreżentat data milletteratura xjentifika.
English: A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
Maltese: Reviżjoni ta' 4 studji ewlenin mil-letteratura wriet li pentosan polysulfate sodium huwa effettiv biex inaqqas is-sintomi, bħal uġigħ u l-urġenza biex wieħed jgħaddi l-awrina b'mod frekwenti.
English: For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet kollha b'Elmiron, ara l-fuljett ta
English: Elmiron is available as 100-mg capsules and can only be obtained with a prescription.
Maltese: Elmiron jiġi bħala kapsuli ta' 100 mg u jista' jinkiseb biss b'riċetta ta' tabib.
English: How does Elmiron work?
Maltese: -użu ta' Elmiron.
English: This is a summary of the European public assessment report (EPAR) for Elmiron.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: What measures are being taken to ensure the safe and effective use of Elmiron?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Elmiron?
English: Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU.
Maltese: Is-sindrome ta' uġigħ fil-bużżieqa tal-awrina huwa kondizzjoni stressanti li għaliha, qabel, ma ġiet approvata l-ebda mediċina fl-UE.
English: No major safety concerns were identified, and the possible risk of bleeding can be minimised with appropriate precautions.
Maltese: Ma ġie identifikat l-ebda tħassib maġġuri dwar is-sigurtà, u r-riskju possibbli ta' fsada jista' jiġi mminimizzat bi prekawzjonijiet xierqa.
English: 5342 CC Oss
Maltese: 5342 CC
English: It may harm them,
Maltese: LUSDUNA huwa injettat taħt il-ġilda.
English: Glucose Utilization Rate* (mg/kg/min)
Maltese: Gluko sju* (mg/k g/min
English: Manufacturer NV Organon Molenstraat 110 5342 CC Oss The Netherlands
Maltese: NV Organon Molenstraat 110 5342 CC
English: The pen contains a total of 300 units.
Maltese: Il-pinna fiha total ta' 300 unità.
English: LUSDUNA 100 units/mL injection Nexvue
Maltese: LUSDUNA 100 unità/mL injezzjoni Nexvue
English: NPH insulin
Maltese: Insulina NPH
English: LUSDUNA is a biosimilar medicinal product.
Maltese: LUSDUNA huwa prodott mediċinali bijoloġiku simili.
English: EU/1/16/1162/002
Maltese: EU/1/16/1162/001 EU/1/16/1162/002 EU/1/16/1162/003
English: PEN LABEL -NEXVUE
Maltese: TIKKETTA TAL-PINNA - NEXVUE
English: OUTER CARTON - Packs of 1 and 5
Maltese: KARTUNA TA' BARRA - Pakketti ta' 1 u 5
English: Figure 1 above shows the activity profiles over time of insulin glargine and NPH insulin.
Maltese: Figura 1 hawn fuq turi il-profili ta' attività mal-ħin ta' insulin glargine u l-insulina NPH.
English: Each mL contains 100 units (3.64 mg) insulin glargine.
Maltese: Kull mL fih 100 unità (3.64 mg) ta' insulin glargine.
English: Lipohypertrophy Lipoatrophy Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (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:
Maltese: Ir-reazzjonijiet avversi relatati li ġejjin minn provi kliniċi huma elenkati taħt bħala t-terminu ppreferut ta' MedDRA skont il-klassi tas-sistemi u tal-organi u skont l-inċidenza tagħhom b'dawk li għandhom l-ogħla inċidenza mniżżla l-ewwel segwiti minn dawk b'inċidenza inqas (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).
English: Participants were randomized (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤ 95 mg/dL (5.3 mM), or standard care (n=6,273).
Maltese: Il-parteċipanti ġew assenjati b'mod każwali (1:1) biex jirċievu insulin glargine (n=6,264) li ġie titrat biex jilħaq FPG ≤ 95 mg/dL (5.3 mM), jew kura standard (n=6,273).
English: OUTER CARTON (with blue box) multipack - 10 (2 x 5)
Maltese: KARTUNA TA' BARRA (bil-kaxxa ċ-ċelesti) pakkett multiplu - 10 (2 x 5)
English: • LUSDUNA contains a medicine called insulin glargine.
Maltese: • LUSDUNA fih mediċina msejħa insulin glargine.
English: Excipients: zinc chloride, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Maltese: Eċċipjenti: zinc chloride, metacresol, glycerol, hydrochloric acid u sodium hydroxide (għallaġġustament tal-pH), ilma għall-injezzjonijiet.
English: What LUSDUNA contains - The active substance is insulin glargine.
