FrancophonIA/ELRC3.0 huggingface dataset:
English: • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough.
Maltese: • artrite psorjatika (artrite flimkien ma' psorijażi, kundizzjoni li tikkawża rqajja' ħomor bil-qoxra fuq il-ġilda) fl-adulti li fuqhom kura b'mediċini oħra, inkluż il-methotrexate, ma tkunx ħadmet tajjeb biżżejjed.
English: T cells are activated when signal molecules attach to receptors on the cells.
Maltese: Iċ-ċelloli T jiġu attivati meta molekuli ta' sinjal jeħlu ma' riċetturi fuq iċ-ċelloli.
English: Orencia is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in pre-filled syringes and pre-filled pens.
Maltese: Orencia huwa disponibbli bħala trab li jsir soluzzjoni għal infużjoni (dripp) fil-vina u bħala soluzzjoni għall-injezzjoni taħt il-ġilda f'siringi u pinen mimlija lesti.
English: What benefits has Orencia have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Orencia li ħarġu mill-istudji?
English: The main measure of effectiveness was a reduction in symptoms of at least 20% after 24 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis fis-sintomi ta' mill-anqas 20 % wara 24 ġimgħa ta' kura.
English: All patients received Orencia for 4 months, after which the 122 whose condition had improved on Orencia were either switched to placebo or continued receiving Orencia.
Maltese: Il-pazjenti kollha ngħataw Orencia għal erba' xhur, u wara, dawk il-122 li l-kundizzjoni tagħhom kienet tjiebet b'Orencia, jew inqelbu għal plaċebo jew baqgħu jirċievu Orencia.
English: The second study found a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
Maltese: It-tieni studju wera effett simili ta' Orencia fuq is-sintomi talartrite rewmatojde, kif ukoll titjib fil-funzjoni fiżika u rata mnaqqsa ta' ħsara fil-ġogi wara sena ta' kura.
English: T cells are immune system cells that are involved in causing the inflammation in rheumatoid, psoriatic and polyarticular juvenile idiopathic arthritis.
Maltese: Is-sustanza attiva f'Orencia, l-abataċett, hija proteina li trażżan l-attivazzjoni taċ-ċelloli T. Iċ-ċelloli T huma ċelloli tas-sistema immunitarja li huma involuti fl-ikkawżar ta' infjammazzjoni fl-artrite rewmatojde, fl-artrite psorjatika u fl-artrite idjopatika ġuvenili poliartikulata.
English: The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the ability to carry out everyday tasks) and the amount of damage to the joints (assessed using X-rays).
Maltese: Il-kejl ewlieni tal-effikaċja kienu t-tnaqqis fis-sintomi tal-artrite wara l-kura, kif ukoll il-funzjoni fiżika (il-ħila li jsiru l-attivitajiet ta' kuljum) u l-ammont ta' ħsara fil-ġogi (vvalutati bir-raġġi -X).
English: In polyarticular juvenile idiopathic arthritis, Orencia infusion was found effective in one main study involving patients aged between 6 and 17 years whose previous treatment had not worked.
Maltese: Fl-artrite idjopatika ġuvenili poliartikulata, l-infużjoni b'Orencia nstabet effettiva fi studju ewlieni wieħed li kien jinvolvi pazjenti bejn sitt snin u 17-il sena li l-kura preċedenti tagħhom ma kinitx ħadmet.
English: In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.
Maltese: Barra minn hekk, studju li jinvolvi lil madwar 1,370 pazjent bl-artrite rewmatojde sab benefiċċju simili kemm għal Orencia mogħti b'injezzjoni taħt il-ġilda kif ukoll għal Orencia mogħti b'infużjoni.
English: The study also led to similar improvements in symptoms to those seen with Orencia given into a vein in adults and children.
Maltese: L-istudju wassal ukoll għal titjib fis-sintomi simili għal dawk li dehru b'Orencia mogħti fil-vina lill-adulti u lit-tfal.
