FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid and water for injections.
Maltese: - Is-sustanzi l-oħra huma: zinc oxide, metacresol, glycerol, sodium hydroxide, (ara sezzjoni 2 “Tagħrif importanti dwar xi wħud mis-sustanzi ta'ABASAGLAR” ), hydrochloric acid u ilma għall-injezzjonijiet.
English: Problems with the insulin pen?
Maltese: Problemi bil-pinna tal-insulina?
English: - If you do not see insulin, repeat the priming steps, but not more than 4 times.
Maltese: - Jekk inti ma tarax insulina, irrepeti l passi tal-ikkargar, iżda għal mhux aktar minn 4 darbiet.
English: EXP
Maltese: NPH
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 anologues and sulphonamide antibiotics.
Maltese: Sustanzi li jistgħu jżidu l-effett tat-tnaqqis fil-livell tal-glukożju fid-demm, u jżidu r-riskju għalliżvilupp ta' l-ipogliċemija, jinkludu prodotti mediċinali orali kontra d-dijabete, inibituri tal-enzima li tikkonverti angiotensin (ACE), disopyramide, fibrati, fluoxetine, inibituri ta' monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates, analogi ta' somastostatin u l-antibijotiċi sulphonamide.
English: Step 10:
Maltese: Pass 10:
English: Step 14:
Maltese: Pass 14:
English: Switch from insulin glargine 300 units/ml to ABASAGLAR ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Maltese: ABASAGLAR u Toujeo (insulina glargine 300 unità/ml) mhumiex bijoekwivalenti u ma jistgħux jinbidlu ma xulxin b'mod dirett.
English: 3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal (laminate of polyisoprene and halobutyl rubber) with aluminium seal.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 3 mL soluzzjoni fi skartoċċ (ħġieġ tat-tip 1 mingħajr kulur) bi planġer (lastku halobutyl) u b'siġill f'forma ta' disk (saffi ta' lastku polyisoprene u halobutyl) b'siġill tal-aluminju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON of a multipack (without blue box) - KwikPen
Maltese: KARTUNA TAN-NOFS ta' pakkett multiplu (mingħajr il-kaxxa blu) - KwikPen
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
English: Insulin pen
Maltese: Insulin glargine
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 inkroċjat fejn ġew imqabbla insulin glargine flimkien ma' lispro insulin u NPH flimkien ma' insulina umana regolari (kull kura ngħatat għal 16-il ġimgħaf'ordni każwali) f'26 pazjent adolexxent dijabetiku tat-tip I b'etajiet minn 12 sa 18-il sena.
English: Dose Knob
Maltese: Buttuna tad
English: 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 tal-insulin glargine u l-metaboliti tiegħu M1 u M2 għar-riċettur talinsulina umana hija simili għal dik tal-insulina umana.
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 ta' grupp parallel li dam sejjer 24 ġimgħa fuq 125 tifel u tifla b'dijabete mellitus tat-tip 1 li kellhom minn sentejn sa 6 snin, li qabbel l-insulina glargine mogħtija darba kuljum filgħodu ma insulina NPH mogħtija darba jew darbtejn kuljum bħala insulina tal-bażi.
English: ABASAGLAR is a biosimilar medicinal product.
Maltese: ABASAGLAR hu prodott mediċinali bijosimili.
English: - beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
Maltese: - imblokkaturi tar-riċetturi beta (użati għall-kura ta' pressjoni għolja), - clonidine (użat għall-kura ta' pressjoni għolja), - is-sustanzi tal-lithium (użati għall-kura ta' disturbi psikjatriċi).
English: Only use needles that are compatible for use with ABASAGLAR KwikPen (see “ABASAGLAR KwikPen Instructions for Use”).
Maltese: Uża biss labar li huma kompatibbli għall użu ma' ABASAGLAR KwikPen (ara “L-Istruzzjonijiet dwar l-Użu ta' ABASAGLAR KwikPen”).
English: Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Maltese: L-effetti ta' insulin glargine (darba kuljum) fuq retinopatija tad-dijabete ġew evalwati f'1,024 pazjent dijabetiku tat-tip 2 fi studju ta' ħames snin, fejn kemm l-investigatur kif ukoll il-pazjenti kienu jafu x'mediċini kienu qed jintużaw, b'NPH bħala kontroll (NPH ingħata darbtejn kuljum) fejn il-progress tar-retinopatija bi tlett gradi jew aktar fuq l-iskala tal-iStudju Dwar Kura Bikrija ta' Retinopatija tadDijabete (ETDRS - Early Treatment Diabetic Retinopathy Study) kien investigat b'ritratt tal-fundus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for multipack (with blue box) - KwikPen
Maltese: KARTUNA TA' BARRA għall-pakkett multiplu (bil-kaxxa blu) - KwikPen
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e , tista' tgħid li huwa “ħieles mis-sodium”.