Maltese: X'fih LUSDUNA - Is-sustanza attiva hi insulin glargine.
English: The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate ratio (95 % CI) = 1.18 (0.97-1.44)].
Maltese: L-iskop primarju, li jintwera li insulin glargine mhux inferjuri għal NPH f'kull każ ta' ipogliċemija ma ntlaħaqx u kien hemm xejra ta' żieda fl-avvenimenti ipogliċemiċi b'insulin glargine [insulin glargine: proporzjon tar-rata ta' NPH (CI ta' 95%) = 1.18 (0.97-1.44)].
English: At baseline, participants had a median HbA1c value of 6.4 % and median on-treatment HbA1c values ranged from 5.9 to 6.4 % in the insulin glargine group, and 6.2 % to 6.6 % in the standard care group throughout the duration of follow-up.
Maltese: Fil-linja bażi, ilparteċipanti kellhom valur medjan ta' HbA1c ta' 6.4 % u l-medjan tal-valuri ta' HbA1c waqt ittrattament varjaw minn 5.9 sa 6.4 % fil-grupp ta' insulin glargine, u 6.2 % sa 6.6 % fil-grupp ta' kura standard matul iż-żmien kollu ta' segwitu.
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Maltese: L-attività primarja tal-insulina, inkluża dik ta' insulin glargine, hija li tirregola l-metaboliżmu talglukosju.
English: Switch from insulin glargine 300 units/mL to LUSDUNA
Maltese: Bidla minn insulin glargine 300 unità/mL għal LUSDUNA
English: Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL.
Maltese: Pakkett multiplu: 10 (2 pakketti ta' 5) pinen mimlijin għal-lest ta' 3 mL.
English: INTERMEDIATE CARTON (without blue box) component of a multipack - 5 pens
Maltese: KARTUNA TAN-NOFS (mingħajr il-kaxxa ċ-ċelesti) komponent ta' pakkett multiplu - 5 pinen
English: LUSDUNA contains insulin glargine.
Maltese: LUSDUNA fih insulin glargine.
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Maltese: L-irbit mar-riċettur ta' IGF-1: L-affinità ta' insulin glargine għar-riċettur uman ta' IGF-1 hija madwar 5 sa 8 darbiet aktar minn dik tal-insulina umana (iżda madwar 70 sa 80 darba inqas minn dik ta' IGF-1), filwaqt li M1 u M2 jintrabtu mar-riċettur ta' IGF-1 b'affinità kemmxejn inqas meta mqabbla mal-insulina umana.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicentre, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12 % of participants) or type 2 diabetes mellitus treated with ≤ 1 antidiabetic oral agent (88 % of participants).
Maltese: L-istudju ORIGIN (Outcome Reduction with Initial Glargine INtervention) kien studju multiċentriku, każwali, b'tifsila 2x2 factorial, li sar fi 12,537 parteċipant b'riskju kardjovaskulari (CVcardiovascular) kbir u b'indeboliment fil-kontroll tal-glukosju fl-istat ta' sawm (IFG - impaired fasting glucose) jew b'indeboliment fit-tolleranza għall-glukosju (IGT - impaired glucose tolerance) (12% tal-parteċipanti) jew b'dijabete mellitus tat-tip 2 ittrattata b'sustanza antidijabetika orali ≤1 (88% tal-parteċipanti).
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Maltese: Ġeneralment, il-profil ta' sigurtà fit-tfal u fl-adolexxenti (età ≤ 18-il sena) huwa simili għall-profil ta' sigurtà għall-adulti.
English: Instructions for use online at www.lusdunanexvue.com
Maltese: Istruzzjonijiet onlajn dwar lużu jinsabu f'www.lusdunanexvue.com
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Maltese: Sustanzi li jistgħu jnaqqsu l-effett tat-tnaqqis tal-glukosju fid-demm jinkludu l-kortikosterojdi, danazol, diazoxide, id-dijuretiċi, glucagon, isoniazid, estroġeni u proġestoġeni, id-derivati ta' phenothiazine, somatropin, prodotti mediċinali simpatomimetiċi (eż. epinephrine [adrenalina], salbutamol, terbutaline), ormoni tat-tirojde, prodotti mediċinali antipsikotiċi atipiċi (eż. clozapine u olanzapine) u inibituri tal-protease.
English: *Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Maltese: *Insulin glargine huwa magħmul permezz ta' teknoloġija tat-tfassil tad-DNA ġo Escherichia coli.
English: Name and address of the manufacturer(s) responsible for batch release N.V. Organon
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott N.V. Organon
English: 5 pre-filled pens of 3 mL.
