FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges.
Maltese: Id-daqsijiet tal-pakketti huma ta' 5 skrataċ u pakkett multiplu li fih 25 skartoċċ (5 pakketti ta' 5).
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/021 2 x (5 x 3 ml)
Maltese: NUMRU TAL- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/119/021 2 x (5 x 3 ml)
English: 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Maltese: 1 x 3 ml pinen mimlijin għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: 1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Maltese: Soluzzjoni ta' 1.6 ml fi skartoċċ (tal-ħġieġ tat-tip 1) bi planġer (tal-bromobutyl) u tapp tal-lastku (talbromobutyl/polyisoprene).
English: The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
Maltese: Il-qawwa tal-analogi tal-insulina, inkluż insulina aspart, hija mfissra f'unitajiet, waqt li l-qawwa tal insulina umana hija mfissra f'unitajiet internazzjonali.
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/015 5 packs of 1 x 10 ml vial
Maltese: EU/1/99/119/015 5 pakketti ta' kunjett 1 x 10 ml
English: If no drop appears, repeat steps F to H up to 6 times.
Maltese: Jekk il-qatra ma tidhirx, irrepeti l-proċeduri minn F sa H sa 6 darbiet.
English: The 0 must line up with the dose pointer.
Maltese: In-numru 0 għandu jiġi bi dritt l-indikatur tad-doża.
English: Avoidance of accidental mix-ups/medication errors
Maltese: TA' PRODOTTI MEDIĊINALI MHUX
English: • Always make sure you have a spare NovoRapid PumpCart available.
Maltese: • Assigura ruħek li dejjem ikollok NovoRapid PumpCart żejjed disponibbli.
English: Follow the pump manual (user guide).
Maltese: Segwi l-manwal tal-pompa (gwida għall-utent).
English: LIST OF EXCIPIENTS glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections.
Maltese: TA' EĊĊIPJENTI glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide għall-aġġustament fil-pH u ilma għall-injezzjonijiet
English: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Maltese: Soluzzjoni ta' 3 ml fi skartoċċ (tal-ħġieġ tat-tip 1) bi planġer (tal-bromobutyl) u tapp tal-lastku (tal bromobutyl/polyisoprene).
English: NovoRapid vial EU/1/99/119/001 EU/1/99/119/008 EU/1/99/119/015
Maltese: NovoRapid FlexPen EU/1/99/119/009 EU/1/99/119/010
English: Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Maltese: L-istudji juru wkoll li d-dissoċjazzjoni tar-rabta ta' insulina aspart minn mar-riċettur ta' l-insulina hija ekwivalenti għal dik ta' insulina umana.
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/024 5 cartridges of 1.6 ml
Maltese: NUMRI TAL- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/119/024 5 skrataċ ta' 1.6 ml.
English: NovoRapid is a rapid-acting insulin analogue.
Maltese: NovoRapid huwa analogu tal-insulina li jaħdem b'mod rapidu.
English: Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to human insulin (see section 5.1).
Maltese: Informazzjoni minn żewġ studji kliniċi magħmula b'mod arbitrarju u kkontrollati (322 u 27 tqala esposti ) ma taw ebda indikazzjoni ta' effett avvers ta' insulina aspart fuq it-tqala jew fuq is-saħħa tal-fetu/tarbija tat-twelid meta mqabbel ma' l-insulina umana (ara sezzjoni 5.1).
English: In a basal-bolus treatment regimen 50-70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin.
Maltese: F'skeda ta' kura bażilari-bolus , 50-70% ta' din il-ħtieġa tista' tingħata minn NovoRapid u l-bqija mill-insulina li taġixxi b'mod intermedju jew fit-tul.
English: Insulin aspart is equipotent to soluble human insulin on a molar basis.
Maltese: Fuq bażi molari, l-insulina aspart hija ekwipotenti ma' insulina umana solubbli.
English: When NovoRapid is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Maltese: Meta injettat minn taħt il-ġilda fiż-żaqq, jibda jaħdem fi żmien 10-20 minuta mill-injezzjoni.
English: NovoRapid PumpCart 100 units/ml solution for injection in cartridge Insulin aspart
Maltese: NovoRapid PumpCart 100 unità/ml soluzzjoni għall-injezzjoni Insulina aspart
English: The maximum effect is exerted between 1 and 3 hours after injection.
