FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Maltese: • Jekk it-tieni u t-tielet karattri huma S6,P5,K7, R7, VG, FG jew ZF, il-manifattur huwa, Novo
English: Metabolism and nutrition disorders
Maltese: Distrubi fil-metaboliżmu u nnutrizzjoni
English: Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Maltese: Insulin aspart ġie assorbit b'mod malajr fiż-żewġ gruppi ta' etajiet, b'tmax simili għal dak ta' l-adulti.
English: There is limited clinical experience with NovoMix 30 in children aged 6-9 years (see section 5.1).
Maltese: Għal tfal minn 6 sa 9 snin, l-esperjenza klinika b'NovoMix 30 hija limitata (ara sezzjoni 5.1).
English: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site.
Maltese: Il-lipodistrofija (inkluż il-lipoipertrofija, il-lipoatrofija) tista' sseħħ fis-sit ta' l-injezzjoni.
English: In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
Maltese: F'pazjenti bid-dijabete ta' tip 2, il-konċentrazzjoni massima ntlaħqet madwar 75 minuta wara li ngħatat id-doża.
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 sulfonamides.
Maltese: Mediċini kontra d-dijabete li jittieħdu mill-ħalq, agonisti tar-riċettur ta' GLP-1, inibituri ta' monoamine oxidase (MAOI), sustanzi li jimblukkaw ir-riċetturi beta, inibituri ta' l-enzima li tbiddel angiotensin (ACE), salicylates, alkoħol, sterojdi anaboliċi u sulfonamides.
English: Normally, this soon disappears.
Maltese: Normalment dan malajr imur.
English: Uncommon - Urticaria, rash, eruptions Very rare - Anaphylactic reactions*
Maltese: Mhux komuni - Urtikarja, raxx, eruzzjonijiet Rari ħafna - Reazzjonijiet anafilattiċi
English: Hypoglycaemia:
Maltese: Ipogliċemija:
English: See Resuspension of NovoMix 70 in section 3.
Maltese: Ara suspensjoni mill-ġdid ta' NovoMix 70 f'sezzjoni 3.
English: LIST OF EXCIPIENTS glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections
Maltese: TA' EĊĊIPJENTI glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, ,protamine sulfate, hydrochloric acid/sodium hydroxide għall-aġġustament fil-pH u ilma għall injezzjonijiet
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 ipogliċemiċi serji, meta l-pazjent ikun intilef minn sensih, jistgħu jkunu kkurati bi glucagon (0.5 sa 1 mg) mogħti ġol-muskoli jew minn taħt il-ġilda minn persuna mħarrġa, jew bil-glukosju mogħti minn ġol-vini minn professjonist/a fil-kura tas-saħħa.
English: See c) Effects from diabetes in section 4.
Maltese: Ara Effetti ċ) Effetti mid-dijabete f'sezzjoni 4.
English: See Resuspension of NovoMix 30 in section 3.
Maltese: Ara suspensjoni mill-ġdid ta' NovoMix 30 f'sezzjoni 3.
English: Limited clinical data exists for children aged 6-9 years.
Maltese: Għal tfal bejn 6-9 snin l-informazzjoni klinika hija limitata.
English: Anaphylactic reactions:
Maltese: Reazzjonijiet anafilattiċi:
English: In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
Maltese: F'pazjenti bid-dijabete ta' tip 2, il-konċentrazzjoni massima ntlaħqet madwar 95 minuta wara li ngħatat id-doża.
English: If there are less than 12 units left, use a new FlexPen.
Maltese: Jekk ikun baqa' inqas minn 12-il unità, uża FlexPen ġdida.
English: In patients with type 2 diabetes, a dose reduction of 20% is recommended for patients with an HbA1c less than 8% when a GLP-1 receptor agonist is added to NovoMix 30, to minimise the risk of hypoglycaemia.
Maltese: F'pazjenti bid-dijabete tat-tip 2, huwa rrakkomandat li jkun hemm tnaqqis fid-doża ta' 20 % f'pazjenti b'HbA1c inqas minn 8 % meta agonist tar-riċettur GLP-1 jiżdied ma' NovoMix 30, biex jitnaqqas kemm jista' jkun ir-riskju ta' ipogliċemija.
English: See Resuspension of NovoMix 50 in section 3.
Maltese: Ara suspensjoni mill-ġdid ta' NovoMix 50 f'sezzjoni 3.
English: 5 x 3 ml cartridges
Maltese: 5 x 3 ml skrataċ
English: 1 cartridge contains 3 ml equivalent to 300 units.
