FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Maltese: Fi provi kliniċi u esperjenza ta' wara l-bejgħ, kienu identifikati każi gravi aċċidentali jew intenzjonati ta' doża eċċessiva ta' aripiprazole waħdu f'pazjenti adulti bid-dożi rrapurtati kkalkulati sa 1,260 mg mingħajr ebda fatalità.
English: Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult patients who have shown an initial treatment response.
Maltese: Aripiprazole huwa effettiv li jżomm titjib kliniku waqt kura kontinwa f'pazjenti adulti li wrew rispons fil-bidu tal-kura.
English: Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the level prior to the initiation of the concomitant therapy.
Maltese: Mal-waqfien tal-impeditur ta' CYP2D6 jew CYP3A4, id-dożaġġ ta' aripiprazole għandu jiżdied għad-doża ta' qabel il-bidu tat-terapija konkomitanti.
English: In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
Maltese: F'żewġ provi ta' monoterapija kkontrollata bi plaċebo u attiva ta' 12-il ġimgħa f'pazjenti b'episodju manijaku jew imħallat ta' Disturb Bipolari I, bi jew mingħajr karatteristiċi psikotiċi, aripiprazole wera effikaċja superjuri għal plaċebo f'ġimgħa 3 u manteniment ta' effett komparabbli għal litju jew haloperidol f'ġimgħa 12.
English: • slower heartbeat,
Maltese: • taħbit tal-qalb aktar bil-mod,
English: • stomach discomfort,
Maltese: • diffikultà biex torqod,
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure, CGI-BP Severity of Illness score (mania).
Maltese: L-għoti ta' aripiprazole bħala mediċina addizzjonali aġġuntiv wera superjoritaà fuq ilplaċebo fuq il-kejl tar-riżultat sekondarju, il-punteġġ tas-Sseverità tal-Mmarda CGI-BP (manija).
English: Pathological gambling Impulse-control disorders Binge eating
Maltese: Logħob tal-ażżard u disturbi fil-kontroll tal-impuls
English: • muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Maltese: • ebusija tal-muskoli, u ħedla jew ngħas, tieħu n-nifs aktar bil-mod, tifga, pressjoni għolja jew baxxa, ritmi mhux normali tal-qalb.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena jew aktar: id-doża rakkomandata għal aripiprazole hi ta' 10 mg/kuljum li tingħata fuq skeda ta' darba kuljum mingħajr ma jingħata kas tal-ikel.
English: • muscle disorder causing twisting movements (dystonia),
Maltese: • disturb tal-muskoli li jikkawża movimenti ta' liwi (distonija),
English: In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Maltese: Fi provi kliniċi b'aripiprazole, ma kienx hemm differenzi sinifikanti fir-rati ta' inċidenza ta' reazzjonijiet avversi assoċjati ma' ipergliċemija (inkluż id-dijabete) jew fil-valuri tal-laboratorju ta' gliċemija annormali mqabbla ma' plaċebo.
English: Hyperglycaemia Hyponatremia Anorexia
Maltese: Sintomi ekstrapiramidali oħra
English: Aripiprazole Mylan Pharma 15 mg tablets are yellow, round and biconvex of 10.1 mm in diameter, engraved with ‘15' on one side.
Maltese: Pilloli Aripiprazole Mylan Pharma 15 mg huma sofor, tondi u bikonvessi ta 10.1 mm fid-dijametru, imnaqqxa bil “15” fuq naħa waħda.
English: When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
Maltese: Meta l-induttur ta' CYP3A4 ma jibqax jingħata ma' aripiprazole, id-doża ta' aripiprazole għandha titnaqqas sad-doża rakkomandata (ara sezzjoni 4.5).
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir)
Maltese: protease, eż. indinavir, ritonavir)
English: The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3 %) was similar to that of placebo (0.2 %).