English: Retinopathy
Maltese: Retinopatija
English: Renal impairment
Maltese: Reazzjonijiet allerġiċi
English: In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation.
Maltese: F'ħafna pazjenti, is-sinjali u s-sintomi ta' newroglikopenija jseħħu wara sinjali ta' kontroregolazzjoni adrenerġika.
English: Rubber Seal
Maltese: Siġill tal-Lastku
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Maltese: Eżempji ta' sintomi li jindikaw livell baxx taz-zokkor fil-moħħ: uġigħ ta' ras, ġuħ kbir, dardir, rimettar, għeja, ngħas, disturbi fl-irqad, nuqqas ta' kwiet, komportament aggressiv, telf ta' konċentrazzjoni, reazzjonijiet indeboliti, depressjoni, konfużjoni, disturbi fid-diskors, (xi drabi it-telf komplet tad-diskors), indeboliment tal-vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim madwar il-ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t-telf mis-sensi.
English: Each pen contains 3 mL of solution for injection, equivalent to 300 units.
Maltese: Kull pinna fiha 3 mL ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 300 unità.
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Maltese: M1 u M2 (ara sezzjoni 5.2).
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: Elderly population (≥65 years old)
Maltese: Popolazzjoni anzjana (≥ 65 sena)
English: How to use ABASAGLAR
Maltese: Tużax ABASAGLAR
English: No data are available.
Maltese: - Taqlax it-tikketta tal-pinna.
English: EU/1/14/944/003 5 cartridges EU/1/14/944/009 10 cartridges
Maltese: EU/1/14/944/009 10 skrataċ
English: Step 13:
Maltese: Pass 13:
English: Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 300 units/mL), these medicines are not interchangeable.
Maltese: Għalkemm ABASAGLAR fih l-istess sustanza attiva bħal Toujeo (insulina glargine 300 unità/mL), dawn il-mediċini ma jistgħux jinbidlu ma xulxin.
English: - 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: - l-kortikosterojdi (bħal "cortisone", użat għall-kura tal-infjammazzjoni), - danazol (mediċina li taħdem fuq l-ovulazzjoni), - diazoxide (użat għall-kura ta' pressjoni għolja), - id-dijuretiċi (użati għall-kura ta' pressjoni għolja jew iż-żamma eċċessiva ta' fluwidi), - glukagon (ormon tal-frixa użat għall-kura ta' ipogliċemija severa), - isoniazid (użat għall-kura tat-tuberkulożi), - l-estroġeni u l-proġestoġeni (bħal fil-pillola kontraċettiva, użata għall-kontroll tat-tqala), - id-derivattivi ta' phenothiazine (użati għall-kura ta' disturbi psikjatriċi),
English: Over the course of this 6-year study, 42% of the insulin glargine group did not experience any hypoglycaemia.
Maltese: Matul il-kors kollu ta' dan l-istudju li dam 6 snin, 42% tal-grupp ta' insulin glargine ma kellhom ebda ipogliċemija.
English: • Wipe the rubber seal with a swab.
Maltese: • Aqla' l-protezzjoni ta' barra tal-labra.
English: • You can give from 1 to 6080 units in a single injection.
Maltese: • Tista' tagħti minn unità waħda sa 60 80 unità f'injezzjoni waħda.
English: Posology
Maltese: Tikketta
English: - If you see “0” in the dose window, you have received the full amount you dialled.
Maltese: - Jekk ma tarax “0” fit-tieqa tad-doża, terġax tisselezzjona mill-ġdid.
English: Insulin Mix-ups
Maltese: Tiddilwihx.
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Maltese: Meta mogħti minn ġol-vini, il-half-life ta' eliminazzjoni ta' insulin glargine u tal-insulina umana kienu simili.
English: In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Maltese: Fi studju kliniku, is-sintomi tal-ipogliċemija jew ir-risponsi ormonali kontro-regolatorji kienu simili wara insulin glargine u insulina umana mogħtijin mill-vina, kemm f'voluntiera f'saħħithom kif ukoll f'pazjenti bid-dijabete tip 1.
English: EU/1/14/944/007 5 pens EU/1/14/944/012 5 pens
Maltese: EU/1/14/944/012 5 pinen
English: Cap Clip
Maltese: Korp talPinna
English: Each cartridge contains 3 mL of solution for injection, equivalent to 300 units.