Maltese: Pinna mimlija għal-lest fiha 3 ml ekwivalenti għal 300 unità.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 August 2000
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 1 ta'Awwissu, 2000
English: • Drink alcohol (see Drinking alcohol and taking NovoMix 70 in section 2).
Maltese: • Tixrob l-alkoħol (ara Tixrob l-alkoħol u tieħu NovoMix 70 f'sezzjoni 2)
English: NovoMix 70 is a biphasic suspension of the insulin analogue, insulin aspart.
Maltese: NovoMix 70 huwa suspensjoni bifażika ta' analogu tal-insulina, insulin aspart.
English: Other medicines and NovoMix 70
Maltese: Mediċini oħra u NovoMix 70
English: NovoMix 50 is a biphasic suspension of 50% soluble insulin aspart (rapid-acting human insulin analogue) and 50% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Maltese: NovoMix 50 hu suspensjoni bifażika ta' 50 % insulin aspart solubbli (analogu ta' l-insulina umana li jaħdem malajr) u 50 % insulin aspart ikkristallizzat bi protamine (analogu ta' l-insulina umana li jaħdem b'mod intermedju).
English: Rare - Peripheral neuropathy (painful neuropathy)
Maltese: Disturbi fis-sistema nervuża Rari - Newropatija periferali (newropatija bl-uġigħ)
English: See Instructions for use.
Maltese: Ara l-manwal tal-pinna għal aktar istruzzjonijiet.
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 minn sors ta' l-annimali) jista' jirriżulta fil-ħtieġa ta' tibdil fid-doża.
English: INFORMATION IN BRAILLE NovoMix 70 FlexPen
Maltese: INFORMAZZJONI BIL-BRAILLE NovoMix 70 FlexPen
English: • The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.
Maltese: • Is-sustanzi l-oħra huma glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide, u ilma għall-injezzjonijiet.
English: NovoMix 70 FlexPen 100 units/ml
Maltese: NovoMix 70 FlexPen 100 unità/ml
English: NovoMix 70 Penfill 100 units/ml
Maltese: NovoMix 70 Penfill 100 unità/ml
English: Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: In patients with type 2 diabetes, a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
Maltese: F'pazjenti bid-dijabete tat-tip 2, meta-analiżi wriet tnaqqis fin-numru totali ta' riskju ta' episodji ipogliċemiċi ta' matul il-lejl u ta' ipogliċemija maġġuri b'NovoMix 30 meta mqabbla ma' insulina umana bifażika 30.
English: The pharmacokinetics of NovoMix 70 have not been investigated in paediatrics, elderly patients or in patients with renal or hepatic impairment.
Maltese: Il-farmakokinetika ta' NovoMix 70 ma ġietx investigata fil-pedjatrija, f'pazjenti akbar fl-età, jew f'pazjenti b'indeboliment renali jew epatiku.
English: 3 ml suspension 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: Suspensjoni ta' 3 ml f'skartoċċ ( tal-ħġieġ tat-tip 1) bi planġer (bromobutyl) u b'għatu tal-lastku (bromobutyl/polyisoprene) ġo pinna mimlija għal-lest li tagħti iżjed minn doża waħda u li tintrema wara l-użu u magħmula mill-polypropylene.
English: NovoMix 30 Penfill 100 units/ml
Maltese: NovoMix 30 Penfill 100 unità/ml
English: The pharmacokinetics of NovoMix 30 have not been investigated in children or adolescents.
Maltese: Il-farmakokinetika ta' NovoMix 30 ma ġietx investigata la fit-tfal u lanqas fl-adolexxenti.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Maltese: Madankollu, kien hemm differenzi fis-Cmax bejn iż-żewġ gruppi, li jenfasizza l-importanza ta' dożaġġ individwali meta jingħata insulin aspart.
English: NovoMix 70 is indicated for treatment of diabetes mellitus in adults.
Maltese: NovoMix 70 huwa indikat għall-kura tad-dijabete mellitus fl-adulti.
English: • Drink alcohol (see Drinking alcohol and taking NovoMix 30 in section 2).
Maltese: • Tixrob l-alkoħol (ara Tixrob l-alkoħol u tieħu NovoMix 30 f'sezzjoni 2)
English: NovoMix 30 FlexPen 100 units/ml
Maltese: NovoMix 30 FlexPen 100 unità/ml
English: NovoMix 30 is a biphasic suspension of the insulin analogue, insulin aspart.
Maltese: NovoMix 30 huwa suspensjoni bifażika ta' analogu tal-insulina, insulin aspart.
English: Pack sizes of 5 and 10 cartridges of 3 ml.