Maltese: 5 pinen mimlijin għal-lest ta' 3mL.
English: 1 pre-filled pen of 3 mL 5 pre-filled pens of 3 mL
Maltese: Pinna 1 mimlija għal-lest ta' 3 mL 5 pinen mimlijin għal-lest ta' 3 mL
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) ta' sodium f'kull doża, i.e. huwa essenzjalment “ħieles mis-sodium”.
English: For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available.
Maltese: Għal insulin glargine m'hemmx disponibbli data klinika minn studji kliniċi kkontrollati dwar l-użu waqt it-tqala.
English: MedDRA system organ
Maltese: sistemi u tal-organi
English: Store below30°C.
Maltese: 30°C).
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32 % in the insulin glargine / lispro group versus 52 % in the NPH / regular group.
Maltese: B'mod jaqbel ma' dan, linċidenza ta' ipogliċemija ta' matul il-lejl kienet ta' 32 % fil-grupp ta' insulin glargine/lispro versus 52 % fil-grupp tal-insulina
English: - concomitant treatment with certain other medicinal products (see section 4.5).
Maltese: - li qed jieħdu t-trattament flimkien ma' ċerti prodotti mediċinali oħra (ara sezzjoni 4.5).
English: EU/1/16/1162/003 10 (2 packs of 5) pre-filled pens of 3 mL
Maltese: EU/1/16/1162/003 10 (2 pakketti ta' 5) pinen mimlijin għal-lest ta' 3 mL
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group.
Maltese: Ir-rati ta' ipogliċemija severa (parteċipanti affettwati għal kull 100 sena ta' esponiment ta' parteċipant) kienu ta' 1.05 għal insulin glargine u 0.30 għall-grupp ta' kura standard u r-rati ta' ipogliċemija kkonfermata li ma kinitx severa kienu ta' 7.71 għal insulin glargine u 2.44 għall-grupp ta' kura standard.
English: EU/1/16/1162/001 1 pre-filled pen of 3 mL EU/1/16/1162/002 5 pre-filled pens of 3 mL
Maltese: EU/1/16/1162/001 pinna waħda mimlija għal-lest ta' 3 mL EU/1/16/1162/002 5 pinen mimlijin għal-lest ta' 3 mL
English: Exp Lot
Maltese: NUMRU TAL-LOTT
English: After subcutaneous injection in diabetic patients, insulin glargine is rapidly metabolised at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Maltese: M1 (21A-Gly-insulin) u M2 (21AGly-des-30B-Thr-insulin).
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Dejta disponibbli bħalissa hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5
English: Figure 1: Activity Profile in Patients with Type 1 Diabetes
Maltese: Figura 1: Il-Profil ta'Attività f'Pazjenti b'Dijabete tat-Tip 1
English: LUSDUNA contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Maltese: LUSDUNA fih insulin glargine, analogu tal-insulina, u jaħdem għal perjodu twil ta' żmien.
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogues and sulphonamide antibiotics.
Maltese: Sustanzi li jistgħu jżidu l-effett tat-tnaqqis tal-glukosju fid-demm u jżidu s-suxxettibilità għallipogliċemija jinkludu prodotti mediċinali mill-ħalq kontra d-dijabete, inibituri tal-enzima li tikkonverti anġjotensin (ACE - angiotensin converting enzyme), disopyramide, fibrati, fluoxetine, inibituri ta' monoamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates, l-analogi ta' somatostatin u lantibijotiċi sulfonamide.
English: Other medicines and LUSDUNA
Maltese: Kif taħżen LUSDUNA
English: It is completely soluble at the acidic pH of the LUSDUNA injection solution (pH 4).
Maltese: Hi tinħall għal kollox fil-pH aċiduża tas-soluzzjoni għall-injezzjoni ta' LUSDUNA (pH 4).
