NovoMix 30 FlexPen Insulin Aspart 30 Injection

1. Indications and Usage
Diabetes Mellitus: Treatment of adult and pediatric patients (typically ≥10 years) with diabetes mellitus who require insulin for the regulation of hyperglycemia.
2. Dosage and Administration
Dosage: Individualized based on blood glucose monitoring, clinical response, and dietary habits.
Administration: Subcutaneous injection only. Never for intravenous infusion or continuous subcutaneous insulin infusion (CSII).
Timing: Administer immediately before a meal. If necessary, can be administered shortly after the meal.
Injection Sites: Abdomen, thigh, buttocks, or upper arm. Sites must be rotated to prevent lipodystrophy.
Reconstitution: Gently roll or invert the pen between hands before each injection to ensure a uniform suspension.
3. Mechanism of Action
Dual-Action: Combines 30% soluble aspart for immediate postprandial control and 70% protamine-crystallized aspart for delayed absorption and basal coverage.
Pharmacokinetics: Onset within 10-20 minutes; biphasic peak effect (early and late); duration of action up to 24 hours.
4. Safety and Warnings
Hypoglycemia: The most common adverse reaction; risk increases with stricter glycemic control, missed meals, or excessive exercise.
Hypersensitivity: Severe allergic reactions, including anaphylaxis, may occur.
Hypokalemia: Insulin therapy may cause a shift of potassium into cells, leading to lower serum potassium levels.
Transitions: Dose adjustments may be required when switching between insulin brands or types.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Hypoglycemia, injection site reactions, lipodystrophy, and weight gain.
Clinical Research: Clinical trials demonstrate superior control of postprandial glucose compared to biphasic human insulin.
6. Drug Interactions
Agents Increasing Glucose: Corticosteroids, oral contraceptives, thyroid hormones, and sympathomimetics may increase insulin requirements.
Agents Decreasing Glucose: Oral antidiabetic drugs, ACE inhibitors, salicylates, and alcohol may potentiate hypoglycemic effects.
Beta-Blockers: May mask clinical signs of hypoglycemia (e.g., tachycardia and tremors).
7. Pharmaceutical Information
Active Ingredient: 30% soluble aspart and 70% protamine-crystallized aspart.
Excipients: Metacresol, glycerin, dibasic sodium phosphate, zinc oxide, protamine, and water for injection.
Appearance: White, cloudy suspension.
Storage: Unopened pens should be refrigerated (2°C to 8°C). In-use pens may be kept at room temperature (below 30°C) for up to 28 days.