Maltese: Daqsijiet tal-pakkett ta' 5 u 10 skrataċ ta' 3 ml.
English: Making the injection Insert the needle into your skin.
Maltese: Dan jista' jwassal li persuni jiġu infettati.
English: In insulin aspart, substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin.
Maltese: F'insulin aspart, is-sostituzzjoni ta' l-aċidu amminiku proline b'aspartic acid f'pożizzjoni B28 tnaqqas it-tendenza li jiffurmaw eżameri kif osservat bl-insulina umana li tinħall.
English: NovoMix 50 is a biphasic suspension of the insulin analogue, insulin aspart.
Maltese: NovoMix 50 huwa suspensjoni bifażika ta' analogu tal-insulina, insulin aspart.
English: • Drink alcohol (see Drinking alcohol and taking NovoMix 50 in section 2).
Maltese: • Tixrob l-alkoħol (ara Tixrob l-alkoħol u tieħu NovoMix 50 f'sezzjoni 2)
English: NovoMix 50 Penfill EU/1/00/142/011 EU/1/00/142/012 EU/1/00/142/013
Maltese: Penfill EU/1/00/142/011 EU/1/00/142/012 EU/1/00/142/013 NovoMix 50 FlexPen EU/1/00/142/014
English: Uncommon - Injection site reactions * see Description of selected adverse reactions
Maltese: Mhux komuni - Reazzjonijiet fis-sit tal-injezzjoni ara d-Deskrizzjoni ta' reazzjonijiet avversi magħżulin
English: Uncommon - Lipodystrophy*
Maltese: Mhux komuni - Lipodistrofija
English: Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Maltese: Meta mqabbel ma' insulina umana bifażika, NovoMix 30 jista' jkollu effett iktar qawwi fuq it-tnaqqis tal-glukosju sa 6 sigħat wara l-injezzjoni.
English: In healthy volunteers, a mean maximum serum concentration of 445 ± 135 pmol/l was reached about 60 minutes after a subcutaneous dose of 0.30 unit/kg body weight.
Maltese: F'voluntiera b'saħħithom, il-medja tal-konċentrazzjoni massima fis-serum ta' 445 ± 135 pmol/l intlaħqet madwar 60 minuta wara li ngħatat doża taħt il-ġilda ta' 0.30 unitajiet/kg ta' piż tal-ġisem.
English: The maximum effect is exerted between 1 and 4 hours after injection.
Maltese: L-effett massimu jseħħ bejn 1 u 4 sigħat wara l-injezzjoni.
English: INFORMATION IN BRAILLE NovoMix 70 Penfill
Maltese: INFORMAZZJONI BIL-BRAILLE NovoMix 70 Penfill
English: Pack sizes of 1, 5 and 10 cartridges of 3 ml.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 u 10 skrataċ ta' 3 ml.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
Maltese: ► Jekk tissuspetta li ser tibda l-ipogliċemija (zokkor baxx fid-demm),ara a) Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4.
English: NovoMix 70 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 70 is essentially ‘sodium-free'.
Maltese: Kull doża ta' NovoMix 70 fiha inqas minn 1 mmol ta' sodium (23 mg), jiġifieri NovoMix 70 huwa bażikament ‘bla sodium'.
English: Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Maltese: Il-livell finali ta' HbA1c kien b'mod sinifikanti inqas fil-grupp ikkurat b'insulina umana 30 bifażika meta mqabbel ma' dak ikkurat b'NovoMix 30.
English: NovoMix 30 is a biphasic suspension of 30% soluble insulin aspart (rapid-acting human insulin analogue) and 70% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Maltese: NovoMix 30 hu suspensjoni bifażika ta' 30 % insulin aspart solubbli (analogu tal-insulina umana li jaħdem malajr) u 70 % insulin aspart ikkristallizzat bi protamine (analogu tal-insulina umana li jaħdem b'mod intermedju).
English: NovoMix 70 is a biphasic suspension of 70% soluble insulin aspart (rapid-acting human insulin analogue) and 30% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Maltese: NovoMix 70 hu suspensjoni bifażika ta' 70 % insulin aspart solubbli (analogu ta' l-insulina umana li jaħdem malajr) u 30 % insulin aspart ikkristallizzat bi protamine (analogu ta' l-insulina umana li jaħdem b'mod intermedju).
English: The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
Maltese: Il-medja tal-half life (t½) ta' NovoMix 30, li tirrifletti r-rata ta' assorbiment tal-porzjon imwaħħal ma' protamine, kienet ta' madwar 8-9 sigħat.