Maltese: Kull skartoċċ fih 3 mL ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 300 unità.
English: Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating.
Maltese: Reazzjonijiet allerġiċi qawwija (rari,jista' jaffettwa sa persuna 1 minn kull 1,000) - is-sinjali jistgħu jinkludu reazzjonijiet tal-ġilda fuq skala kbira (raxx u ħakk mal-ġisem kollu), nefħa severa fil-ġilda jew fil-membrani mukużi (anġioedima), qtugħ ta' nifs, , taqa' l-pressjoni fid-demm bil-polz mgħaġġel u tkun għarqan.
English: • It is normal to see a small amount of insulin left in the pen that you cannot inject.
Maltese: • Huwa normali li tara ammont żgħir ta' insulina li baqgħet fil-pinna li ma tistax tiġi injettata.
English: Each cartridge contains 3 mL of solution for injection (equivalent to 300 units) and they are available in packs of 5 and 10 cartridges.
Maltese: Kull skartoċċ fih 3 mL ta' soluzzjoni għall-injezzjoni (ekwivalenti għal 300 unità) u huma disponibbli f'pakketti ta' 5 u 10 skrataċ.
English: • Check the number in the dose window
Maltese: • Iċċekkja n-numru fit-tieqa tad-doża
English: • Dose Knob:
Maltese: Qabel l-użu:
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Maltese: Il-konċentrazzjoni terapewtika kollha tal-insulina (insulin glargine u l-metaboliti tiegħu) li nstabet f'pazjenti dijabetiċi tat-tip 1 kienet ħafna inqas milli hemm bżonn sabiex tintlaħaq nofs l-okkupazzjoni massima tar-riċettur IGF-1 u l-attivazzjoni sussegwenti tas-sensiela ta' reazzjonijiet mitoġeniċi proliferattivi mibdija mir-riċettur IGF-1.
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Maltese: L-insulina tinibixxi l-lipoliżi fl-adipoċita, tinibixxi l-proteoliżi u ttejjeb is-sinteżi tal-proteini.
English: Visual impairment
Maltese: Immaniġġar
English: In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
Maltese: Fi studji kliniċi, ġew osservati antikorpi li jirreaġixxu kemm mal-insulina umana u kemm mal-insulin glargine u dawn seħħew bl-istess frekwenza fiż-żewġ gruppi ta' trattament ta' NPH-insulin u insulin glargine.
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: rari ħafna: < 1/10,000).
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Maltese: Immedjatament ħu madwar 10 sa 20 g zokkor, bħal glukosju, dadi taz-zokkor jew xi xarba li jkun fiha ħafna zokkor.
English: Light grey with green colour bars
Maltese: Protezzjoni ta' Barra tal-Labra
English: • Eye reactions
Maltese: • Disturbi ġenerali
English: Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.
Maltese: Insulin glargine injettata darba kuljum tilħaq livelli fissi u stabbli fi żmien 2 - 4 ijiem wara l-ewwel doża.
English: - A drop of insulin at the needle tip is normal.
Maltese: - Qatra insulina fit-tarf tal-labra hija normali.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI)
English: • Swab
Maltese: Tfal
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel:
English: EU/1/14/944/008 5 pens EU/1/14/944/013 5 pens
Maltese: EU/1/14/944/013 5 pinen
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Maltese: Episodji ħfief ta' ipogliċemija jistgħu normalment ikunu trattati bil-karboidrati mill-ħalq.
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 viżta ta' matul il-kura, kien hemm medja ta' żieda fil-piż tal-ġisem ta' 1.4 kg mil-linja bażi fil-grupp ta' insulin glargine u medja ta' tnaqqis ta' 0.8 kg fil-grupp ta' kura standard.
English: Plasma trough levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Maltese: L-aktar livelli baxxi tal-insulin glargine fil-plasma u l-metaboliti prinċipali M1 u M2 tiegħu tkejlu fi tfal ikkurati b'insulin glargine li werew mudelli ta' konċentrazzjonijiet fil-plażma simili bħall-adulti u ma taw l-ebda evidenza ta' akkumulazzjoni ta'
English: Lipoatrophy
Maltese: Skartoċċ
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Maltese: Mediċini użati fid-dijabete, insulini u analogi għall-injezzjoni, jaħdmu fit-tul.
English: To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.
Maltese: Sabiex jitnaqqas ir-riskju ta' ipogliċemija, il-pazjenti li qed ibidlu l iskeda ta' insulina bażali minn skeda ta' insulina b'insulina glargine 300 unità/ml darba kuljum għal skeda ta' darba kuljum b'ABASAGLAR għandhom inaqsu d-doża tagħhom b'madwar 20%.
