FrancophonIA/ELRC3.0 huggingface dataset:
English: Taxotere is used with cisplatin and fluorouracil.
Maltese: Taxotere jintuża ma' cisplatin u fluorouracil.
English: Taxotere contains the active substance docetaxel.
Maltese: Taxotere fih is-sustanza attiva doċetaksel.
English: Taxotere is used with cisplatin and fluorouracil (other cancer medicines);
Maltese: Taxotere jintuża ma' cisplatin u fluorouracil (mediċini oħra kontra l-kanċer);
English: The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness).
Maltese: L-effetti sekondarji l-aktar komuni b'Taxotere (li dehru f'aktar minn pazjent wieħed f'kull 10) huma newtropenija (livelli baxxi ta' newtrofili, ċelloli bojod tad-demm li jiġġieldu l-infezzjoni), anemija (għadd baxx ta' ċelloli ħomor tad-demm), stomatite (infjammazzjoni tal-kisja tal-ħalq), dijarea, nawżja (tħossok imdardar), rimettar, alopeċja (telf tax-xagħar) u astenija (dgħjufija).
English: What are the risks associated with Taxotere?
Maltese: X'inhuma r-riskji assoċjati ma' Taxotere?
English: Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer).
Maltese: Taxotere jintuża ma' prednizone jew prednisolone (mediċini antiinfjammatorji) meta l-kanċer ma jkunx jista' jiġi kkurat permezz ta' tnaqqis kbir fil-produzzjoni ta' testosteron mill-ġisem (kanċer tal-prostata reżistenti għall-kastrazzjoni).
English: As for all medicines, data on the use of Taxotere are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Taxotere hija ssorveljata kontinwament.
English: Taxotere (docetaxel)
Maltese: Kif jintuża Taxotere?
English: In most of these studies, Taxotere was combined with other cancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments.
Maltese: F'ħafna minn dawn l-istudji, Taxotere ġie kkombinat ma' kuri oħra kontra l-kanċer u tqabbel jew mal-mediċini li jintuża f'kombinazzjoni magħhom, jew ma' kombinazzjoni ta' kuri differenti.
English: What measures are being taken to ensure the safe and effective use of Taxotere?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Taxotere?
English: Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver.
Maltese: Taxotere m'għandux jintuża f'pazjenti li għandhom għadd ta' newtrofili li huwa inqas minn 1,500 ċellola/mm3 jew li għandhom mard gravi fil-fwied.
English: It can also be used with androgen-deprivation therapy when hormonal treatment still works (hormone-sensitive prostate cancer);
Maltese: Jista' jintuża wkoll ma' terapija ta' deprivazzjoni tal-androġenu meta l-kura ormonali tkun għadha taħdem (kanċer tal-prostata sensittiv għall-ormoni).
English: An overview of Taxotere and why it is authorised in the EU
Maltese: Reproduction is authorised provided the source is acknowledged
English: How is Taxotere used?
Maltese: Kif jaħdem Taxotere?
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll ma' mediċini oħra kontra l-kanċer (doxorubicin, cyclophosphamide, trastuzumab jew capecitabine) fuq pazjenti li jkunu għadhom ma ngħataw l-ebda kura għall-kanċer tagħhom jew wara li kuri oħrajn ma jkunux ħadmu, skont it-tip u l-istadju tal-kanċer tas-sider li jkun qed jiġi kkurat;
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet, ara lfuljett ta' tagħrif.
English: The active substance in Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Maltese: Is-sustanza attiva f'Taxotere, id-doċetaksel, tagħmel parti mill-grupp ta' mediċini kontra l-kanċer magħrufa bħala tassani.
English: Side effects reported with Taxotere are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Taxotere huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What benefits of Taxotere have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Taxotere li ħarġu mill-istudji?
English: 90 (3x30) tablets (multipack)
Maltese: 90 (3x30) pillola (pakkett multiplu)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1068/001 Wakix
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata Il-pakkett li jmiss malprodott
English: Radiopharmaceutical precursor, solution vial (glass) 1 to 3 ml
Maltese: Prekursur radjufarmaċewtiku, soluzzjoni kunjett (talħġieġ)
English: Protect your SoloStar from dust and dirt.
Maltese: Il-qawwa ta' dan il-prodott huwa stmat f'unitajiet.
