Europe — EMA
Humulin M3 (Mixture 3)
Humulin M3 (Mixture 3) is a recombinant human insulin for subcutaneous use, indicated for type 1 and type 2 diabetes management in the EU.
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What is Insulin Human (Rdna)?
Humulin M3 (Mixture 3) is a recombinant human insulin (rDNA) product marketed in the European Union. It is supplied for subcutaneous injection and contains a fixed proportion of short‑acting and intermediate‑acting insulin molecules. The preparation is prescribed by health‑care professionals for the management of blood glucose in diabetes mellitus.
What is Insulin Human (Rdna) used for?
Humulin M3 is indicated for the control of hyperglycaemia in patients with diabetes mellitus when a mixed insulin regimen is appropriate. It may be used as part of a basal‑bolus strategy or in combination with oral antidiabetic agents.
- Type 1 diabetes mellitus requiring mealtime and background insulin coverage. - Type 2 diabetes mellitus inadequately controlled with diet, exercise, or oral agents. - Adults and children who benefit from a single injection providing both rapid and intermediate action. - Situations where a predictable insulin profile simplifies dosing schedules. - Adjunct therapy during periods of increased insulin demand, such as illness or stress.
What are the side effects of Insulin Human (Rdna)?
Adverse reactions to Humulin M3 can vary in frequency and severity.
Common: - Hypoglycaemia (low blood glucose) - Injection site redness, swelling or itching - Lipodystrophy (fat tissue changes at injection site) - Weight gain - Mild nausea
Serious: - Severe hypoglycaemia with loss of consciousness - Allergic reactions such as rash, urticaria or anaphylaxis - Edema (fluid retention) - Persistent hyperglycaemia indicating insulin resistance - Rare cases of insulin‑induced hypokalemia
What precautions apply to Insulin Human (Rdna)?
When prescribing Humulin M3, clinicians should consider several safety factors.
- Assess renal and hepatic function, as impairment may alter insulin clearance. - Monitor for signs of hypoglycaemia, especially in elderly or fasting patients. - Adjust doses during pregnancy, illness, or changes in physical activity. - Educate patients on proper injection technique to avoid lipohypertrophy. - Review concomitant medications that may mask hypoglycaemia symptoms. - Use caution in patients with a history of cardiovascular disease.
What does Insulin Human (Rdna) interact with?
Humulin M3 may interact with other drugs that affect glucose metabolism or insulin action.
Avoid: - Concurrent use of other insulin products without dose adjustment. - High‑dose beta‑blockers that can blunt hypoglycaemia warning signs. - MAO inhibitors that may potentiate insulin’s glucose‑lowering effect.
Use with caution: - Oral antidiabetic agents (e.g., sulfonylureas, meglitinides) that increase hypoglycaemia risk. - Corticosteroids, which can raise blood glucose and require dose changes. - Diuretics that may affect electrolyte balance and insulin sensitivity. - Alcohol, which can cause unpredictable glucose fluctuations.
Frequently asked questions
What is the composition of Humulin M3 (Mixture 3)?+
How is Humulin M3 administered?+
Can Humulin M3 be used in children with diabetes?+
What are the signs of hypoglycaemia while using Humulin M3?+
Should Humulin M3 be stored in the refrigerator?+
How does Humulin M3 differ from basal insulin only products?+
Is dose adjustment needed when starting Humulin M3?+
Can alcohol consumption affect Humulin M3 therapy?+
What should I do if I miss a dose of Humulin M3?+
Are there any special considerations for Humulin M3 during pregnancy?+
What monitoring is required while using Humulin M3?+
Can Humulin M3 be used together with oral diabetes medications?+
Product details
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