English: The European Medicines Agency concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li Orencia għandu effett anti-infjammatorju modest flartrite rewmatojde, u meta ntuża ma' methotrexate naqqas l-iggravar tal-ħsara fil-ġogi u tejjeb ilfunzjoni fiżika.
English: Difference:
Maltese: Differenza:
English: 41% 32% Odds Ratio:
Maltese: 41% 32% Proporzjon ta' Probabbiltà:
English: Date of last renewal: 16 April 2009
Maltese: Data tal-aħħar tiġdid: 16 ta' April 2009
English: Levemir CV (%)
Maltese: CV (%)
English: AUCGIR,0-24h*
Maltese: AUCGIR,0-24siegħa*
English: This reduces the risk of contamination, infection,
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni,
English: * see section 4.8, Description of selected adverse reactions.
Maltese: * ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: • The active substance is insulin detemir.
Maltese: • Is-sustanza attiva hi insulin detemir.
English: Maternal glycaemic control Levemir NPH Difference/ Odds Ratio/ Rate Ratio 95% CI
Maltese: Kontroll gliċemiku matern Levemir NPH Differenza/ Proporzjon ta' Probabbiltà/ Proporzjon ta' Rata 95% CI
English: Glucose infusion rate (mg/kg/min)
Maltese: Rata ta' infuzjoni tal-glucose (mg/kg/min)
English: +8 units
Maltese: +8 unitajiet
English: Levemir was the basal insulin product for 33% (n=147) of the patients (97.3% using metformin).
Maltese: Levemir kien il-prodott ta' insulina bażilari għal 33% (N =147) tal-pazjenti (97.3% kienu qed jużaw metformin).
English: Modern insulin products are improved versions of human insulin.
Maltese: Prodotti ta' insulini moderni huma verżjonijiet imtejba ta' insulina umana.
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: Avenue d'Orléans, F-28000 Chartres, Franza.
English: Uncommon - Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions*
Maltese: Mhux komuni - Reazzjonijiet allerġiċi, reazzjonijiet potenzjalment allerġiċi, urtikarja, raxx, eruzzjonijiet*
English: 1 unit insulin detemir corresponds to 1 international unit of human insulin.
Maltese: Unità 1 ta' insulin detemir tikkorrispondi għal unità internazzjonali 1 ta' insulina umana.
English: Pharmacodynamic Parameters for Levemir and NPH
Maltese: Parametri Farmakodinamici għal Levemir u NPH Levemir
English: The terminal half-life is between 5 and 7 hours depending on the dose.
Maltese: Il-half life terminali huwa bejn 5 sa 7 sigħat jiddependi mid-doża.
English: -4 units
Maltese: -4 unitajiet
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Maltese: • Simpatomimetiċi ( bħal epinephrine [adrenaline] jew salbutamol, terbutaline użati fil-kura tal-ażma)
English: It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Maltese: Jista' wkoll jintuża flimkien ma' prodotti mediċinali antidijabetiċi orali u/jew agonisti tar-riċettur GLP-1.
English: Insulins and analogues for injection, long-acting: ATC code: A10AE05.
Maltese: Kodiċi ATC: A10AE05.
English: Duration of action (hr) GIRmax (mg/kg/min) †estimated values
Maltese: GIRmax (mg/kg/min) valuri stmati
English: Mean HbA1c (%) at GW 36
Maltese: Medja ta' HbA1c (%) f'ĠĠ 36
English: EU/1/04/278/004 1 pen of 3 ml EU/1/04/278/005 5 pens of 3 ml EU/1/04/278/006 10 pens of 3 ml EU/1/04/278/010 1 pen of 3 ml and 7 NovoFine needles EU/1/04/278/011 1 pen of 3 ml and 7 NovoTwist needles
Maltese: EU/1/04/278/004 pinna ta' 3 ml EU/1/04/278/005 5 pinen ta' 3 ml EU/1/04/278/006 10 pinen ta' 3 ml EU/1/04/278/010 pinna ta' 3 ml u 7 labar NovoFine EU/1/04/278/011 pinna ta' 3 ml u 7 labar NovoTwist
English: Degradation of insulin detemir is similar to that of human insulin; all metabolites formed are inactive.