English: Date of latest renewal: 20 August 2009
Maltese: Data tal-aħħar tiġdid: 20 ta' Awissu 2009
English: ATC code: A10AB06
Maltese: A10AB06
English: Figure 1A
Maltese: Figura 1A
English: Figure 1B
Maltese: Figura 1B
English: Sodium chloride Trometamol
Maltese: Sodium chloride
English: - The active substance is insulin glulisine.
Maltese: - Is-sustanza attiva hi insulina glulisine.
English: See section 4.
Maltese: Ara Sezzjoni 4.
English: Insulin glulisine
Maltese: Insulina glulisine
English: The average body mass index (BMI) of patients was 34.55 kg/m2.
Maltese: (BMI) tal-pazjenti kien ta' 34.55 kg/m2.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/
English: The glucose excursion (AUC 0-6h) was 641 mg.h.dl-1 for insulin glulisine and 801 mg.h.dl-1 for regular human insulin.
Maltese: Il ħarġa tal-glukosju (AUC 0-6h) kien ta' 641 mg.h.dl-1 għall-insulina glulisine u 801 mg.h.dl-1 għallinsulina regolari umana.
English: Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
Maltese: Tel: 800 13 12 12 (domande di tipo tecnico)
English: Important information for use of SoloStar:
Maltese: Informazzjoni importanti għall-użu ta' SoloStar:
English: Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Maltese: +32 (0)2 710 54 00 (Belgique/Belgien) Magyarország
English: 2 years.
Maltese: 15-il minuta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Settembru 2004
English: − ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Apidra in 1 unit dose increments.
Maltese: − ClikSTAR, Tactipen, Autopen 24, AllStar u AllStar PRO li kollha jfornu Apidra b'żidiet fid-doża ta' unità 1.
English: − JuniorSTAR which delivers Apidra in 0.5 unit dose increments
Maltese: − JuniorSTAR li tforni Apidra b'żidiet fid-doża ta' 0.5 unitajiet
English: Apidra contains metacresol
Maltese: Apidra fih metacresol
English: Step 3 Perform a safety test
Maltese: Pass Nru. 3 Agħmel test ta' sigurtà
English: Injection site reactions Local hypersensitivity reactions
Maltese: Reazzjonijiet fil-post ta' linjezzjoni u reazzjonijiet lokali ta' sensittività eċċessiva
English: Dose proportionality
Maltese: Proporzjonalità tad-doża
English: Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Maltese: Mit-tagħrif empiriku dwar prodotti mediċinali simili, interazzjonijiet farmakokinetiċi klinikament rilevanti mhux probabbli li jiġru.
English: D-65926 Frankfurt am Main, Germany
Maltese: D-65926 Frankfurt am Main
English: In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427 mg/kg for insulin glulisine, 121 minutes and 354 mg/kg for lispro, 150 minutes and 197 mg/kg for regular human insulin (see figure 2).
Maltese: kienu, rispettivament, 114-il minuta u 427 mg/kg/ għall-insulina glulisine, 121 minuta u 354 mg/kg/ għall-lispro, 150 minuta and 197 mg/kg għall-insulina regolari umana (ara figura 2).
English: Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Maltese: L-insulina glulisine hija magħmula bit-teknoloġija rikombinanti tad-DNA f'Escherichia coli.
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable between 15°C and 25°C for 48 hours (see section 6.6).
Maltese: Insulin glulisine għall-użu minn ġol-vini f'konċentrazzjoni ta' Unità 1/ml, f'temperatura bejn 15°C u 25°C, huwa stabbli għal 48 siegħa (ara sezzjoni 6.6).
English: Insulin glulisine given 2 minutes (GLULISINE pre) before the start of a meal compared to regular human insulin given 30 minutes (REGULAR 30 min) before the start of the meal (figure 1A) and compared to regular human insulin given 2 minutes (REGULAR pre) before a meal (figure 1B).
Maltese: L-insulina glulisine, mogħtija 2 minuti (GLULISINE pre) qabel ilbidu ta' ikla mqabbla ma' insulina regolari umana mogħtija 30 minuta (REGULAR 30 min) qabel ilbidu ta' l-ikla (figura 1A), u mqabbla ma' l-insulina regolari umana mogħtija 2 minuti (REGULAR pre) qabel l-ikla (figura 1B).
