Mixtard® 30 FlexPen® 100 IU/mL Suspension for Injection

Product Overview

Mixtard® 30 FlexPen® is a pre-filled insulin pen containing a biphasic suspension of human insulin, comprising 30% soluble insulin and 70% isophane insulin. This combination offers both rapid onset and intermediate duration of action, making it suitable for managing blood glucose levels in individuals with diabetes mellitus.

Composition

• Active Substance: Human insulin (rDNA origin)

  • Soluble Insulin: 30%
  • Isophane Insulin: 70%

• Concentration: 100 international units (IU) per mL

• Formulation: Suspension for injection in a 3 mL pre-filled pen

Indications

Mixtard® 30 FlexPen® is indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged 10 years and above.

Dosage and Administration

• Dosage:

  • The dosage is individualized based on the patient's needs, typically ranging from 0.3 to 1.0 IU per kilogram of body weight per day. Regular monitoring of blood glucose levels is essential to determine the appropriate dose.

• Administration:

  • Route: Subcutaneous injection only; intravenous administration is contraindicated.

  • Injection Sites: Thigh, abdominal wall, gluteal region, or deltoid region. Rotate injection sites within the same region to reduce the risk of lipodystrophy.

  • Timing: Administer approximately 30 minutes before a meal.

  • Preparation: Before use, roll the pen between your hands and invert it to resuspend the insulin until it appears uniformly white and cloudy. Do not use if the suspension remains clear or contains clumps.

Device Features

• FlexPen®:
  • A pre-filled, color-coded pen designed for ease of use.
  • Delivers doses from 1 to 60 units in increments of 1 unit.
  • Compatible with NovoFine® or NovoTwist® disposable needles up to 8 mm in length.

Storage

• Unopened Pens:

  • Store in a refrigerator at 2°C to 8°C. Do not freeze. Keep away from direct light and heat.

• In-Use Pens:

  • Store at room temperature (below 30°C) for up to 6 weeks. Do not refrigerate. Keep the pen cap on when not in use to protect from light.

• General Precautions:

  • Keep out of reach of children.
  • Do not use after the expiration date.
  • Inspect the appearance of the insulin before use; only use if it appears uniformly white and cloudy after resuspension.

Precautions and Warnings

• Hypoglycemia: The most common adverse effect of insulin therapy. Monitor blood glucose regularly and be aware of the signs and symptoms of low blood sugar.

• Allergic Reactions: Seek immediate medical attention if you experience signs of a severe allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing.

• Medication Errors: Always check the insulin label before each injection to avoid mix-ups between different insulin products.

• Device Handling:

  • Do not share your FlexPen® with others, even if the needle is changed, to prevent cross-contamination.
  • Dispose of used needles safely in accordance with local regulations.

Note: This information is a summary and does not contain all possible details about Mixtard® 30 FlexPen®. Always consult your healthcare provider for personalized medical advice and read the accompanying patient information leaflet for comprehensive instructions.