Maltese: Id-degradazzjoni ta' insulin detemir hija simili għal dik ta' l-insulina umana; il-metaboliti kollha li jiffurmaw huma inattivi.
English: For storage conditions of the medicinal product, see section 6.3.
Maltese: Għal kondizzjonijiet ta' ħażna tal-prodott mediċinali, ara sezzjoni 6.3.
English: Very rare - Anaphylactic reactions*
Maltese: Rari ħafna - Reazzjonijiet anafilattiċi*
English: *Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *Insulin detemir hu magħmul fis-Saccharomyces cerevisiae permezz tat-teknoloġija tad-DNA rikombinanti.
English: The 0 must line up with the dose pointer.
Maltese: In-numru 0 irid ikun bi dritt l-indikatur tad-doża.
English: The trial started with a 12-week run-in period with liraglutide+metformin, where 61% reached an HbA1c <7%.
Maltese: L-istudju beda b'perijodu inizjali ta' 12-il ġimgħa b'liraglutide+metformin, fejn 61% laħqu HbA1c <7%.
English: In trials investigating the use of oral antidiabetic medicinal products, combination therapy with Levemir resulted in a 61-65% lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
Maltese: Fi studji li investigaw l-użu ta' prodotti mediċinali antidijabetiċi orali, irriżulta li meta jittieħdu flimkien ma' Levemir kien hemm 61-65% ta' riskju inqas ta' ipogliċemija minuri ta' matul il-lejl meta mqabbla ma' insulina NPH.
English: The following substances may reduce the patient's insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
Maltese: Prodotti mediċinali kontra d-dijabete li jittieħdu mill-ħalq, agonisti tar-riċettur GLP-1, inibituri ta' monoamine oxidase (MAOI), beta-blokkanti, inibituri ta' l-enżima li tibdel angiotensin (ACE), salicylates, sterojdi anaboliċi u sulphonamides.
English: Rate Ratio:
Maltese: Proporzjon ta' Rata:
English: However, when used in combination with oral antidiabetic medicinal products, three clinical studies have shown a frequency of common (2.2% of allergic reactions and potentially allergic reactions have been observed).
Maltese: Madankollu meta jintuża flimkien ma' prodotti mediċinali antidijabetiċi orali, tliet studji kliniċi wrew frekwenza ta' komuni ( ġew osservati 2.2 % ta' reazzjonijiet allerġiċi u ta' reazzjonijiet potenzjalment allerġiċi).
English: NPH insulin Insulin glargine
Maltese: Insulina NPH Insulina glargine
English: Getting started
Maltese: Novo Allé
English: +3 units
Maltese: +3 unitajiet
English: Mean change in HbA1c from baseline (%)
Maltese: Żieda medja fl-HbA1c milllinja bażi (%)
English: Each ml contains 100 units of insulin detemir.
Maltese: Kull ml fih 100 unità ta' insulin detemir.
English: See table 3.
Maltese: Ara tabella 3.
English: 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg).
Maltese: Millilitru tas-soluzzjoni fih 100 unità ta' insulin detemir* (ekwivalenti għal 14.2 mg).
English: 1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg).
Maltese: Millilitru ta' soluzzjoni fih 100 unità ta' insulin detemir (ekwivalenti għal 14.2 mg).
English: The pharmacokinetic properties of Levemir were investigated in young children (1-5 years), children (6-12 years) and adolescents (13-17 years) and compared to adults with type 1 diabetes.
Maltese: Il-karatteristiċi farmakokinetiċi ta' Levemir ġew investigati fit-tfal żgħar (1-5 snin), tfal (6-12-il sena) u fladoloxxenti (13-17-il sena) u mqabbla ma' adulti b'dijabete ta' tip 1.
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Maltese: Dan jista' jnaqqas ir-riskju li tiżviluppa xi għoqiedi jew li titħaffer il-ġilda (ara sezzjoni 4, Effetti sekondarji possibbli).