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen EU/1/04/285/029-036
Maltese: Apidra SoloStar 100 Unità/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/04/285/029-036
English: The Apidra cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Maltese: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO jew JuniorSTAR (ara sessjonijiet 4.2 u 4.4).
English: Organ system classes
Maltese: Sistema talKlassifika talOrgani fidDatabase
English: Systemic hypersensitivity reactions
Maltese: sensittività eċċessiva
English: Packs of 1, 2, 4 and 5 vials are available.
Maltese: Pakketti ta' 1, 2, 4 u 5 kunjetti huma disponibbli.
English: • Metabolism and nutrition disorders
Maltese: • Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Maltese: Id-data farmakokinetika disponibbli hija limitata f'pazjenti anzjani bid-dijabete mellitus.
English: Apidra should be used at a concentration of 1 Unit/ml insulin glulisine in infusion systems with sodium chloride 9 mg/ml (0.9%) solution for infusion with or without 40 mmol/l potassium chloride using coextruded polyolefin/polyamide plastic infusion bags with a dedicated infusion line.
Maltese: Apidra għandu jintuża f'konċentrazzjoni ta' unità 1/ml ta' insulin glulisine f'sistemi ta' infużjoni b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9 %) li jista' jkollu jew ma jkollux 40 mmol/l ta' potassium chloride u fejn jintużaw boroż tal-infużjoni tal-plastik magħmula millestrużjoni flimkien ta' polyolefin/polyamide b'linja ta' infużjoni għal tal-apposta.
English: 5 vials of 10ml.
Maltese: 5 kunjetti ta' 10 ml
English: The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11% CV).
Maltese: Il-bijodisponibilità assoluta (70%) ta' l-insulina glulisine kienet l-istess fis-siti ta' linjezzjoni u kellha varjabilità baxxa fl-istess individwi (11%CV).
English: The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure 3).
Maltese: Il-ħin medju kemm iddum l-insulina glulisine kien iqsar (98 minuta) minn dak ta' linsulina regolari umana (161 minuta) (ara figura 3).
English: INFORMATION IN BRAILLE Apidra
Maltese: INFORMAZZJONI BIL-BRAILLE
English: INFORMATION IN BRAILLE Apidra SoloStar
Maltese: Apidra SoloStar
English: In a study in patients with type 1 diabetes mellitus after subcutaneous administration of 0.15 Units/kg, for insulin glulisine the Tmax was 55 minutes and Cmax was 82 ± 1.3 µUnits/ml compared to a Tmax of 82 minutes and a Cmax of 46 ± 1.3 µUnits/ml for regular human insulin.
Maltese: Unitajiet/kg, it-Tmax kien ta' 55 minuta u ċ-Cmax kien 82 ± 1.3 µUnitajiet/ml għall-insulina glulisine, fil-waqt li t-Tmax kien ta' 82 minuta u ċ-Cmax kien 46 ± 1.3 µUnitajiet/ml għall-insulina regolari umana.
English: Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Maltese: Sustanzi li jistgħu jżidu l-attività biex jonqos il-livell tal-glukosju fid-demm u jżidu s-suxxettibilità għall-ipogliċemija jinkludu prodotti mediċinali orali antidijabetiċi, inibituri ta' l-enzima li tikkonverti angiotensin(ACE), disopyramide, fibrates, fluoxetine, inibituri ta' monamine oxidase (MAOIs), pentoxifylline, propoxyphene, salicylates u l-antibijotiċi sulphonamides.
English: In a clinical study performed in non-diabetic subjects covering a wide range of renal function (CrCl >80 ml/min, 30-50 ml/min, <30 ml/min), the rapid-acting properties of insulin glulisine were generally maintained.
Maltese: Fi studju kliniku magħmul fuq individwi mhux dijabetiċi, li mess firxa wiesa' ta' livell tal-funzjoni renali (CrCl >80 ml/min, 30-50 ml/min, < 30 ml/min), il-karatteristiċi ta' l-insulina glulisine li taħdem malajr ġeneralment inżammu.
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Maltese: Tel: +372 627 34 88 Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
English: Each vial contains 10 ml solution (1000 Units).
Maltese: Kull kunjett fih soluzzjoni ta'10 ml (1000 Unità).