Maltese: L-effett massimu jseħħ bejn 1 u 3 sigħat wara l-injezzjoni.
English: After stabilisation of patient's blood glucose adjustment of the dose should be considered (see sections 4.8 and 4.9).
Maltese: Wara li l-glukożju fid-demm tal-pazjent ikun ġie lura għan-normal, wieħed għandu jikkunsidra xi aġġustament fid-doża (ara sezzjonijiet 4.8 u 4.9).
English: ► Always carry a spare NovoRapid PumpCart.
Maltese: ► Dejjem żomm fuqek NovoRapid PumpCart żejjed.
English: a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect.
Maltese: a) Sommarju ta' effetti sekondarji serji u komuni ħafna Livell baxx ta' zokkor fid-demm (ipogliċemija) huwa effett sekondarju komuni ħafna.
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni, tnixxija tal-insulina, labar misduda u doża mhux preċiża.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK (CARTRIDGE.
Maltese: KARTUNA TA' ĠEWWA GĦALL-PAKKETT MULTIPLU (PINNA MIMLIJA GĦAL-LEST.
English: Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycaemia with insulin aspart compared with soluble human insulin.
Maltese: Studji kliniċi f'pazjenti bid-dijabete tat-tip 1 urew li hemm inqas riskju ta' ipogliċemija mal-lejl bl insulina aspart meta mqabbel ma' insulina umana solubbli.
English: FlexTouch - with blue box)
Maltese: FlexTouch- mingħajr il-kaxxa blu)
English: See a) Summary of serious and very common side effects in section 4.
Maltese: (ara a) Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4.
English: Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within 1020 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for more information about how to adjust your bolus dose).
Maltese: NovoRapid jibda jnaqqaslek il-livell taz-zokkor fid-demm fi żmien 10-20 minuta minn meta tibda għotja ta' bolus ( ara sezzjoni 3, Kif għandek tuża NovoRapid PumpCart, għal aktar informazzjoni dwar kif tbiddel id-doża tiegħek tal-bolus).
English: Multipack: 25 (5 packs of 5) cartridges
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni Pakkett multiplu: 25 skartoċċ (5 pakketti ta' 5)
English: 1 pre-filled pen contains 3 ml equivalent to 300 units.
Maltese: NovoRapid Penfill Skartoċċ wieħed fih 3 ml ekwivalenti għal 300 unità.
English: Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Maltese: L-alkoħol jista' jintensifika jew inaqqas l-effett ipogliċemiku ta' l-insulina.
English: • Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
Maltese: • Ormon tat-tkabbir (mediċina li tistimula t-tkabbir skeltrali u somatiku u għandha effett qawwi fuq il-proċessi metaboliċi tal-ġisem)
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Maltese: Ħares mit-tieqa tal-insulina.
English: Pregnancy
Maltese: NovoRapid
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/021 2 x 5 pens of 3 ml
Maltese: NUMRI TAL- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/119/021 2 x 5 pinen ta' 3 ml
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/025 25 (5 packs of 5) cartridges
Maltese: NUMRI TAL- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/119/025 25 skartoċċ (5 pakketti ta' 5)
English: At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
Maltese: Fil-bidu tal-kura bl-insulina, jistgħu jseħħu anomalitajiet ta' rifrazzjoni, edima u reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, nefħa u ħakk fis-sit tal-injezzjoni).
English: MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka
English: During use or when carried as a spare: You can carry your NovoRapid FlexTouch with you and keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks.
Maltese: Tista' ġġorr miegħek in-NovoRapid FlexTouch tiegħek u żżommha f'temperatura taħt 30ºC jew fi friġġ (2˚C sa 8˚C) sa 4 ġimgħat.
English: • Check the expiry date, which is stated on the label and the carton.
Maltese: • Iċċekkja d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna.
English: NovoRapid FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1-80 units in increments of 1 unit.
Maltese: NovoRapid FlexTouch hija pinna mimlija (immarkata b'kuluri differenti) għal-lest u magħmula biex tintuża mal-labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta' mhux iżjed minn 8 mm. FlexTouch jagħti minn unità 1-80 unità f'żidiet ta' unità waħda.
