qanastek/EMEA-V3 huggingface dataset:
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of insulin may be necessary.
B ala konsegwenza ta ’ zjieda fis - sensittività g all- insulina, pazjenti li jir ievu pioglitazone f’ kura doppja ma ’ l- insulina jistg u jkunu f’ riskju ta ’ ipogli emija relatata mad- do a, u jista ’ jkun me tie tnaqqis fid- do a ta ’ l- insulina.
A number of medicinal products are known to interact with the glucose metabolism.
Hemm numru ta ’ prodotti medi inali li huma mag rufa li g andhom effett fuq il- metaboli mu ta ’ glucose.
The following substances may reduce the patient’ s insulin requirements:
Dawn is- sustanzi li ejjin jistg u jnaqqsu l - ti ijiet tal- pazjent g all- insulina:
Oral antidiabetic drugs (OAD), octreotide, monoamine oxidase inhibitors (MAOIs), non-selective beta-adrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Medi ini kontra d- dijabete li jittie du mill - alq (OAD), octreotide, inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- ri etturi beta- adrener i i mhux selettivi, inibituri ta ’ l- enzima li tbiddel angiotensin (ACE), salicylates, alko ol, sterojdi anaboli i u sulphonamides.
The following substances may increase the patient’ s insulin requirements:
4 Dawn is- sustanzi li ejjin jistg u j idu l - ti ijiet tal- pazjent g all- insulina:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Kontra ettivi orali, thiazides, glukokortikojdi, ormoni tat- tirojde, simpatomimeti i u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Sustanzi li jimblukkaw ir- ri etturi beta jistg u jg attu s- sintomi ta ’ ipogli emija.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
L- alko ol jista ’ jintensifika u jtawwal l- effetti ipogli emi i ta ’ l- insulina.
4 4.6 Pregnancy and lactation
4. 6 Tqala u Treddig
There is limited clinical experience with NovoMix 30 in pregnancy.
M’ hemmx tag rif kliniku bi ejjed dwar l- u u ta ’ NovoMix 30 waqt it- tqala.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Studji fuq ir- riproduzzjoni ta ’ l- annimali ma velaw l- ebda differenzi bejn insulin aspart u l- insulina umana fir- rigward ta ’ l- embrijutossi ità jew it- terato eni ità.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
B’ mod enerali, il- kontroll intensifikat tal- glucose fid- demm u l- monitora ta ’ nisa tqal bid- dijabete huma rakkomandati matul it- tqala u meta t- tqala tkun qed ti i ppjanata.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Il - ti ijiet ta ’ l- insulina normalment jonqsu fl- ewwel trimestru u ji diedu sussegwentement matul it- tieni u t- tielet trimestri.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Wara l - las, il - ti ijiet ta ’ l- insulina jer g u lura malajr g al- livelli ta ’ qabel it- tqala.
There are no restrictions on treatment with NovoMix 30 during lactation.
M’ hemm l- ebda restrizzjonijiet fuq il- kura b’ NovoMix 30 matul it- treddig.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
Il- kura bl- insulina fl- omm li tkun qed tredda ’ ma to loq l- ebda riskju g at- tarbija.
However, the NovoMix 30 dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm b onn li d - do a ta ’ NovoMix 30 ikun a ustat.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il - ila biex issuq jew t addem magni.
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Il- pazjenti g andhom jing ataw parir sabiex jie du prekawzjonijiet biex jevitaw l- ipogli emija waqt is- sewqan.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Ir- reazzjonijiet avversi tal- medi ina osservati f’ pazjenti li kienu qed ju aw prodotti NovoMix huma fil- parti l- kbira dipendenti fuq id- do a u min abba l- effett farmakolo iku ta ’ l- insulina.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Kif ji ri ma ’ prodotti o rajn ta ’ insulina, eneralment l- effett mhux mixtieq li jse bl- aktar mod komuni hija l - ipogli emija.
It may occur if the insulin dose is too high in relation to the insulin requirement and therefore require special attention during dose intensification as outlined in section 4.2.
Din tista ’ sse jekk id- do a ta ’ l- insulina tkun g olja wisq meta mqabbla mal - tie a ta ’ l- insulina u g alhekk te tie attenzjoni spe jali matul l- intensifikazzjoni tad- do a kif spjegat fil- qosor f’ sezzjoni 4. 2.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Ipogli emija severa tista ’ twassal g al telfien mis- sensi u/ jew konvul jonijiet u tista ’ twassal g al indeboliment temporanju jew permanenti tal- funzjoni tal- mo jew sa ansitra g al mewt.
In clinical trials and during marketed use the frequency varies with patient population and dose regimens therefore no specific frequency can be presented.