English: Store below 30°C Do not freeze
Maltese: Aħżen f'temperatura inqas minn 30°C .
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium Hydroxide (għall-aġġustament tal-pH)
English: Clinical trial data - Levemir add-on to liraglutide+metformin Study week Randomised
Maltese: Tabella 3. Dejta tal-istudju kliniku - Levemir bħala żieda ma' liraglutide+metformin
English: Dose counter stopped: 52 units left
Maltese: Ilkontatur tad-doża waqaf: fadal 52 unità f
English: Levemir InnoLet and FlexTouch
Maltese: Levemir InnoLet u FlexTouch
English: Metabolism and nutrition disorders
Maltese: Distrubi fil-metaboliżmu u n nutrizzjoni
English: NAME OF THE MEDICINAL PRODUCT Levemir 100 units/ml
Maltese: Levemir 100 unità/ml
English: The trials demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin degludec when given as basal-bolus therapy, using a noninferiority margin of 0.4%.
Maltese: Il-provi wrew li l-kontroll gliċemiku (HbA1c) b'Levemir kien simili għal dak blinsulina NPH u insulina degludec meta mogħtija bħala terapija bażali - bolus, bl-użu ta' marġni ta' noninferiority ta' 0.4 %.
English: .0.4 U/kg
Maltese: .2 U/kg 0.3 U/kg 0.4
English: The insulin dose was reduced by 20% for patients with baseline HbA1c ≤8.0% in order to minimise the risk of hypoglycaemia.
Maltese: Id-doża tal-insulina kienet imnaqqsa b'20% għal pazjenti li kellhom linja ta' bażi ta' HbA1c ≤ 8.0% sabiex jitnaqqas kemm jista' jkun ir-riskju ta' ipogliċemija.
English: Addition of Levemir provided a further reduction of HbA1c from 7.6% to 7.1% after 52 weeks.
Maltese: Iż-żieda ta' Levemir wassal għal iżjed tnaqqis fl-HbA1c minn 7.6% għal 7.1% wara 52 ġimgħa.
English: LIST OF EXCIPIENTS glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections
Maltese: TA' EĊĊIPJENTI glycerol, phenol, metacresol, zinc acetate, 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) contained in a pre-filled multidose disposable pen made of polypropylene.
Maltese: Soluzzjoni ta' 3 ml f'skartoċċ (ħġieġ ta' tip 1) bi planġer (bromobutyl) u tapp tal-lastku (bromobutyl/polyisoprene).
English: There were no clinically relevant differences in pharmacokinetic properties between young children, children, adolescents and adults.
Maltese: Ma kienx hemm differenzi klinikament rilevanti fil-karatteristiċi farmakokinetiċi bejn tfal żgħar, tfal, adolexxenti u adulti.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti (ara sezzjoni 6.1).
English: In these patients, addition of liraglutide resulted in a greater decline in HbA1c compared to addition of placebo (to 6.93% vs. to 8.24%), a greater decline in fasting plasma glucose (to 7.20 mmol/l vs. to 8.13 mmol/l), and a greater decline in body weight (-3.47 kg vs. -0.43 kg).
Maltese: F'dawn il-pazjenti , iż-żieda ta' liraglutide waslet għal tnaqqis akbar fl-HbA1c meta mqabbla maż-żieda tal-plaċebo (sa 6.93% vs. sa 8.24%), tnaqqis akbar fil-livell tal-glukosju fil-plażma fl-istat sajjem (sa 7.20 mmol/l vs. sa 8.13 mmol/l), u tnaqqis akbar fil-piż tal-ġisem (-3.47 kg vs. -0.43 kg).
English: Insulin cartridge
Maltese: Insulin detemir
English: You can select doses from 1 to 60 units in increments of 1 unit.
Maltese: Tista' tisselezzjona dożi minn 1 sa 60 unità f'inkrementi ta' unità 1.
English: • The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Maltese: • L-ingredjenti l-oħra huma glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall-injezzjonijiet.