English: There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of insulin glargine.
Maltese: M'hemmx differenzi klinikament rilevanti fil-livelli tal-insulina jew tal-glukożju fis-serum wara li insulin glargine jingħata fiż-żaqq, fil-muskolu deltojd, jew fil-koxxa.
English: (Example: 25 units shown in the dose window)
Maltese: (Eżempju: qed jintwerew 25 unità fit-tieqa taddoża)
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Maltese: Fl-anzjani, id-deterjorament progressiv fil-funzjoni tal-kliewi jista' jwassal għal tnaqqis kostanti fil ħtiġijiet tal-insulina.
English: It is completely soluble at the acidic pH of the ABASAGLAR injection solution (pH 4).
Maltese: Hi tinħall għal kollox fil-pH aċiduża tas-soluzzjoni għall-injezzjoni ta' ABASAGLAR (pH 4).
English: ABASAGLAR is available in packs containing 5 pre-filled pens and in multipacks comprising 2 cartons, each containing 5 pre-filled pens.
Maltese: ABASAGLAR huwa disponibbli f'pakketti li fihom 5 pinen mimlijin għal-lest u f'pakketti multipli li fihom 2 kartun, kull waħda fiha 5 pinen mimlijin għal-lest.
English: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure),
Maltese: - l-inibituri ta' monoamine oxidase (MAO) (użati għall-kura tad-depressjoni),
English: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups.
Maltese: Varjabilitajiet ta' glikoemoglobina u glukożju kienu komparabbli fiżżewġ gruppi ta' kura.
English: Warning symptoms of hyperglycaemia
Maltese: Zinc oxide Metacresol Glycerol
English: Medication errors
Maltese: TAL-PRODOTT MEDIĊINALI
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Maltese: Tibdil fil-qawwa, fil-marka (il-manifattur), fit-tip (regolari, NPH, lente, effett fit-tul eċċ.), fl-oriġini (annimal, uman, insulina analoga umana) u/jew fil-metodu ta' manifattura jista' jirriżulta fil-ħtieġa ta' tibdil tad-doża.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/ Mekkaniżmu ta' azzjoni
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: F'każijiet rari, filpreżenza ta' antikorpi għall-insulina bħal dawn jista` jkun hemm bżonn ta` aġġustament fid-doża talinsulina biex tikkorreġi t-tendenza għall-iperġilċemija jew l-ipogliċemija (ara sezzjoni 5.1).
English: The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Maltese: Ir-rapporti dwar reazzjonijiet avversi li oriġinaw mis-sorveljanza ta' wara t-tqegħid fis-suq kienu jinkludu reazzjonijiet fis-sit tal-injezzjoni relattivament aktar spissi (uġigħ fis-sit tal-injezzjoni, reazzjoni fis-sit tal-injezzjoni) u reazzjonijiet fil-ġilda (raxx, urtikarja) fit-tfal u fl-adolexxenti (≤ 18-il sena) meta mqabblin mal-adulti.
English: Medicinal product subject to medical prescription
Maltese: IL-PRODOTT MEDIĊINALI
English: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone), - sulphonamide antibiotics.
Maltese: - pentoxifylline, propoxyphene, salicylates (bħall-aspirina, użati biex ittaffu l-uġigħ u jniżżlu d deni) - analogi ta' somatostatin (bħal octreotide, użat fil-kura ta' kondizzjoni li mhijiex komuni fejn inti tipproduċi ormon tat-tkabbir żejjed), - l-antibijotiċi sulphonamide.
English: The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin glargine is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of insulin glargine.
Maltese: Fil-parti l-kbira tal-individwi, insulin glargine u l-metabolit M2 ma nstabux u meta nstabu, il-konċentrazzjoni tagħhom kienet indipendenti mid-doża ta' insulin glargine li ngħatat.
English: (Example: 12 units shown in the dose window)
Maltese: (Eżempju: qed jintwerew 12-il unità fit-tieqa taddoża)
English: Giving your injection
Maltese: Protezzjoni ta'
English: Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily.
Maltese: Insulina glargine ġiet mogħtija darba kuljum fil-ħin tal-irqad u insulina umana NPH ġiet mogħtija darba jew darbtejn kuljum.
English: Combination of ABASAGLAR with pioglitazone
Maltese: Rata* tal-Użu tal-Glukożju
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - KwikPen.
Maltese: KARTUNA TA' BARRA - KwikPen.
English: Before use:
Maltese: NN: