NovoMix 30 Penfill

Diabetes mellitus

Administer subcutaneously in the upper arm, thigh or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites.

Subcutaneous Diabetes Mellitus Combination rapid-onset (faster than regular insulin) and intermediate-acting insulins in fixed dose Typical daily insulin requirements range between 0.5-1 unit/kg Dose regimen varies among patients depending on metabolic needs; Administer SC q12hr (ie, before breakfast and evening meal); each dose intended to cover 2 meals or a meal and snack Dosing Considerations: Insulin naive patients: For patients with type 2 diabetes, the recommended starting dose of Insulin Aspart 30/70 is 6 Units at breakfast and 6 Units at dinner (evening meal). Insulin Aspart 30/70 can also be initiated once daily with 12 units at dinner (evening meal). How to intensify: Insulin Aspart 30/70 can be intensified from once daily to twice daily. When using Insulin Aspart 30/70 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. From Insulin Aspart 30/70 twice daily to thrice daily: If twice daily dosing with Insulin Aspart 30/70 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses. The dinner doses remain unchanged. How to adjust the dose: - Adjust the dose of Insulin Aspart 30/70 on the basis of the lowest pre-meal blood glucose level from the three previous days - Dose adjustment can be made once a week until target HbA1c is reached - The dose should not be increased if hypoglycemia occurred within three days - Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness The following titration guideline is recommended for dose adjustments: Pre-meal blood glucose level Dose adjustment < 4.4 mmol/l < 80 mg/dl - 2 units 4.4 – 6.1 mmol/l 80 – 110 mg/dl 0 6.2 – 7.8 mmol/l 111 – 140 mg/dl + 2 units 7.9 – 10 mmol/l 141 – 180 mg/dl + 4 units > 10 mmol/l > 180 mg/dl + 6 units

Safety and efficacy not established

Renal impairment: Dose adjustments may be needed.

Hypoglycaemia.Hypersensitivity to any of the components.

Insulin Aspart Biphasic is a biphasic suspension of soluble insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue). The blood glucose lowering effect of Insulin Aspart Biphasic is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Soluble insulin aspart which 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. The crystalline phase consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin. When Insulin Aspart Biphasic is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after injection. The duration of action is up to 24 hours.

Rapid changes in serum glucose may induce symptoms of hypoglycemia Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions (eg, long duration of diabetes, diabetic nerve disease, use of beta-blockers or intensified diabetes control) Caution in conditions with decreased insulin requirements (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment) Caution in conditions with increased insulin requirements (eg, fever, hyperthyroidism, trauma, infection, surgery) May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function because of risk for prolonged hypoglycemia

>10% Hypoglycemia (47-69%) Headache (12-35%) Influenza-like symptoms (12-13%) 1-10% Headache (9%) Dyspepsia (9%) Diarrhea (7-8%) Back pain (7%) Pharyngitis (6-7%) Frequency Not Defined Insulin resistance Lipodystrophy Lipohypertrophy Local allergic reaction Hypokalemia Weight gain Peripheral edema

Pregnancy (insulin requirements tend to fall during the 1st trimester, increase during the 2nd and 3rd) and lactation. Regular monitoring of HbA1c and blood glucose concentrations. Caution with increased insulin requirements: Fever, hyperthyroidism, trauma, infection, surgery Lactation: Unknown whether distributed in breast milk; compatible with breast feeding, but lactating women may require dosage adjustment; caution advised

Reduce insulin requirements w/ oral hypoglycemics, octreotide, MAOIs, nonselective ?-adrenergic blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids & sulfonamides; increase insulin requirements w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics & danazol. ?-blocking agents may mask the symptoms of hypoglycaemia. Alcohol may intensify & prolong the glucose lowering effect of insulin.