English: GIRmax** *Area under the curve ** Glucose Infusion Rate p-value <0.001 for all comparisons with Levemir
Maltese: GIRmas** *Erja taħt il-kurva **Rata ta' Infużjoni tal-Glukosju valur p <0.
English: The time action profile of Levemir is statistically significantly less variable and therefore more predictable than for NPH (Neutral Protamine Hagedorn) insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Maltese: Il-profil ta' l-azzjoni mal-ħin ta' Levemir huwa statistikament ferm inqas varjabbli u għalhekk jista' jitbassar iktar milli għall-insulina NPH (Neutral Protamine Hagedorn) kif jidher mill-Ko-effiċjenti tal-Varjazzjoni (CV) fl-istess suġġett għall-effett farmakodinamiku totali u massimu f'Tabella 1.
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: - If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Maltese: - Jekk it-tieni u t-tielet karattri huma S6, P5, K7, R7, VG,FG jew ZF, il-manifattur huwa Novo Nordisk
English: For doses in the interval of 0.2-0.4 units/kg (U/kg), Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Maltese: 0.4 unitajiet/kg (U/kg), Levemir jeżerċita iktar minn 50% ta' l-effett massimu tiegħu minn 3-4 sigħat u samadwar 14-il siegħa wara l-għoti tad-doża.
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 a healthcare professional.
Maltese: • Episodji ipoglikemiċi serji, meta l-pazjent ikun intilef minn sensih, jistgħu jiġu ttrattati bi glucagon (0.5 sa 1 mg) mogħti ġol-muskoli jew taħt il-ġilda minn persuna mħarrġa jew bil-glukosju li jingħata ġol-vina minn professjonist fil-kura tas-saħħa.
English: Levemir dose adjustment
Maltese: Tfal u adolexxenti
English: The results of the in vitro and in vivo protein binding studies suggest that there is no clinically relevant interaction between insulin detemir and fatty acids or other protein bound medicinal products.
Maltese: Ir-riżultati ta' studji ta' rbit mal-proteini kemm in vitro u kemm in vivo jindikaw li m'hemm ebda interazzjoni klinikament rilevanti bejn insulin detemir u l-aċidi grassi jew ma' prodotti mediċinali oħra li jintrabtu mal-proteini.
English: EU/1/04/278/014 5 pens of 3 ml.
Maltese: EU/1/04/278/014 5 pinen ta' 3 ml.
English: Can be stored in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C) .
English: 5 x 3 ml pre-filled pens 2 x (5 x 3 ml) pre-filled pens 1 x 3 ml pre-filled pen + 7 NovoFine needles 1 x 3 ml pre-filled pen + 7 NovoTwist needles
Maltese: 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 2 x (5 x 3 ml)pinen mimlijin għal-lest 1 x 3 ml pinna mimlija għal-lest+ 7 labar NovoFine 1 x 3 ml pinna mimlija għal-lest + 7 labar NovoTwist
English: EU/1/04/278/010 EU/1/04/278/011
Maltese: EU/1/04/278/011
English: In the trial comparing Levemir vs. insulin degludec, the rate of hyperglycaemic episodes with ketosis was significantly higher for Levemir, 1.09 and 0.68 episodes per patient-year of exposure, respectively.
Maltese: Fil-prova li qabblet Levemir vs insulina degludec, ir-rata ta' episodji ipergliċemiċi b'ketosi kienet ogħla b'mod sinifikanti b'Levemir, 1.09 u 0.68 ta' episodju għal kull sena ta' esponiment talpazjent, rispettivament.
English: There were no major hypoglycaemic episodes.
Maltese: Ilma għall-injezzjonijiet
English: Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions are uncommon when Levemir is used in basal-bolus regimen.
Maltese: Reazzjonijiet allerġiċi, reazzjonijiet potenzjalment allerġiċi, urtikarja, raxx, eruzzjonijiet Reazzjonijiet allerġiċi, reazzjonijiet potenzjalment allerġiċi, urtikarja, raxx u eruzzjonijiet mhumiex komuni meta Levemir jintuża f'dożaġġ ta' bolus-bażilari.
English: Levemir provides up to 24 hours of basal insulin coverage.
Maltese: Levemir jipprovdi sa 24 siegħa ta' kopertura ta' insulina bażilari.
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or 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, marka (manifattur), tip, oriġini (insulina mill-annimali, insulina umana, jew analogu tal-insulina ) u/jew fil-metodu ta' manifattura (DNA rikombinanti kontra insulina li ġejja millannimali) jista' jirriżulta fil-ħtieġa ta' bidla fid-doża.
English: Dose pointer
Maltese: Tikketta talpinna
English: Levemir is a modern insulin (insulin analogue) with a long-acting effect.
Maltese: Levemir huwa insulina moderna (analogu tal-insulina) li jaħdem fit-tul.
English: Your Levemir FlexTouch pen is a pre-filled insulin pen Levemir FlexTouch contains 300 units of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.
Maltese: Levemir FlexTouch fiha 300 unità ta' insulina u tagħti dożi minn 1 sa 80 unità, f'inkrementi ta' unità 1.
English: 6, Contents of the pack and other information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra.
English: Levemir®
Maltese: Levemir® FlexTouch®
English: Studies in patients with type 2 diabetes treated with basal insulin in combination with oral antidiabetic medicinal products demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin glargine and associated with less weight gain, see Table 2 below.
Maltese: Studji f'pazjenti bid-dijabete ta' tip 2 ikkurati b'insulina bażilari flimkien ma' prodotti mediċinali antidijabetiċi orali wrew li l-kontroll gliċemiku (HbA1c) b'Levemir huwa simili għal dak b'insulina NPH u b'insulina glargine u assoċjat ma' żieda inqas fil-piż, jekk jogħġbok ara Tabella 2 hawn taħt.
English: Levemir was studied in an open-label randomised controlled clinical trial, pregnant women with type 1 diabetes (n=310) were treated in a basal-bolus treatment regimen with Levemir (n=152) or NPH insulin (n=158) as basal insulin, both in combination with NovoRapid (see section 4.6).
Maltese: Levemir ġie studjat f'studju kliniku ‘open-label', ikkontrollat u magħmul b'mod arbitrarju, fejn nisa tqal bid-dijabete tat-tip 1 (n=310) ġew ikkurati b'skeda ta' kura bażilari-bolus b'Levemir (n=152) jew b'NPH insulin (n=158) bħala insulina bażilari, it-tnejn flimkien ma' NovoRapid (ara sezzjoni 4.6).
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni, infezzjoni, telf ta' insulina, labar imblokkati u dożaġġ li ma jkunx eżatt.
English: Pack sizes of 1, 5 and 10 cartridges of 3 ml.
Maltese: Daqsijiet ta' pakketti ta' 1, 5 u 10 skrataċ ta' 3 ml.
English: See c) Effects from diabetes in section 4.
Maltese: Ara ċ) Effetti taddijabete f'sezzjoni 4.
English: In an open-label randomised controlled clinical trial pregnant women with type 1 diabetes (n=310) were treated in a basal-bolus treatment regimen with Levemir (n=152) or NPH insulin (n=158) as basal insulin, both in combination with NovoRapid.
Maltese: F'studju kliniku ‘open-label', ikkontrollat u magħmul b'mod arbitrarju, nisa tqal bid-dijabete tat-tip 1 (n=310) ġew ikkurati b'skeda ta' kura bażilari-bolus b'Levemir (n=152) jew b'NPH insulin (n=158) bħala insulina bażilari, it-tnejn flimkien ma' NovoRapid.
English: EU/1/04/278/012 1 pen of 3 ml
Maltese: EU/1/04/278/012 pinna ta'3 ml
English: Maximum serum concentration is reached between 6 and 8 hours after administration.
Maltese: Il-konċentrazzjoni massima tas-serum tintlaħaq bejn 6 sa 8 sigħat wara l-għoti.