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat low blood sugar), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
Maltese: Mediċini li jistgħu jgħollu l-livell taz-zokkor fid-demm tiegħek (ipergliċemija) jinkludu: - kortikosterojdi (bħal "cortisone" użat għat-trattament tal-infjammazzjoni), - danazol (mediċina li taħdem fuq l-ovulazzjoni), - diazoxide (użat għat-trattament ta' zokkor baxx fid-demm), - dijuretiċi (użati għat-trattament ta' pressjoni għolja jew ta' żamma eċċessiva ta' fluwidu), - glukagon (ormon tal-frixa użat għat-trattament ta' ipogliċemija severa), - isoniazid (użat għat-trattament tat-tuberkulożi), - estroġeni u proġestoġeni (bħal fil-pillola kontraċettiva użata għall-kontroll tat-twelid), - derivattivi ta' phenothiazine (użati għat-trattament ta' disturbi psikjatriċi), - somatropin (ormon tat-tkabbir), - mediċini simpatomimetiċi (bħal epinephrine [adrenaline], salbutamol, terbutaline (użati għat
English: - The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Important information about some of the ingredients of LUSDUNA”), hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma: zinc chloride, metacresol, glycerol, sodium hydroxide (għallaġġustament tal-pH) (ara sezzjoni 2 “Tagħrif importanti dwar xi wħud mis-sustanzi ta' LUSDUNA”), hydrochloric acid (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study (see section 5.1).
Maltese: Il-farmakokinetika fi tfal b'età minn sentejn sa inqas minn 6 snin b'dijabete mellitus tat-tip 1 kienet evalwata fi studju kliniku wieħed (ara sezzjoni 5.1).
English: Packs of 1, 5 and a multipack with 10 (2 x 5) pre-filled pens are available.
Maltese: Huma disponibbli pakketti ta' pinna 1, 5 pinen u pakkett multiplu ta' 10 (2 x 5) pinen mimlija għal lest.
English: Cartridge (type I colourless glass) with a plunger (bromobutyl rubber) and aluminium combi-seal fitted with a bi-layered bromobutyl rubber and polyisoprene rubber flat disc containing 3 mL of solution.
Maltese: Skartoċċ (ħġieġ bla kulur tat-tip I) li fih 3 mL ta' soluzzjoni bi planġer (tal-lastku bromobutyl) u b'sigill ikkombinat tal-aluminju li fih ċirku ċatt b'żewg saffi wieħed tal-lastku bromobutyl u l-ieħor tal-lastku polyisoprene.
English: Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
Maltese: Studji in vitro jindikaw li l-affinità ta' insulin glargine u l-metaboliti tiegħu M1 u M2 għar-riċettur tal-insulina umana tixbah lil dik tal-insulina umana.
English: This pen works with most kinds and sizes of pen needles such as those manufactured by Becton, Dickinson & Company and Ypsomed.
Maltese: Din il-pinna taħdem mal-parti l-kbira tat-tipi u d-daqsijiet tal-labar talpinnen bħal dawk manifatturati minn Becton, Dickinson & Company u
English: A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Maltese: Sar studju bi grupp paralell li dam sejjer 24 ġimgħa fuq 125 tifel u tifla b'dijabete mellitus tat-tip 1 li kellhom minn sentejn sa 6 snin, fejn tqabblu insulin glargine mogħti darba kuljum filgħodu ma' insulina NPH mogħtija darba jew darbtejn kuljum bħala insulina tal-bażi.
English: A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Maltese: Sar ukoll studju crossover fejn ġew imqabbla insulin glargine flimkien ma' insulina lispro ma' NPH flimkien ma' insulina regolari umana (kull trattament ingħata għal 16-il ġimgħa f'ordni każwali) f'26 pazjent adolexxenti b'dijabete tat-tip I b'etajiet minn 12 sa 18-il sena.
English: Packs of 1, 5 and multipacks containing 10 (2 packs of 5) pens.
Maltese: Pakketti ta' 1, 5 u pakketti b'ħafna li fihom 10 (2 pakketti ta' 5) pinen.
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine group and a mean decrease of 0.8 kg in the standard care group.
Maltese: Waqt l-aħħar vista waqt it-trattament, kien hemm medja ta' żieda ta' 1.4 kg fil-piż tal-ġisem mil-linja bażi fil-grupp ta' insulin glargine u medja ta' tnaqqis ta' 0.8 kg fil-grupp ta' kura standard.
English: The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light.
Maltese: Il-prodott mediċinali jista' jinħażen għal massimu ta' 28 jum f'temperatura sa 30°C u 'l bogħod minn sħana diretta jew dawl dirett.
English: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Maltese: Trattament ta' dijabete mellitus fl-adulti, fl-adolexxenti u fit-tfal li għandhom età ta' sentejn u aktar.
English: Only use needles that are compatible for use with Nexvue (see “Nexvue Instructions for Use”).
Maltese: Uża biss labar li huma kompatibbli biex jintużaw ma' Nexvue (ara “Nexvue Istruzzjonijiet Dwar l-Użu”).
English: HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM versus 4.1 mM.
Maltese: NPH/regolari, bl-inqas livell jilħaq medja ta' 5.4 mM versus 4.1 mM.