Waqt studji klini i u matul l- u u tal- medi ina meta l- prodott tqieg ed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond l- iskeda tad- do a, u g alhekk l- ebda frekwenza spe ifika ma tista ’ ti i ppre entata.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Matul l- istudji klini i, ma kien hemm ebda differenza fl- ammont totali ta ’ ipogli emija f’ pazjenti kkurati b’ insulin aspart u f’ dawk ikkurati b’ insulina umana.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Minn studji klini i, il- frekwenzi tar- reazzjonijiet avversi tal- medi ina, li permezz ta ’ evalwazzjoni s i a huma kkunsidrati li huma konnessi ma ’ insulin aspart, huma mni lin hawn ta t.
The frequencies are defined as:
Il- frekwenzi huma mfissra b ala:
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
Mhux komuni (> 1/ 1, 000, < 1/ 100) u rari (> 1/ 10, 000, < 1/ 1, 000).
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Ka ijiet spontanji i olati huma ppre entati b ala rari afna u definiti b ala (< 1/ 10, 000), li jinkludi rapporti i olati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
5 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa g andhom jitni lu skond is- serjetà tag hom.
Immune system disorders Uncommon - Urticaria, rash, eruptions
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx, eruzzjonijiet
Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjoni u tnaqqis fil- pressjoni tad- demm.
Generalised hypersensitivity reactions are potentially life threatening.
Ir- reazzjonijiet ta ’ sensittività e essiva eneralizzata huma potenzjalment ta ’ periklu g all - ajja.
5 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Disturbi fis- sistema nervu a Rari - Newropatija periferali Titjib mg a el fil- kontroll ta ’ glucose fid- demm jista ’ jkun asso jat ma ’ kundizzjoni msej a newropatija akuta bl- u ig, li s- soltu tkun riversibbli.
Eye disorders Uncommon - Refraction disorder Refraction anomalies may occur upon initiation of insulin therapy.
Disturbi fl- g ajnejn Mhux komuni - Disturbi fir- rifrazzjoni Anomaliji tar- rifrazzjoni jistg u jse u mal- bidu tat- terapija bl- insulina.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Mhux komuni - Retinopatija dijabetika Titjib fil- kontroll gli emiku fit- tul inaqqas ir- riskju tal- progressjoni tar- retinopatija dijabetika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Madankollu, l- intensifikazzjoni tat- terapija bl- insulina b’ titjib f’ daqqa fil- kontroll gli emiku tista ’ tkun asso jata ma ’ retinopatija dijabetika li tmur g all- ag ar.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Disturbi fil - ilda u fit- tessuti ta ’ ta t il - ilda Mhux komuni - Lipodistrofija Il- lipodistrofija tista ’ sse fis- sit ta ’ l- injezzjoni b ala konsegwenza li wie ed ma jibdilx is- siti ta ’ l - injezzjoni f ’ ona partikolari.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Mhux komuni - Sensittività e essiva lokali Reazzjonijiet ta ’ sensittività e essiva lokali (mura, nef a u akk fis- sit ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
These reactions are usually transitory and normally they disappear during continued treatment.
Dawn ir- reazzjonijiet normalment ikunu temporanji u s- soltu jisparixxu matul it- tkomplija tal- kura.
General disorders and administration site conditions Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Disturbi enerali u kundizzjonijiet ta ’ mnejn jing ata Mhux komuni - Edima L- edima tista ’ sse fil- bidu tat- terapija bl- insulina.
Oedema and weight increase may occur when NovoMix 30 is used in combination with OADs.
Jista ’ jkollok edima u jieda fil- pi meta NovoMix 30 jintu a flimkien ma ’ l- OADs
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Do a e essiva spe ifika g all- insulina ma tistax ti i definita, madankollu, l- ipogli emija tista ’ ti viluppa fuq firxa ta ’ stadji sekwenzjali jekk jing ataw do i qawwijin i ejjed meta mqabbla mal - ti ijiet tal- pazjent:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Episodji fief ipogli emi i jistg u jkunu kkurati bl- g oti mill - alq ta ’ prodotti ta ’ glucose jew li fihom iz- zokkor.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
G alhekk hu rakkomandat li l- pazjent dijabetiku dejjem i omm fuqu prodotti li jkun fihom iz- zokkor. • Episodji ipogli emi i serji, meta l- pazjent ikun intilef minn sensih, jistg u jkunu kkurati bi glucagon (0. 5 sa 1 mg) mog ti ol- muskoli jew ta t il - ilda minn persuna m arr a, jew bi glucose li jing ata ol- vini minn persuna medika professjonali.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Glucose g andu wkoll jing ata minn ol- vini jekk il- pazjent ma jirrispondix g al glucagon fi mien 10 sa 15- il minuta.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jer a ’ ji i f’ sensih, hu rrakkomandat li l- pazjent jing ata karboidrati mill - alq sabiex tkun
Drugs used in diabetes.
Medi ini li jintu aw fid- dijabete.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Insulini u analogi g all- injezzjoni,, li ja dmu b’ mod intermedju m alltin ma ’ dawk li ja dmu malajr.
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 30 hu suspensjoni bifa ika ta ’ insulin aspart (analogu ta ’ l- insulina umana li ja dem malajr) u insulin aspart ikkristallizzat bi protamine (analogu ta ’ l- insulina umana li ja dem b’ mod intermedju).
6 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
L- effett ta ’ l- insulina li jbaxxi l- glucose fid- demm ise meta l- molekuli jing aqdu mar- ri etturi ta ’ l - insulina fuq i - elluli tal- muskoli u tax- xa am u b’ hekk jiffa ilitaw id- d ul ta ’ glucose u fl- istess in jinibixxu l- produzzjoni ta ’ glucose mill- fwied.
NovoMix 30 is a biphasic insulin, which contains 30% soluble insulin aspart.
NovoMix 30 hu insulina bifa ika li fiha 30% insulin aspart li jin all.
This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Dan jibda ja dem malajr u g alhekk jista ’ jing ata iktar vi in l- ikel (minn ero sa 10 minuti mill- ikla) meta mqabbel ma ’ l - insulina umana li tin all.
The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin (Figure 1).
Il- fa i kristallina (70%) tikkonsisti f’ insulin aspart ikkristallizzat bi protamine, li g andu profil ta ’ attività li jixbah lil dak ta ’ l- insulina NPH umana (Figura 1).
When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Meta NovoMix 30 ikun injettat minn ta t il - ilda, jibda ja dem fi mien 10 sa 20 minuta mill - injezzjoni.
The maximum effect is exerted between 1 and 4 hours after injection.
L- effett massimu jse bejn 1 u 4 sig at wara l- injezzjoni.
The duration of action is up to 24 hours.
L- azzjoni ddum sa 24 sieg a.
Glucose infusion rate
Rata ta ’ l - infu joni ta ’ glucose
Hours
Sig at
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
Profil ta ’ l- attività ta ’ NovoMix 30 (___) u l- insulina umana bifa ika 30 (---) f’ su b’ sa ithom.
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.
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 bifa ika 30.
Insulin aspart is equipotent to human insulin on a molar basis.
Insulin aspart hu ekwipotenti g all- insulina umana fuq ba i molari.
Compared to biphasic human insulin 30, administration of NovoMix 30 before breakfast and dinner resulted in lower postprandial blood glucose after both meals (breakfast and dinner).
Meta mqabbel ma ’ l- insulina umana bifa ika 30, l - g oti ta ’ NovoMix 30 qabel il- kolazzjon u l- pranzu irri ulta f’ livell aktar baxx ta ’ glucose fid- demm wara - ew ikliet (kolazzjon u pranzu).
A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting blood glucose was higher in patients treated with NovoMix 30, than in patients treated with biphasic human insulin 30.
Meta- anali i li kienet tinkludi disa ’ studji klini i b’ pazjenti bid- dijabete tat- tip 1 u 2 uriet li l- livell tal - glucose fid- demm waqt is- sawm kien og la f’ pazjenti kkurati b’ NovoMix 30 milli f’ pazjenti kkurati b’ insulina umana bifa ika 30.
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
Fi studju wie ed, 341 pazjent bid- dijabete ta ’ tip 2 kienu mag ula b’ mod ka wali g al kura jew b’ NovoMix 30 wa du jew b’ NovoMix 30 flimkien ma ’ metformin, jew b’ metformin flimkien ma ’
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.
Il- varjabbli primarju ta ’ l- effika ja - HbA1c wara 16- il img a ta ’ kura - ma kienx differenti bejn pazjenti b’ NovoMix 30 flimkien ma ’ metformin u pazjenti b’ metformin flimkien ma ’ sulfonylurea.
In this trial 57% of the patients had baseline HbA1c above 9%; in these patients treatment with NovoMix 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
F’ dan l- istudju, 57% tal- pazjenti kellhom linja ba i HbA1c ta ’ iktar minn 9%; f’ dawn il - pazjenti, kien hemm iktar tnaqqis b’ mod sinifikanti fl - HbA1c permezz tal- kura ta ’ NovoMix 30 flimkien ma ’ metformin milli bil- kura ta ’ metformin flimkien ma ’ sulfonylurea.
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).
Fi studju wie ed, pazjenti bid- dijabete ta ’ tip 2, li ma kienux ikkontrollati b’ mod suffi jenti permezz ta ’ medi ini orali ipogli emi i wa idhom, kienu mag ula b’ mod ka wali g al kura jew b’ NovoMix 30 darbtejn kuljum (117- il pazjent) jew b’ insulin glargine darba kuljum (116- il pazjent).
After 28 weeks treatment following the dosing guideline outlined in section 4.2, the mean reduction in HbA1c was 2.8% with NovoMix 30 (mean at baseline = 9.7%).
Wara 28 img a ta ’ kura fuq il- linja gwida tad- do a spjegat fil- qosor f’ sezzjoni 4. 2, il- medja tat- tnaqqis fl - HbA1c kienet ta ’ 2. 8% b’ NovoMix 30 (medja fil- linja ba i = 9. 7%).
With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/ L (from 14.0 mmol/ L at baseline to 7.1 mmol/ L).
B’ NovoMix 30, 66% u 42% tal - pazjenti la qu livelli HbA1c ta t 7% u 6. 5%, rispettivament, u l- medja ta ’ FPG tnaqqset b’ madwar 7 mmol/ L (minn linja ba i ta ’ 14. 0 mmol/ l g al 7. 1 mmol/ l).
7 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.
F’ pazjenti bid- dijabete tat- tip 2, meta- anali i wriet tnaqqis fin- numru totali ta ’ riskju ta ’ episodji ipogli emi i ta ’ matul il- lejl u ta ’ ipogli emija ma uri b’ NovoMix 30 meta mqabbla ma ’ insulina umana bifa ika 30.
The risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix 30
Kien hemm riskju og la fin- numru totali ta ’ episodji ipogli emi i ta ’ matul il- jum f’ pazjenti kkurati b’ NovoMix 30.
A 16-week clinical trial comparing postprandial glycaemic control of meal- related NovoMix 30 with meal-related human insulin/ biphasic human insulin 30 and bedtime NPH insulin was performed in 167 subjects aged 10 to 18 years.
Studju kliniku li ie mag mul f’ 167 su ett ta ’ età bejn 10 u 18- il sena u li dam 16- il img a, qabbel il- kontroll gli emiku ta ’ wara l- ikel ta ’ NovoMix 30 mog ti mal - in ta ’ l- ikel ma ’ l- insulina umana / insulina umana 30 bifa ika mog tija mal - in ta’ l- ikel u NPH mog ti mal - in ta ’ l- irqad.
Mean HbA1c remained similar to baseline throughout the trial in both treatment groups, and there was no difference in hypoglycaemia rate with NovoMix 30 or biphasic human insulin 30.
Matul l- istudju kollu, il- livell medju ta ’ l - HbA1c baqa ’ simili g al dak tal- linja ba i fi - ew gruppi ta t kura u ma kien hemm ebda differenza fir- rata ta ’ ipogli emija kemm b’ NovoMix 30 u kemm b’ insulina umana 30 bifa ika.
In a smaller (54 subjects) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycaemic episodes and the postprandial glucose increase was significantly lower with NovoMix 30 compared to biphasic human insulin 30.
F’ popolazzjoni i ken (54 su ett) u ta ’ età i g ar (etajiet bejn 6 u 12- il sena), ikkurati f’ studju double - blind u cross- over (12- il img a fuq kull kura), ir- rata ta ’ episodji ipogli emi i u - ieda taz- zokkor fid- demm wara l- ikel kienu b’ mod sinifikanti inqas b’ NovoMix 30 meta mqabbla ma ’ insulina umana 30 bifa ika.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Il- livell finali ta ’ HbA1c kien b’ mod sinifikanti inqas fil- grupp ikkurat b’ insulina umana 30 bifa ika meta mqabbel ma ’ dak ikkurat b’ NovoMix 30.
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 30, as compared with soluble human insulin.
F’ insulina aspart, is- sostituzzjoni ta ’ l- a idu amminiku proline b’ aspartic acid f’ po izzjoni B28 tnaqqas it- tendenza li jiffurmaw e ameri fil- porzjon li jin all ta ’ NovoMix 30, meta mqabbel ma ’ l - insulina umana li tin all.
The insulin aspart in the soluble phase of NovoMix 30 comprises 30% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
L- insulin aspart fil- fa i li tin all ta ’ NovoMix 30, jinkludi 30% ta ’ l- insulina totali; dan ji i assorbit iktar malajr mill- istrat sottokutanju meta mqabbel mal- komponent ta ’ l- insulina bifa ika li tin all.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Is- 70% li jibqa ’ jkun f’ sura kristallina b ala insulin aspart ikkristallizzat bi protamine; dan g andu profil ta ’ assorbiment imtawwal li jixbah lil dak ta ’ l- insulina NPH umana
The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Il- kon entrazzjoni massima ta ’ insulina fis- serum hi, b ala medja, 50% og la b’ NovoMix 30 milli bl - insulina umana bifa ika 30.
The time to maximum concentration is, on average, half of that for biphasic human insulin 30.
Il - in g all- kon entrazzjoni massima hu, b ala medja, nofs il - in me tie g all- insulina umana bifa ika 30.
In healthy volunteers a mean maximum serum concentration of 140 ± 32 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.20 U/ kg body weight.
F’ voluntiera b’ sa ithom il- medja tal- kon entrazzjoni massima fis - serum ta ’ 140 ±32 pmol/ l intla qet madwar 60 minuta wara li ng atat do a ta t il - ilda ta ’ 0. 20 U/ kg ta ’ pi tal - isem.
The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
Il- medja tal- half life (t½) ta ’ NovoMix 30, li tirrifletti r- rata ta ’ assorbiment tal - porzjon imwa al ma ’ protamine, kienet ta ’ madwar 8- 9 sig at.
Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Il- livelli ta ’ l- insulina fis- serum re g u lura g al- linja ba i 15- 18- il sieg a wara li ng atat do a ta t il - ilda.
In type 2 diabetic patients, the maximum concentration was reached about 95 minutes after dosing, and concentrations well above zero for not less than 14 hours post-dosing were measured.
F’ pazjenti bid- dijabete ta ’ tip 2, il- kon entrazzjoni massima ntla qet madwar 95 minuta wara li ng atat id- do a, u kon entrazzjonijiet ’ il fuq sewwa minn ero g al mhux inqas minn 14- il sieg a wara li ng atat id- do a ew imkejla.
The pharmacokinetics of NovoMix 30 has not been investigated in children or adolescents.
Il- farmakokinetika ta ’ NovoMix 30 ma ietx investigata la fit- tfal u lanqas fl - adolexxenti.
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6– 12 years) and adolescents (13– 17 years) with type 1 diabetes.
Madankollu, il- karatteristi i farmakokineti i u farmakodinami i ta ’ insulin aspart li jin all ew investigati fit- tfal (6- 12- il sena) u fl- adolexxenti (13- 17- il sena) bid- dijabete tat- tip 1.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Insulin aspart ie assorbit b’ mod malajr fi - ew gruppi ta ’ etajiet, b’ tmax simili g al dak ta ’ l- adulti.
However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Madankollu, kien hemm differenzi fis- Cmax bejn i - ew gruppi, li jenfasizza l- importanza ta ’ do a individwali meta jing ata insulin aspart.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
8 Il- farmakokinetika ta ’ NovoMix 30 ma ietx investigata fl- anzjani jew f’ pazjenti b’ indeboliment fil - funzjoni tal- kliewi jew tal- fwied.
Non-clinical data with insulin aspart reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Informazzjoni li mhiex klinika b’ insulin aspart, mag mula fuq studji konvenzjonali ta ’ sigurtà farmakolo ika, effett tossiku minn do i ripetuti, effett tossiku fuq il - eni, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu spe jali g all- bnedmin
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Fi studji in vitro, il- mod kif ja ixxi insulin aspart, inklu il- mod kif jing aqad mas- siti tar- ri etturi ta ’ l- insulina u ta ’ IGF- 1 u l- effetti fuq it- tkabbir ta - elluli, jixba afna lil dak ta ’ insulina umana.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
L - istudji juru wkoll li d- disso jazzjoni mill- g aqda minn mar- ri ettur ta ’ l- insulina ta ’ insulin aspart hu ekwivalenti g al dak ta ’ l- insulina umana.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc (b ala chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (g all- a ustament fil- pH) Hydrochloric acid (g all- a ustament fil- pH Ilma g all- injezzjonijiet
The in-use shelf life is 4 weeks (not above 30°C).
Waqt l- u u, i - mien kemm idum tajjeb hu ta ’ 4 img at (f’ temperatura mhux iktar minn 30°C).
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
(2°C – 8°C) ’ il bog od mill- kompartiment tal- fri a.
NovoMix 30 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Skarto i NovoMix 30 Penfill waqt l- u u jew li jin arru g al li jista ’ jinqala ’: jistg u jin ammu fit - temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
Keep the cartridges in the outer carton in order to protect from light.
Ta inx f’ temperatura ’ l fuq minn 30°C. omm l- iskarto i fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to allow NovoMix 30 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 30 Penfill mill- fri, huwa rakkomandat li t alli NovoMix 30 Penfill jil aq it- temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina, kif spjegat meta tu ah g all- ewwel darba.
6.5 Nature and contents of container
9 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
The cartridge contains a glass ball to facilitate resuspension.
Skarto tal - ie (Tip 1) mag luq b’ pistun tal- gomma ming ajr latti e (bromobutyl) f’ tarf wie ed, u g eluq tal- gomma ming ajr latti e (bromobutyl/ polyisoprene) fit- tarf l- ie or L- iskarto fih bo a tal - ie biex tg in biex ter a ’ ti i mag mula s- suspensjoni.
Each cartridge contains 3 ml suspension.
Kull skarto fih 3 ml ta ’ suspensjoni.
Cartons of 5 or 10 cartridges.
Kaxxi tal- kartun ta ’ 5 jew 10 skarto i.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g al skop kummer jali.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
L- iskarto i huma mag mula biex jintu aw mas- sistemi ta ’ l- g oti Novo Nordisk (strumenti li jservu fit- tul g al u u ripetut) u labar NovoFine.
Detailed instruction accompanying the cartridge and delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkumpanjaw l- iskarto u s - sistema ta ’ l- g oti g andhom ikunu segwiti.
NovoMix 30 Penfill is for use by one person only.
NovoMix 30 Penfill hu g al u u minn persuna wa da biss.
The cartridge must not be refilled.
m’ g andux jimtela mill - did.
9 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Il - tie a li ter a ’ tifforma suspensjoni mill - did ta ’ NovoMix 30 immedjatament qabel l- u u g andha ti i enfasizzata lill- pazjent.