Maltese: Il livelli ta' prolaktin kienu evalwati fil-provi kollha tad-dożi kollha ta' aripiprazole (n = 28,242). L inċidenza ta' iperprolaktinimija jew żieda ta' prolaktin fis-serum f'pazjenti trattati b'aripiprazole (0.3%) kienet simili għal dik tal plaċebo (0.2%).
English: • hiccups.
Maltese: • puplesija,
English: Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Maltese: Aripiprazole għandu jintuża b'kawtela f'pazjenti b'titwil tal-QT fl-istorja tal-familja (ara sezzjoni 4.8).
English: In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Maltese: Fi provi kliniċi, ġew irrappurtati xi każijiet rari ta' konvulżjoni waqt it-trattament b'aripiprazole.
English: Hiccups
Maltese: Maltosju
English: However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Maltese: Madankollu, f'waħda minn dawn il-provi, prova b'doża fissa, kien hemm konnessjoni sinifikanti ta' rispons għad-droga għal reazzjonijiet avversi ċerebrovaskulari f'pazjenti kkurati b'aripiprazole (ara sezzjoni 4.8).
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Mylan Pharma 10 mg tablets aripiprazole
Maltese: Aripiprazole Mylan Pharma 10 mg pilloli aripiprazole
English: • involuntary, irregular muscle movements, especially in the face
Maltese: • movimenti irregolari, involontarji tal-muskoli, b'mod speċjali fil-wiċċ
English: Hyperprolactinaemia Diabetic hyperosmolar coma Diabetic ketoacidosis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Maltese: Meta aripiprazole jingħata ma' impedituri qawwija ta' CYP3A4 jew CYP2D6, id-doża ta' aripiprazole għandha titnaqqas.
English: • St John's Wort (Hypericum perforatum) used as a herbal remedy for mild depression
Maltese: John's Wort (Hypericum perforatum) użat bħala rimedju magħmul mill-ħxejjex għal depressjoni ħafifa
English: The overall completion rate was significantly higher for patients on aripiprazole (43 %) than for haloperidol (30 %).
Maltese: Ir-rata globali ta' dawk li spiċċaw il-kors kienet sinifikament ogħla għallpazjenti fuq aripiprazole (43%) milli għall-haloperidol (30%).
English: Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established.
Maltese: Anomaliji konġenitali kienu rrappurtati; madankollu, relazzjoni kawżali ma' aripiprazole ma setgħetx tiġi stabbilita.
English: Agitation
Maltese: Suwiċidalità
English: There are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger adult subjects, nor is there any detectable effect of age in a population pharmacokinetic analysis in schizophrenic patients.
Maltese: M'hemm l-ebda differenza fil-farmakokinetiċi ta' aripiprazole bejn anzjani b'saħħithom u pazjenti adulti, lanqas ma hemm effett li għandhu x'jaqsam ma' l-età f'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti skizofreniċi.
English: In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Mylan Pharma.
Maltese: Fl-adulti, jipprevjeni wkoll din il-kundizzjoni milli terġa' tiġi lura f'pazjenti li jkunu rrispondew għat-trattament b'Aripiprazole Mylan Pharma.
English: In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Maltese: F'żewġ provi ta' monoterapija kkontrollata bi plaċebo, b'doża flessibbli ta' 3 ġimgħat li nvolvew pazjenti b'episodju manijaku jew imħallat ta' Disturb Bipolari I, aripiprazole wera effikaċja superjuri għal plaċebo fit-tnaqqis ta' sintomi manijaċi fuq 3 ġimgħat.
English: Fatigue
Maltese: Konvulżjoni
English: A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Maltese: Imblokkatur ta' l-aċidu fl-istonku, l-antagonista ta' l-H2 fomatidine, inaqqas ir-rata li biha jiġi assorbit aripiprazole, iżda dan l-effett m'huwiex meqjus bħala wieħed klinikament relevanti.
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for aripiprazole is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Maltese: Episodji manijaċi f'Disturb Bipolari I: id-doża rakkomandata tal-bidu għal aripiprazole hija 15 mg mogħtija fuq skeda ta' darba kuljum fuq stonku vojt jew fuq stonku mimli bħala monoterapija jew bħala terapija ta' kombinazzjoni (ara sezzjoni 5.1).