English: Uncommon - Injection site reactions
Maltese: Mhux komuni - Disturbi rifrazzjonali
English: Fig. I. Blood glucose concentrations following a single pre-meal dose of NovoRapid injected immediately before a meal (solid curve) or soluble human insulin administered 30 minutes before a meal (hatched curve) in patients with type 1 diabetes mellitus.
Maltese: Fig. I. Konċentrazzjonijiet tal-glucose fid-demm wara doża waħda qabel l-ikel ta' NovoRapid injettat immedjatament qabel ikla (kurva sħiħa) jew insulina umana solubbli mogħtija 30 minuta qabel ikla (kurva mhux sħiħa) f'pazjenti bid-dijabete mellitus tat-tip 1.
English: • The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Maltese: • Is-sustanzi l-oħra huma glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall-injezzjonijiet
English: NovoRapid FlexPen is a pre-filled, colour-coded, disposable pen containing insulin aspart.
Maltese: Kif timmaniġġja NovoRapid FlexPen NovoRapid FlexPen hija pinna mimlija għal-lest b'kodiċi ta' kulur li tintuża darba biss u fiha insulina aspart.
English: What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice).
Maltese: ► Jekk tesperjenza livell baxx ta' zokkor fid-demm, ħu pilloli tal-glucose jew xi ikla ħafifa b'ħafna zokkor (ħelu, biskuttini, meraq tal-frott).
English: Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Maltese: Is-sinjali ta' livell baxx ta' zokkor: għaraq kiesaħ; ġilda kiesħa u pallida; uġigħ ta' ras; taħbit mgħaġġel tal-qalb, tħossok imqalla'; tħossok ħafna bil-ġuħ; tibdil temporanju fil-vista; ngħas, għeja u debbulizza mhux tas-soltu; nervożitá jew rogħda; tħossok ansjuż; tħossok konfuż; diffikultà filkonċentrazzjoni.
English: During use or when carried as a spare: You can carry your NovoRapid FlexPen with you and keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks.
Maltese: Tista' ġġorr miegħek in-NovoRapid FlexPen tiegħek u żżommha f'temperatura taħt 30ºC jew fi friġġ (2˚C sa 8˚C) sa 4 ġimgħat.
English: NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart
Maltese: NovoRapid Penfill 100 unità/ml Soluzzjoni għall-injezzjoni Insulina aspart
English: • Insert a NovoRapid PumpCart in the cartridge compartment of the pump.
Maltese: • Terġax timla in-NovoRapid PumpCart mill-ġdid.
English: NovoRapid InnoLet EU/1/99/119/012 EU/1/99/119/013 EU/1/99/119/014
Maltese: EU/1/99/119/012 EU/1/99/119/013
English: Administration via Continuous Subcutaneous Insulin Infusion (CSII) NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Maltese: Barra minn hekk, il-kunjett ta' NovoRapid u NovoRapid PumpCart jistgħu jintużaw għall-infużjoni kontinwa tal-insulina minn taħt il-ġilda (CSII) f'sistemi ta' pompi.
English: Uncommon - Oedema
Maltese: Mhux komuni - Lipodistrofija
English: Pen label Dose counter
Maltese: Indikatur tad-doża
English: Mixing two types of insulins
Maltese: Meta jitħalltu żewġ tipi ta' insulini
English: NovoRapid 100 units/ml solution for injection in vial Insulin aspart
Maltese: NovoRapid 100 unitànità/ml soluzzjoni għall-injezzjoni Insulina aspart
English: Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml.
Maltese: Id-daqsijiet tal-pakketti huma ta' pinna 1 (bil-labar jew mingħajrhom), 5 pinen (mingħajr labar) jew pakkett multiplu bi 2 x 5 pinen (mingħajr labar) ta' 3 ml mimlijin għal-lest.
English: During use or when carried as a spare: Store below 37°C (in use) or store below 30°C (carried as a spare).
Maltese: Aħżen f'temperatura taħt 37°C (waqt l-użu) jew aħżen f'temperatura taħt 30°C (meta jinġarr għal li jista' jinqala').
English: ► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very common side effects in section 4).
Maltese: (ara a)Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4).
English: You can select up to 80 units per dose.
Maltese: Tista' tagħżel sa 80 unità f'kull doża.
English: Lipodystrophy:
Maltese: Waqt l-użu:
English: NovoRapid (insulin aspart) can be used in pregnancy.
Maltese: NovoRapid (insulina aspart) jista' jintuża fit-tqala.
English: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Maltese: Soluzzjoni ta' 3 ml fi skartoċċ (tal-ħġieġ tat-tip 1) bi planġer (tal-bromobutyl) u tapp tal-lastku (talbromobutyl/polyisoprene) f'pinna mimlija għal-lest li tagħti dożi multipli u tintrema wara li tintuża kollha, magħmula mill-polypropylene.
English: NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.
Maltese: Waqt l-istudji kliniċi, ma kien hemm ebda differenza fir-rati in ġenerali ta' ipogliċemija, bejn pazjenti kkurati b'insulina aspart u pazjenti kkurati bl-insulina umana.
English: Dose button
Maltese: pompa.
English: 5 x 3 ml pre-filled pens.
Maltese: Tagħmiliex fil-friża.
English: Each cartridge contains 160 units of insulin aspart in 1.6 ml solution for injection.
Maltese: Kull skartoċċ fih 160 unità ta' insulina aspart f'soluzzjoni għall-injezzjoni ta' 1.6 ml.
English: Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see section 6.6).
Maltese: Pazjenti li jużaw CSII għandhom jingħataw istruzzjonijiet dettaljati dwar l-użu tas-sistema tal-pompa, u għandhom jużaw ir-reċipjent u t-tubi korretti għall-pompa (ara sezzjoni 6.6.).
English: Can be stored in a refrigerator (2˚C - 8˚C).
Maltese: Jista' jinħażen fi friġġ (2°C - 8°C).
English: Administration with a syringe NovoRapid vials are for use with insulin syringes with the corresponding unit scale.
Maltese: Indeboliment renali u epatiku L-indeboliment renali jew epatiku jista' jnaqqas il-ħtiġijiet tal-pazjent għall-insulina.
English: INFORMATION IN BRAILLE NovoRapid PumpCart
Maltese: Kif taħżen NovoRapid PumpCart)
English: Pack sizes of 5 and 10 cartridges of 3 ml.
Maltese: Daqsijiet ta' pakketti ta' 5 jew 10 skrataċ ta' 3 ml.
English: NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
Maltese: NovoRapid FlexTouch 100 unità/ml soluzzjoni għall-injezzjoni Insulina aspart
English: NovoRapid FlexTouch is a pre-filled, colour-coded, disposable pen containing insulin aspart.
Maltese: Kif timmaniġġja NovoRapid FlexTouch NovoRapid FlexTouch hija pinna mimlija għal-lest b'kodiċi ta' kulur li tintuża darba biss u li fiha insulina aspart.
English: ► NovoRapid PumpCart is only for use with a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Maltese: ► Biex tkun ċert li qed/a tieħu d-doża korretta, NovoRapid PumpCart m'għandux jintuża f'pinna tal-insulina.
English: Selecting your dose
Maltese: DATA TA' SKADENZA
English: Thereafter it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Maltese: Wara dan iż-żmien jista' jintuża għal mhux aktar minn 7 ijiem f'temperatura taħt 37°C f'pompa magħmula biex tintuża ma' dan l-iskartoċċ, bħal ma huma l-pompi tal-insulina Accu-Chek Insight u YpsoPump.
English: Pack sizes of 5 and 10 cartridges.
Maltese: Id-daqsijiet tal-pakketti huma ta' 5 u 10 skrataċ.
English: NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart
Maltese: NovoRapid FlexPen 100 unità/ml soluzzjoni għall-injezzjoni Insulina aspart
English: Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
Maltese: Tubi li għandhom il-materjal tas-superfiċje intern magħmul mill-polyethylene jew mill-polyolefin ġew evalwati u nstabu li huma kompatibbli mal-użu tal-pompi.
English: Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations.
Maltese: Minħabba din lazzjoni qasira NovoRapid normalment għandu jittieħed flimkien ma' preparazzjonijiet oħrajn ta' insulina li jaġixxu b'effett intermedju jew li jaġixxu fit-tul.
English: Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Maltese: Tibdil fil-qawwa, għamla (manifattur), tip, oriġini ( tal-annimali, insulina umana jew analogu tal-insulina umana) u/jew metodu tal-manifattura (DNA rikombinanti kontra insulina li ġejja millannimali) jista' jirriżulta fil-bżonn ta' tibdil fid-doża.
English: * see section 4.8, Description of selected adverse reactions.
Maltese: Mhux komuni - Reazzjonijiet fis-sit tal-injezzjoni Mhux komuni - Edima * ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: 1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).
Maltese: Skartoċċ fih 1.6 ml ekwivalenti għal 160 unità, Millilitru ta' soluzzjoni fih 100 unità insulina aspart
English: • Replace the big outer needle cap and unscrew the needle (picture 4).
Maltese: • Dejjem iċċekkja li n-NovoRapid PumpCart jidher kif suppost (stampa A).
English: EXPIRY DATE
Maltese: Selettur tad-doża
English: Drinking alcohol and taking NovoRapid
Maltese: Tixrob l-alkoħol u tieħu NovoRapid
English: 5 x 3 ml cartridges
Maltese: 5 x 3 ml pinen mimlijin għal-lest.
English: Each vial contains 1,000 units of insulin aspart in 10 ml solution for injection.
Maltese: Kull kunjett fih 1,000 unità ta' insulina aspart f'soluzzjoni għall-injezzjoni ta' 10 ml.
English: A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those four were younger than 4 years old) and a single dose PK/PD trial was performed in children (612 years) and adolescents (13-17 years).
Maltese: Popolazzjoni pedjatrika Ġie magħmul studju kliniku li qabbel l-insulina umana solubbli mgħoti qabel l-ikel ma' l-insulina aspart mgħoti wara l-ikel fi tfal żgħar (20 pazjent li kellhom minn sentejn sa inqas minn 6 snin, li kienu studjati għal 12-il ġimgħa, li fosthom kien hemm erbgħa li kellhom inqas minn 4 snin) u studju farmakokinetiku/farmakodinamiku b'doża waħda ġie magħmul fit-tfal (6 sa 12-il sena) u fladolexxenti (13 sa 17-il sena).
English: • NovoRapid PumpCart is ready for use directly in the pump.
Maltese: • NovoRapid PumpCart huwa lest għall-użu direttament fil-pompa.
English: Anaphylactic reactions:
Maltese: Problemi bil-vista:
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.
Maltese: Tista' ġġorru miegħek u żżommu f'temperatura ambjentali (inqas minn 30ºC) sa 4 ġimgħat.
English: • Check the label to make sure that it is NovoRapid PumpCart.
Maltese: • Iċċekkja t-tikketta sabiex taċċerta li huwa NovoRapid PumpCart.
English: NovoRapid will start to lower your blood sugar 10-20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours.
Maltese: NovoRapid jibda jnaqqaslek il-livell taz-zokkor fid-demm wara 10-20 minuta mill-injezzjoni, l-effett massimu jseħħ bejn siegħa u 3 sigħat wara l-injezzjoni u l-effett idum għal 3-5 sigħat.
English: The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control (see section 4.8, Description of selected adverse reactions).
Maltese: ipogliċemija jvarjaw skont il-popolazzjoni tal-pazjent, l-iskeda ta' dożaġġ u l-livell tal-kontroll gliċemiku (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi partikulari).
English: • Oral contraceptives (birth control pills)
Maltese: • Kontraċettivi li jittieħdu mill-ħalq (pilloli li jikkontrollaw it-tqala)
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by physicians or other healthcare staff.
Maltese: • Episodji ta' ipogliċemija severa, fejn il-pazjent jintilef minn sensih, jistgħu jiġu kkurati bilglucagon (0.5 sa 1 mg) mogħti minn ġol-muskoli jew minn taħt il-ġilda minn persuna mħarrġa, jew bil-glucose mogħti minn ġol-vini minn tobba jew persuni oħra fil-qasam tal-kura tas-saħħa.
English: The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Kontraċettivi orali, thiazides, glukokortikojdi ormoni tat-tirojde, simpatomimetiċi, l-ormon tat-tkabbir u danazol.
English: NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section 4.2.
Maltese: NovoRapid PumpCart qiegħed biex jintuża biss ma'sistema ta' pompi tal-infużjoni tal-insulina magħmula biex jintużaw ma' dan l-iskartoċċ, bħal ma huma l-pompi tal-insulina Accu-Chek Insight u YpsoPump, kif deskritt f'sezzjoni 4.2.
English: NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Maltese: NovoRapid InnoLet 100 unità/ml soluzzjoni għall-injezzjoni Insulina aspart