The resuspended liquid must appear uniformly white and cloudy.
Il- likwidu li jkun ifforma suspensjoni mill - did g andu jidher abjad u qisu alib b’ mod uniformi.
NovoMix 30 which has been frozen must not be used.
NovoMix 30 li kien iffri at m’ g andux jintu a.
The patient should be advised to discard the needle after each injection.
Il- pazjent g andu jing ata parir biex jarmi l- labra wara kull injezzjoni.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intu a jew skart li jibqa wara l- u u tal- prodott g andu jintrema kif jitolbu l- li ijiet lokali.
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
1 August 2000 Date of last renewal:
1 ta’ Awwissu 2000 Data ta ’ l- a ar ti did:
1 August 2005
1 ta’ Awwissu 2005
NovoMix 50 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 50 Penfill 100 U/ ml, suspensjoni g all- injezzjoni fi skarto.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 50/ 50
Insulin aspart * li jin all / insulin aspart * ikkristallizzat bi protamine ……... 100 U/ ml fi proporzjon ta ’ 50/ 50
NovoMix 50 is a white suspension.
NovoMix 50 hu suspensjoni bajda.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 50 to be given immediately before a meal.
Il- fatt li insulin aspart jibda ja dem malajr u jil aq il- massimu ta ’ l- attività tieg u kmieni jippermetti li NovoMix 50 jing ata immedjatament qabel ikla.
When necessary, NovoMix 50 can be given soon after start of a meal.
Meta jkun me tie, NovoMix 50 jista ’ jing ata dritt wara li tkun bdejt tiekol.
Dosage:
Do a:
Dosage of NovoMix 50 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Id- do a ta ’ NovoMix 50 hu individwali u hu stabbilit fuq il- ba i tal- parir tat- tabib skond il - ti ijiet tal- pazjent.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 50.
F’ pazjenti adulti, il - tie a individwali ta ’ l- insulina normalment hi ta ’ bejn 0. 5 u 1. 0 Unitajiet/ kg/ kuljum u dan jista ’ ji i pprovdut b’ mod s i jew b’ mod parzjali b’ NovoMix 50.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. due to obesity), and lower in patients with residual endogenous insulin production.
Il - tie a ta ’ l- insulina ta ’ kuljum tista ’ tkun og la f’ pazjenti b’ re istenza g all- insulina (e. min abba l - obe ità), u iktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endo enika.
In patients with type 2 diabetes, NovoMix 50 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
F’ pazjenti b’ dijabete ta ’ tip 2, NovoMix 50 jista ’ jing ata f’ monoterapija jew flimkien ma ’ metformin, meta l- glucose fid - demm ikun ikkontrollat b’ mod inadegwat b’ metformin wa du.
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
It- trasferiment g al NovoMix 50 minn preparazzjonijiet o rajn ta ’ l- insulina jista ’ jkollu b onn ta ’ a ustament fid- do a u fil - in ta ’ l- g oti.
As with all insulins, close glucose monitoring is recommended during transition and the initial weeks thereafter (see section 4.4).
B all- insulini l- o rajn kollha, hu rakkomandat li l- glucose ikun immonitorjat mill- qrib waqt it- transizzjoni u fl- ewwel img at su essivi (ara sezzjoni 4. 4).
Adjustment of dosage may also be necessary if patients change their diet.
L- a ustament fid- do a jista ’ jkun ne essarju wkoll jekk il- pazjenti jibdlu d- dieta tag hom.
Physical activity may reduce the patients’ insulin requirements.
L - attività fi ika tista ’ tnaqqas il - ti ijiet ta ’ l- insulina tal- pazjent:
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
F’ pazjenti bid- dijabete mellitus, kontroll metaboliku mill- a jar effettivament jittardja l- bidu u jnaqqas il- progressjoni ta ’ komplikazzjonijiet dijabeti i li jkun hemm iktar tard fil- marda.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
L- a jar kontroll
11 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
B all- insulini l- o rajn kollha, f’ pazjenti anzjani u f’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi, il- monitora tal- glucose g andu jkun intensifikat, u d- do a a ustat fuq ba i individwali.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
L - indeboliment fil- kliewi jew fil- fwied jista ’ jnaqqas il - ti ijiet tal- pazjent g all- insulina.
No studies have been performed with NovoMix 50 in children and adolescents under the age of 18 years.
Ma sar l- ebda studju b’ NovoMix 50 fit- tfal u fl- adoloxxenti ta ’ ta t it- 18- il sena.
Administration:
Kif Jing ata:
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 50 jing ata minn ta t il - ilda fil- koxxa jew fil - ajt addominali.
If convenient, the gluteal or deltoid region may be used.
Jekk ikun konvenjenti, jistg u jintu aw i - oni gluteali jew tad- deltojd. ewwa l- istess ona g andek tvarja s- siti fejn ting ata l- injezzjoni.
As with all types of insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
B all- insulini kollha, it- tul ta ’ l- azzjoni ser ivarja skond id- do a, is- sit minn fejn ting ata l- injezzjoni, il- fluss tad- demm, it- temperatura u l- livell ta ’ l- attività fi ika.
The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
L- effett ta ’ siti differenti ta ’ l- injezzjoni fuq l- assorbiment ta ’ NovoMix 50 ma kienx investigat.
NovoMix 50 should never be administered intravenously.
NovoMix 50 m’ g andu qatt jing ata minn ol- vini.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
L- u u ta ’ do i li huma inadegwati jew it- twaqqif tal- kura, spe jalment f’ pazjenti dijabeti i li huma dipendenti fuq l- insulina, jista ’ jwassal g al ipergli emija u ketoa idosi dijabetika; kundizzjonijiet li potenzjalment huma letali.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
Li taqbe ikla jew li tag mel e er izzju fi iku li je tie sforz qawwi, jista ’ jwassal g al ipogli emija (ara sezzjoni 4. 8 u sezzjoni 4. 9).
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Dawk il- pazjenti, li l- kontroll taz- zokkor fid- demm tag hom jitjieb bil- kbir, e. permezz ta ’ terapija intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tag hom ta ’ l - ipogli emija, u g andhom jing ataw parir dwar dan il- fatt.
NovoMix 50 should be administered in immediate relation to a meal.
NovoMix 50 g andu jing ata b’ rabta immedjata ma ’ l- ikel.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Meta l- pazjenti jkunu ttrasferiti bejn tipi differenti ta ’ prodotti ta ’ l- insulina, is- sintomi bikrija ta ’ twissija ta ’ ipogli emija jistg u jinbidlu jew isiru inqas prominenti minn dawk li kien ikollhom bl - insulina pre edenti.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue), and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Tibdil fil- qawwa, marka (manifattur), tip, ori ini (mill- annimali, mill- bniedem, minn analogu ta ’ l- insulina umana) u/ jew fil- metodu ta ’ manifattura (DNA rikombinanti kontra insulina li ejja mill - annimali) jista ’ jirri ulta fil - tie a ta ’ tibdil fid- do a.
Patients taking NovoMix 50 may need a change in dosage from that used with their usual insulin.
Jista ’ jkun li pazjenti li jkunu qed jie du NovoMix 50 ikollhom b onn ta ’ bidla fid- do a minn dak u at ma ’ l- insulina normali tag hom ta ’ qabel.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Jekk ikun me tie xi a ustament fid- do a, dan jista ’ jsir ma ’ l- ewwel do a jew matul l - ewwel ftit img at jew xhur.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Li fl- istess ona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jg in biex inaqqas jew jimpedixxi dawn ir - reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
Reactions usually resolve in a few days to a few weeks.
F’ okka jonijiet
On rare occasions, injection site reactions may require discontinuation of NovoMix 50.
12 rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni jista ’ jkun hemm il- b onn li NovoMix 50 jitwaqqaf
12 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
Oral antidiabetic drugs (OAD), octreotide, monoamine oxidase inhibitors (MAOIs), non-selective beta-adrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Medi ini kontra d- dijabete li jittie du mill - alq (OHD), octreotide, inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- ri etturi beta- adrener i i mhux selettivi, inibituri ta ’ l- enzima li tbiddel angiotensin (ACE), salicylates, alko ol, sterojdi anaboli i u sulphonamides.
The following substances may increase the patient’ s insulin requirements:
Dawn is- sustanzi li ejjin jistg u j idu l - ti ijiet tal- pazjent g all- insulina:
There is limited clinical experience with NovoMix 50 in pregnancy.
M’ hemmx tag rif kliniku bi ejjed dwar l- u u ta ’ NovoMix 50 waqt it- tqala.
There are no restrictions on treatment with NovoMix 50 during lactation.
M’ hemm l- ebda restrizzjonijiet fuq il- kura b’ NovoMix 50 matul it- treddig.
However, the NovoMix 50 dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm b onn li d - do a ta ’ NovoMix 50 ikun a ustat.
In clinical trials and during marketed use the frequency varies with patient population and dose
Din tista ’ sse jekk id- do a ta ’ l- insulina tkun g olja wisq meta mqabbla mal - tie a ta ’
13 regimens therefore no specific frequency can be presented.
Ipogli emija severa tista ’ twassal g al telfien mis- sensi u/ jew konvul jonijiet u tista ’ twassal g al indeboliment temporanju jew permanenti tal- funzjoni tal- mo jew sa ansitra g al mewt.
The frequencies are defined as:
Il- frekwenzi huma definiti b ala:
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Ka ijiet spontanji i olati huma ppre entati b ala rari afna u definiti b ala (< 1/ 10, 000) li jinkludu rapporti i olati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa g andhom jitni lu skond is- serjetà tag hom.
Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Disturbi fis- sistema nervu a Rari - Newropatija periferali Titjib mg a el fil- kontroll ta ’ glucose fid- demm jista ’ jkun asso jat ma ’ kundizzjoni msej a newropatija akuta bl- u ig, li s- soltu tkun riversibbli.