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: Lintensifikazzjoni tat-terapija bl-insulina, b'titjib f'daqqa fil-kontroll gliċemiku, tista' tkun assoċjata ma' retinopatija dijabetika li b'mod temporanju tmur għall-agħar waqt li titjib fil-kontroll gliċemiku fit-tul inaqqas ir-riskju tal-progressjoni tar-retinopatija dijabetika.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and
Maltese: Wara li l-livell tal-glukożju fid-demm ikun ġie stabbli, wieħed għandu jikkunsidra aġġustament fid-doża (ara sezzjonijiet 4.2, 4.8 u 4.9).
English: In healthy volunteers, a mean maximum serum concentration of 645 ± 185 pmol/l was reached about 60 minutes after a subcutaneous dose of 0.30 unit/kg body weight.
Maltese: F'voluntiera b'saħħithom, il-medja tal-konċentrazzjoni massima fis-serum ta' 645 ± 185 pmol/l intlaħqet madwar 60 minuta wara li ngħatat doża taħt il-ġilda ta' 0.30 unitajiet/kg ta' piż tal-ġisem.
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, anomaliji fir-rifrazzjoni, edima u reazzjonijiet fis-sit talinjezzjoni (uġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, nefħa u ħakk fis-sit tal-injezzjoni).
English: NovoMix 70 may be used in combination with metformin.
Maltese: NovoMix 70 jista' jintuża flimkien ma' metformin.
English: For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal).
Maltese: Għall-pazjenti b'dijabete ta' tip 2, id-doża tal-bidu rakkomandata ta' NovoMix 30 hi ta' 6 unitajiet waqt il-kolazzjon u ta' 6 unitajiet waqt il-pranzu (l-ikla ta' filgħaxija).
English: • Inject too much insulin.
Maltese: • Ma injettajtx biżżejjed insulina
English: The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Maltese: Il-konċentrazzjoni massima ta' insulina fis-serum hi, bħala medja, 50% ogħla b'NovoMix 30 milli blinsulina umana bifażika 30.
English: 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine SC use
Maltese: 50 % insulin aspart solubbli u 50 % insulin aspart ikkristallizzat bi protamine Għal użu taħt il-ġilda
English: In one study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycaemic agents alone, were randomised to treatment with twice daily NovoMix 30 (117 patients) or once daily insulin glargine (116 patients).
Maltese: Fi studju wieħed, pazjenti bid-dijabete ta' tip 2, li ma kienux ikkontrollati b'mod suffiċjenti permezz ta' mediċini orali ipogliċemiċi waħidhom, kienu magħżula b'mod każwali għal kura jew b'NovoMix 30 darbtejn kuljum (117-il pazjent) jew b'insulin glargine darba kuljum (116-il pazjent).
English: Other medicines and NovoMix 50
Maltese: Mediċini oħra u NovoMix 50
English: In a 3 month trial in patients with type 1 and type 2 diabetes, NovoMix 30 showed equal control of glycosylated haemoglobin compared to treatment with biphasic human insulin 30.
Maltese: Fi studju ta' 3 xhur f'pazjenti bid-dijabete ta' tip 1 u tip 2, NovoMix 30 wera kontroll ugwali ta' emoglobina glikosilata meta mqabbel mal-kura b'insulina umana bifażika 30.
English: Suspension for injection in cartridge
Maltese: Suspensjoni għall-injezzjoni
English: Other medicines and NovoMix 30
Maltese: Mediċini oħra u NovoMix 30
English: Uncommon - Injection site reactions
Maltese: Mhux komuni - Disturbi fir-rifrazzjoni
English: The pharmacokinetics of NovoMix 50 have not been investigated in paediatrics, elderly patients or in patients with renal or hepatic impairment.
Maltese: Il-farmakokinetika ta' NovoMix 50 ma ġietx investigata fil-pedjatrija, f'pazjenti anzjani, jew f'pazjenti b'indeboliment renali jew epatiku.
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: NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
Maltese: NovoMix 70 hu insulina bifażika li fiha 70% insulin aspart li jinħall.
English: NovoMix 50 may be used in combination with metformin.
Maltese: NovoMix 50 jista' jintuża flimkien ma' metformin.
English: Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection.
Maltese: Kull skartoċċ fih 300 unità ta' insulin aspart f'suspensjoni għall-injezzjoni ta' 3 ml.
English: 1 pre-filled pen contains 3 ml equivalent to 300 units
Maltese: Pinna mimlija għal-lest fiha 3 ml ekwivalenti għal 300 unità
English: NovoMix 30 can be used in elderly patients; however there is limited experience with the use of NovoMix 30 in combination with oral antidiabetic medicinal products in patients older than 75 years.