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Metacresol
English: Obesity
Maltese: Fertilità
English: Apidra with alcohol
Maltese: Apidra ma' alkoħol
English: After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes.
Maltese: Wara li l-insulina tingħata taħt il-ġilda, l-insulina glulisine titneħħa aktar malajr mill-insulina regolari umana, b'half-life apparenti ta' 42 minuta meta mqabbla ma' 86 minuta.
English: In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption.
Maltese: B3 b'lysine, u l-lysine f'pożizzjoni B29 sostitut bl-aċidu glutamiku, jiffavorixxu l-assorbiment aktar mgħaġġel.
English: Insulin glulisine shows low plasma protein binding, similar to human insulin.
Maltese: L-insulina glulisine turi qabda baxxa mal-proteini tal-plażma, simili għall-insulina umana.
English: The time to 10% of total INS exposure was reached earlier by approximately 5-6 min with insulin glulisine.
Maltese: Il-ħin ta' 10% ta' l-espożizzjoni totali ta' l-INS intleħaq aktar kmieni b'madwar 5-6 minuti bl-insulina glulisine.
English: Step 2.
Maltese: Figura 2:
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available.
Maltese: Pakketti ta' 1, 3, 4, 5, 6, 8, 9 u 10 pinen huma disponibbli.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Germany
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Il-Ġermanja
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Sanofi-Aventis Deutschland GmbH
English: How to handle an infusion pump system
Maltese: Kif timmaniġġa sistema ta' infużjoni bil-pompa
English: Race and gender
Maltese: Razza u sess
English: Store in a refrigerator (2°C - -8°C).
Maltese: Aħżen fi friġġ (2°Ċ - 8°Ċ).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Maltese: U KWANTITATTIVA Kull ml fih 100 Unità ta' insulina glulisine (ekwivalenti għal 3.49 mg).
English: Figure 3: Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 Units/kg.
Maltese: Figura 3: Il-profili farmakokinetiċi ta' l-insulina glulisine u l-insulina regolari umana f'pazjenti biddijabete mellitus tat-tip I, wara doża ta' 0.15
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Maltese: Pakketti ta' 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi huma disponibbli.
English: The Apidra cartridges are to be used only with the pens: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.
Maltese: 24, AllStar, AllStar PRO, JuniorSTAR .
English: 8 pens of 3 ml.
Maltese: 8 pinen ta' 3 ml
English: Also contains: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections (see leaflet for further information).
Maltese: Għandu ukoll: metacresol, sodium chloride, trometamol, polysorbate 20, hydrochloric acid ikkonċentrat, sodium hydroxide, ilma għall-injezzjonijiet (ara l-fuljett għal aktar informazzjoni).
English: The following related adverse reactions from clinical studies were listed below 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), not known (cannot be estimated from the available data).
Maltese: Mill-istudji kliniċi, ir-reazzjonijiet avversi, li huma relatati li ġejjin huma mniżżla hawn isfel skont issistema tal-klassifika ta' l-organi u fl-ordni ta' frekwenza dejjem tonqos (komuni ħafna: ≥1/10; komuni: ≥1/100 sa <1/10; mhux komuni: ≥1/1,000 sa <1/100; rari:
English: The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration is similar with volumes of distribution of 13 l and 22 l and half-lives of 13 and 18 minutes, respectively.
Maltese: Id-distribuzzjoni u t-tneħħija ta' l-insulina glulisine u l-insulina regolari umana, wara li jingħataw ġol vina, huma l-istess, b'volum ta' distribuzzjoni ta' 13 l u 22 l u half-life ta' 13 u 18-il minuta, rispettivament.
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 and loss of consciousness.
Maltese: remettar, għeja, ngħas, disturbi fl-irqad, nuqqas ta' kwiet, mġieba aggressiva, nuqqas ta' konċentrazzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid-diskors, (xi drabi it-telf komplet tad-diskors), indeboliment tal-vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir-reġjun tal-ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t-telf mis-sensi.
English: Absorption from deltoid sites was in-between (see section 4.2).
Maltese: Il-grad ta' l-assorbiment mis-siti tad-deltoid kien jaqa' bejniethom (ara sezzjoni 4.2).
English: Magyarország SANOFI-AVENTIS Zrt.