4.9 Overdose
14 4. 9 Do a e essiva
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Episodji fief ipogli emi i jistg u jkunu kkurati bl- g oti mill - alq ta ’ prodotti tal- glucose jew prodotti li fihom iz- zokkor.
14 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
G alhekk hu rakkomandat li l- pazjent dijabetiku dejjem i omm fuqu prodotti li jkun fihom iz- zokkor. • Episodji ipogli emi i serji, meta l- pazjent ikun intilef minn sensih, jistg u jkunu kkurati bi glucagon (0. 5 sa 1 mg) mog ti ol- muskoli jew ta t il - ilda minn persuna m arr a, jew bi glucose li jing ata minn ol- vini minn persuna medika professjonali.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jer a ’ ji i f’ sensih, hu rrakkomandat li l- pazjent jing ata karboidrati mill - alq sabiex tkun evitata rikaduta.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Insulini u analogi g all- injezzjoni, li ja dmu b’ mod intermedju m alltin ma ’ dawk li ja dmu malajr.
NovoMix 50 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 50 hu suspensjoni bifa ika ta ’ insulin aspart (analogu ta ’ l- insulina umana li ja dem malajr) u insulin aspart ikkristallizzat bi protamine (analogu ta ’ l- insulina umana li ja dem b’ mod intermedju).
The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
L- effett ta ’ l- insulina li jbaxxi l- glucose fid- demm ise meta l- molekuli jing aqdu mar- ri etturi ta ’ l - insulina fuq i - elluli tal- muskoli u tax- xa am u b’ hekk jiffa ilitaw id- d ul ta ’ glucose u fl- istess in jinibixxu l- produzzjoni ta ’ glucose mill- fwied.
NovoMix 50 is a biphasic insulin, which contains 50% soluble insulin aspart.
NovoMix 50 hu insulina bifa ika li fiha 50% insulin aspart li jin all.
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Il- fa i kristallina (50%) tikkonsisti f’ insulin aspart ikkristallizzat bi protamine, li g andu profil ta ’ attività li jixbah lil dak ta ’ l- insulina NPH umana.
When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Meta NovoMix 50 ikun injettat minn ta t il - ilda, jibda ja dem fi mien 10 sa 20 minuta mill - injezzjoni.
The duration of action is up to 14 hours to 24 hours (Figure 1).
(Figura 1).
Glucose Infusion Rate
15 Rata ta ’ l- infu joni ta ’ Glucose
Hours NovoMix 50
Sig at NovoMix 50
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
Il- Profil ta ’ l- Attività g al NovoMix 50 f’ Pazjenti Kawkasi b’ Sa ithom
15 5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 50, as compared with soluble human insulin.
F’ insulina aspart, is- sostituzzjoni ta ’ l- a idu amminiku proline b’ aspartic acid f’ po izzjoni B28 tnaqqas it- tendenza li jiffurmaw e ameri fil- porzjon li jin all ta ’ NovoMix 50, meta mqabbel ma ’ l - insulina umana li tin all.
The insulin aspart in the soluble phase of NovoMix 50 comprises 50% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
L- insulin aspart fil- fa i li jin all ta ’ NovoMix 50, jinkludi 50% ta ’ l- insulina totali; dan ji i assorbit iktar malajr mill- istrat sottokutanju meta mqabbel mal- komponent ta ’ l- insulina bifa ika li tin all.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Il- 50% li jibqa ’ jkun f’ sura kristallina b ala insulin aspart ikkristallizzat bi protamine; dan g andu profil ta ’ assorbiment imtawwal li jixbah lil dak ta ’ l- insulina NPH umana.
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 U/ kg body weight.
F’ voluntiera b’ sa ithom, il- medja tal- kon entrazzjoni massima fis- serum ta ’ 445 ± 135 pmol/ l intla qet madwar 60 minuta wara li ng atat do a ta t il - ilda ta ’ 0. 30 U/ kg ta ’ pi tal - isem.
In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
F’ pazjenti bid- dijabete ta ’ tip 2, il- kon entrazzjoni massima ntla qet madwar 95 minuta wara li ng atat id- do a.
The pharmacokinetics of NovoMix 50 has not been investigated in elderly, children or patients with impaired renal or liver function.
Il- farmakokinetika ta ’ NovoMix 50 ma ietx investigata fl- anzjani, fit- tfal jew f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi jew tal- fwied.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc (b ala chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (g all- a ustament fil- pH Hydrochloric acid (g all- a ustament fil- pH Ilma g all- injezzjonijiet
16 NovoMix 50 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Skarto i NovoMix 50 Penfill waqt l- u u jew li jin arru g al li jista jinqala ’: jistg u jin ammu fit - temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to allow NovoMix 50 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 50 Penfill mill- fri, hu rakkomandat li t alli NovoMix 50 Penfill jil aq it - temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina kif hemm fl - istruzzjonijiet g all- ewwel u u.