Maltese: NovoMix 30 jista' jintuża f'pazjenti anzjani; madankollu l-esperjenza hija limitata fl-użu ta' NovoMix 30 flimkien ma' prodotti mediċinali antidijabetiċi orali f'pazjenti ikbar minn 75 sena.
English: Figure 1: Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
Maltese: Figura 1: Il-Profil ta' l-Attività għal NovoMix 70 f'Pazjenti Kawkasi b'Saħħithom
English: Pre-meal blood glucose level
Maltese: GĦAMLA KWALITATTIVA
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 tal-insulina, labar imblokkati u dożaġġ li ma jkunx preċiż.
English: NovoMix 70 FlexPen EU/1/00/142/020 EU/1/00/142/021 EU/1/00/142/022
Maltese: NovoMix 70 FlexPen EU/1/00/142/020
English: • Repeat the rolling and moving procedures (see pictures A and B) until the liquid appears uniformly white, cloudy and aqueous.
Maltese: • Irrepeti l-proċeduri ta' l-irrumblar u taċ-ċaqliq (ara stampi A u B) sakemm b'mod uniformi llikwidu jidher abjad, opak u akweju.
English: Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq it-tikketta u l-kartuna tal-FlexPen, wara ‘EXP'.
English: NovoMix 70 FlexPen Glass ball
Maltese: NovoMix 70 FlexPen Ballun talħġieġ
English: When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Maltese: Meta NovoMix 50 ikun injettat minn taħt il-ġilda, jibda jaħdem fi żmien 10 sa 20 minuta millinjezzjoni.
English: Transfer from other insulin medicinal products
Maltese: It-trasferiment minn prodotti mediċinali oħra tal-insulina
English: Pack sizes of 1, 5 and 10 cartridges.
Maltese: Pakketti ta' daqsijiet ta' 1, 5 jew 10 skartoċċi.
English: Dose selector
Maltese: Għatu talpinna
English: When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Maltese: Meta NovoMix 70 ikun injettat minn taħt il-ġilda, jibda jaħdem fi żmien 10 sa 20 minuta millinjezzjoni.
English: • Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white, cloudy and aqueous.
Maltese: • Irrepeti l-proċeduri ta' l-irrumblar u taċ-ċaqliq (ara stampi A u B) sakemm b'mod uniformi llikwidu jidher proprju abjad, opak u akweju.
English: NovoMix 50 is indicated for treatment of diabetes mellitus in adults.
Maltese: NovoMix 50 huwa indikat għall-kura tad-dijabete mellitus fl-adulti.
English: The safety and efficacy of NovoMix 50 in children below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' NovoMix 50 fit-tfal taħt l-età ta' 18-il sena ma ġewx stabbiliti.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Maltese: Każijiet ta' reazzjonijiet ta' sensittività eċċessiva ġeneralizzata (li jinkludu raxx ġeneralizzat fil-ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n-nifs, palpitazzjoni u tnaqqis fil-pressjoni tad-demm) huma rari ħafna iżda jistgħu potenzjalment ikunu ta' periklu għall-ħajja.
English: NovoMix 70 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Maltese: NovoMix 70 FlexPen hija pinna mimlija għal-lest (b'kulur partikolari) magħmula biex tintuża mallabar NovoFine jew NovoTwist.
English: The primary efficacy variable - HbA1c after 16 weeks of treatment - did not differ between patients with NovoMix 30 combined with metformin and patients with metformin plus sulfonylurea.
Maltese: Il-varjabbli primarju ta' l-effikaċja - HbA1c wara 16-il ġimgħa ta' kura - ma kienx differenti bejn pazjenti b'NovoMix 30 flimkien ma' metformin u pazjenti b'metformin flimkien ma' sulfonylurea.
English: Instruction on how to use NovoMix 50 suspension for injection in FlexPen.
Maltese: Istruzzjonijiet dwar kif tuża NovoMix 50 suspensjoni għall-injezzjoni ġo FlexPen.
English: NovoMix 50 Penfill 100 units/ml suspension for injection in a cartridge 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Maltese: Penfill 100 unità/ml suspensjoni għall-injezzjoni fi skartoċċ 50 % insulin aspart solubbli u 50 % insulin aspart ikkristallizzat bi protamine
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.
Maltese: F'dak li għandu x'jaqsam mal-fertilità, studji ta' riproduzzjoni fl-annimali ma wrew l-ebda differenza bejn insulin aspart u insulina umana.