English: • unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: • movimenti mhux tas-soltu (speċjalment tal-wiċċ jew l-ilsien) u livell mnaqqas ta' koxjenza.
English: Additionally, aripiprazole and dehydroaripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Maltese: Ukoll, aripiprazole u dehydro-aripiprazole ma wrewx li jistgħu ibiddlu il-metaboliżmu li jiġi effettwat misCYP1A2 fi studji in vitro.
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Maltese: Każijiet ta' sindromu ta' serotonin ġew irrappurtati f'pazjenti li kienu qed jieħdu aripiprazole u sinjali u sintomi possibbli għal din il-kundizzjoni jistgħu jseħħu speċjalment f'każijiet ta' użu fl-istess ħin ma' mediċini serotonerġiċi oħrajn, bħal SSRI/SNRI, jew ma' mediċini li huma magħrufa li jżidu l-konċentrazzjonijiet ta' aripiprazole (ara sezzjoni 4.8).
English: Aripiprazole Mylan Pharma 10 mg tablets are pink, round and biconvex of 8.1 mm in diameter, engraved with ‘10' on one side.
Maltese: Pilloli Aripiprazole Mylan Pharma 10 mg huma roża, tondi u bikonvessi tal 8.1 mm fid-dijametru, imnaqqxa bil “10” fuq naħa waħda.
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Maltese: • reazzjoni allerġika (eż. nefħa fil-ħalq, ilsien, wiċċ u gerżuma, ħakk, urtikarja);
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Maltese: Disturb fir-regolazzjoni tat-temperatura (eż. ipotermija, deni) Uġigħ fis-sider Edema periferali
English: Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Maltese: Ħsibijiet u imġiba ta' suwiċidju ġew irrapportati matul trattament b'aripiprazole.
English: • thoughts of suicide, suicide attempt and suicide,
Maltese: • ħsibijiet ta' suwiċidju, tentattiv ta' suwiċidju, suwiċidju
English: Dysphagia
Maltese: Dispepsija
English: Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated with placebo.
Maltese: Il-medja tażżieda fil-piż fi 30 ġimgħa ta' intervall fit-trattament kienet ta' 2.9 kg meta mqabbla ma' 0.98 kg f'pazjenti kkurati bil-plaċebo.
English: The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Mylan Pharma tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Maltese: Is-sintomi li ġejjin jistgħu jseħħu fi trabi tat-twelid, ta' ommijiet li użaw Aripiprazole Mylan Pharma fl-aħħar trimestru (l-aħħar tliet xhur tat-tqala tagħhom): rogħda, għebusija u/jew dgħjufija tal-muskoli, ħedla, aġitazzjoni, problemi bit-teħid tan-nifs, u diffikultà biex jerdgħu.
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
Maltese: Madankollu, ir-rilevanza klinika ta' dan irriżultat ma ġietx stabbilita.
English: • indigestion,
Maltese: • indiġestjoni,
English: ATC Code: A10AE04.
Maltese: A10AE04.
English: MedDRA system organ classes
Maltese: Sistema talklassifika tal-organi MedDRA
English: Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.
Maltese: Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) L-Italja.
English: Glucose Utilization Rate* (mg/kg/min)
Maltese: (mg/kg/min)
English: KwikPen Multipack: 10 (2 packs of 5) pens of 3 mL.
Maltese: KwikPen Pakkett multiplu: 10 (2 pakketti ta' 5) pinen ta' 3 mL.
English: ------ NPH insulin
Maltese: ------ insulina NPH
English: • Labels:
Maltese: • Tikketti:
English: Store below 30 º C.
Maltese: Aħżen f'temperatura taħt 30°C.
English: KwikPen 5 pens of 3 mL.
Maltese: KwikPen 5 pinen ta'3 mL.
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE ABASAGLAR
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: <1/10,000).
Maltese: ≥1/10; komuni: ≥ 1/100 sa < 1/10; mhux komuni: ≥ 1/1,000 sa < 1/100; rari: ≥ 1/10,000 sa < 1/1,000;
English: ABASAGLAR with alcohol
Maltese: ABASAGLAR ma' alkoħol
English: Pack of 5
Maltese: Pakkett ta' 5
English: - The active substance is insulin glargine.
Maltese: - Is-sustanza attiva hi insulin glargine.
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 kontra l-ħin ta' insulin glargine u l-insulina NPH.
English: Clinical safety and efficacy
Maltese: Effikaċja klinika u sigurtà
English: Tel: +372 6 817 280
Maltese: Eesti Tel: +372 6 817 280
English: ABASAGLAR KwikPen (“Pen”) is a disposable pen containing 300 units (3 mL) of insulin glargine.
Maltese: ABASAGLAR KwikPen (“Pinna”) hija pinna li tintrema wara li tintuża u li fiha 300 unità (3 mL) ta' insulina glargine.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Disgewżja
English: Lilly France S.A.S.
Maltese: Lilly France SAS
English: * Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Maltese: * Insulin glargine huwa magħmul bit-teknoloġija rikombinanti tad-DNA ġo Escherichia coli.
English: • Store unused pens in the refrigerator at 2 ° C to 8 ° C.
Maltese: • Aħżen pinen mhux użati fil-friġġ f'temperatura bejn 2 ° C sa 8 ° C.
English: This is a modified insulin, very similar to human insulin.
Maltese: Dan huwa insulina mmodifikata, simili ħafna għall-insulina umana.
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France.
Maltese: Lilly France S.A.S., rue du Colonel Lilly, F-67640
English: • KwikPen compatible needle (BD [Becton, Dickinson and Company] pen needles recommended).
Maltese: • Labra li taqbel mal-KwikPen (huma rrakkomandati l-labar għall-pinen BD [Becton, Dickinson and Company]).
English: Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for injections
Maltese: Eċċipjenti: zinc oxide, metacresol, glycerol, hydrochloric acid u sodium hydroxide , ilma għallinjezzjonijiet
English: Participants were randomised (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 arbitrarju (1:1), biex jew jirċievu insulin glargine (n=6264), li ġie titrat biex jilħaq FPG ≤95 mg/dL (5.3 mM) jew kura standard (n=6273).
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32 % in the insulin glargine / lispro group vs. 52 % in the NPH / regular group.
Maltese: B'mod simili, l-inċidenza ta' ipogliċemija ta' matul il-lejl kienet ta' 32% fil-grupp ta' insulin glargine / lispro vs. 52% fil-grupp ta' insulina NPH / regolari.
English: Step 8:
Maltese: Pass 8:
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, L-Olanda.
English: KwikPen Parts
Maltese: KwikPen
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-valuri medjani ta' HbA1c waqt il-kura 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: Pack of 5 and 10
Maltese: Pakkett ta' 5 u 10
English: Packs of 5 and 10 cartridges.
Maltese: Pakketti ta' 5 u 10 skrataċ .
English: 2, rue du Colonel Lilly F-67640 Fegersheim France
Maltese: Lilly France S.A.S. 2, rue du Colonel Lilly F-67640
English: Packs of 5 pens and multipacks containing 10 (2 packs of 5) pens .
Maltese: Pakketti ta' 5 pinen u pakketti multipli li fihom 10 pinen (2 pakketti ta' 5 pinen) huma disponibbli.
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 tal glukożju.
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
Maltese: Insulin glargine hija analoga ta' insulina umana imfassla biex ikollha solubilità baxxa f'pH newtrali.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, 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, tat-tip 2x2 factorial, fejn il-parteċipanti ġew assenjati b'mod arbitrarju biex jirċievu l-mediċina, li sar fi 12,537 parteċipant b'riskju kardjovaskulari (CV - cardiovascular) għoli u b'indeboliment fil kontroll tal-glukożju fl-istat ta' sawm (IFG - impaired fasting glucose) jew b'indeboliment fittolleranza għall-glukożju (IGT - impaired glucose tolerance) (12% tal-parteċipanti) jew bid-dijabete mellitus tat-tip 2 ikkurata b' ≤1 sustanza antidijabetika orali (88% tal-parteċipanti).
English: ABASAGLAR 100 units/mL injection KwikPen insulin glargine
Maltese: ABASAGLAR 100 unità/mL, injezzjoni KwikPen insulin glargine
English: Step 1:
Maltese: Pass 1:
English: How to store ABASAGLAR Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: EU/1/14/944/007 EU/1/14/944/008 EU/1/14/944/012 EU/1/14/944/013
Maltese: EU/1/14/944/012 EU/1/14/944/013
English: PC: {number} SN: {number} NN: {number}
Maltese: Kif taħżen il-pinna tiegħek Pinen mhux użati
English: In use:
Maltese: Attenzjoni:
English: Figure 1: Activity profile in patients with type 1 diabetes
Maltese: Figura 1: Profil t'attività f'pazjenti bid-dijabete tat-tip 1
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: sa 8 darbiet aktar minn dik tal-insulina umana (iżda madwar 70 sa 80 darba inqas minn dik ta' IGF-1), filwaqt li l-affinità tar-rabta ta' M1 u M2 mar-riċettur IGF-1 huwa daqsxejn inqas meta mqabbel malinsulina umana.
English: For further details on handling, see section 6.6.
Maltese: Għal aktar dettalji dwar l-immaniġġar, ara sezzjoni 6.6.
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistgħux jinbigħu b'mod separat.
English: Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).
Maltese: Kull mL fih 100 unità ta' insulin glargine* (ekwivalenti għal 3.64 mg).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: • Pen colour:
Maltese: • Kulur tal-pinna:
English: ABASAGLAR contains insulin glargine.
Maltese: ABASAGLAR fih insulin glargine.
English: Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).
Maltese: Kull mL fih 100 unità insulin glargine (ekwivalenti għal 3.64 mg).
English: HYPOGLYCAEMIA (low blood sugar levels)
Maltese: IPOGLIĊEMIJA (livelli baxxi ta' zokkor fid-demm)
English: Step 9:
Maltese: Pass 9:
English: Each millilitre of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
Maltese: Kull millilitru ta' soluzzjoni fih 100 unità tas-sustanza attiva insulin glargine (ekwivalenti għal 3.64 mg).
English: EU/1/14/944/003 EU/1/14/944/009
Maltese: EU/1/14/944/009
English: Other medicines and ABASAGLAR
Maltese: Mediċini oħra u ABASAGLAR
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens, 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: phenothiazine , somatropin, prodotti mediċinali simpatomimetiċi (eż. epinephrine [adrenaline], salbutamol, terbutaline), ormoni tat-tirojde, prodotti mediċinali antipsikotiċi atipiċi (eż clozapine u olanzapine) u inibituri tal-protease.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: ABASAGLAR 100 units/mL injection insulin glargine
Maltese: ABASAGLAR 100 unità/mL, injezzjoni. insulin glargine
English: Marketing Authorisation Holder
Maltese: KONDIZZJONIJIET U REKWIŻITI
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 (21A-Gly-des-30B-Thr-insulin).
English: Date of first authorisation: 9 September 2014 Date of latest renewal: 25 July 2019
Maltese: Data tal-aħħar tiġdid: 25 Lulju 2019
English: Label
Maltese: LISTA
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 ta' sentejn sa inqas minn 6 snin b'dijabete mellitus tat-tip 1 kienet evalwata fi studju kliniku wieħed (ara sezzjoni 5.1).
English: Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Maltese: Insulin glargine ma biddilx ir-riskju relattiv għal mard kardjovaskulari u mortalità kardjovaskulari meta mqabbel ma' kura standard.