Maltese: SANOFI-AVENTIS Zrt Tel.:
English: How to store Apidra
Maltese: Tużax Apidra
English: How to handle SoloStar
Maltese: l-użu ta' SoloStar.
English: When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Maltese: Meta titħallat mal-insulina umana NPH, Apidra għandu jittella' l-ewwel fis-siringa.
English: Studies on pharmacokinetic interactions have not been performed.
Maltese: Ma sarux studji fuq interazzjonijiet farmakokinetiċi..
English: Other medicines and Apidra
Maltese: Mediċini oħra u Apidra
English: Type 2 diabetes mellitus-Adults
Maltese: Id-dijabete mellitus tat-tip 2-Adulti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Maltese: Kull ml ta' soluzzjoni fih 100 Unità tas-sustanza attiva insulina glulisine (ekwivalenti għal 3.49 mg).
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen 3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Maltese: Apidra SoloStar 100 Unità/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest 3 ml soluzzjoni fi skartoċċ (ħġieġ mingħajr kulur) bi planġer (lastku bromobutyl elastomeriku) u għatu bi flanġ (ta' l-aluminju) b'tapp (lastku bromobutyl elastomeriku).
English: A 26-week phase III clinical study compared insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in children (4-5 years: n=9; 6-7 years: n=32 and 8-11 years: n=149) and adolescents (12-17 years: n=382) with type 1 diabetes mellitus using insulin glargine or NPH as basal insulin.
Maltese: -il sena: n=149) u adoloxxanti (12-17 -il sena: n=382) bid-dijabete mellitus tat-tip 1, fil-waqt li l insulina glargine jew NPH intużaw bħala insulina bażika.
English: EU/1/04/285/001 1 vial of 10ml EU/1/04/285/002 2 vials of 10ml.
Maltese: EU/1/04/285/002 2 kunjetti ta' 10 ml EU/1/04/285/003 4 kunjetti ta' 10 ml
English: 10 secs
Maltese: 10 sek
English: The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Maltese: Tista' tissettja d-doża f'qabżiet ta' unità waħda, minn minimu ta' unità waħda sa massimu ta' 80 unità.
English: It is made by biotechnology.
Maltese: Hija magħmula permezz tal-bijoteknoloġija.
English: Rare reported side effect (may affect up to 1 in 1,000 people)
Maltese: Effett sekondarju rrapportat b'mod rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuni)
English: Hydrochloric acid, concentrated Sodium hydroxide Water for injections
Maltese: Polysorbate 20 Hydrochloric acid, ikkonċentrat
English: It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Maltese: Tibda taħdem malajr fi żmien 10-20 minuta u ddum taħdem għal perijodu qasir ta' madwar 4 sigħat.
English: Metacresol
Maltese: Trometamol
English: Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
Maltese: L-insulina glulisine hija analogu ta' l- insulina rikombinanti tal-bniedem li hija ekwipotenti ma' linsulina regolari umana.
English: Step 1 Check the insulin
Maltese: Pass Nru. 1 Iċċekkja l-insulina
English: Each ml of the solution contains 100 Units of insulin glulisine (equivalent to 3.49 mg).
Maltese: Kull ml fih 100 Unità insulina glulisine (ekwivalenti għal 3.49 mg).
English: 5 pens of 3 ml.
Maltese: 5 pinen ta' 3 ml
English: There are no specific data available concerning overdoses with insulin glulisine.
Maltese: M'hemmx data speċifika disponibbli dwar dożaġġ eċċessiv bl-insulina glulisine.
English: In a study in patients with type 2 diabetes mellitus after subcutaneous administration of 0.2 Units/kg insulin glulisine, the Cmax was 91 µUnits/ml with the interquartile range from 78 to 104 µUnits/ml.
Maltese: f'doża ta' 0.2 Unitajiet/kg, iċ-Cmax kien 91 µUnitajiet/ml fil-medda interquartile minn 78 sa 104 µUnitajiet/ml.
English: Apidra is injected under the skin (subcutaneously).
Maltese: Apidra huwa injettat taħt il-ġilda (b'mod subkutaneju).
English: Each pen contains 3 ml solution, equivalent to 300 Units.
Maltese: Kull pinna fiha soluzzjoni ta' 3 ml ekwivalenti għal 300 Unità.