Europe — EMA
Humulin M3
Humulin M3 is a 100 U/mL recombinant human insulin injection used for basal control of type 1 and type 2 diabetes in the EU.
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What is Insulin Human (Rdna)?
Humulin M3 is a recombinant human insulin (Insulin human) formulated as a 100 U/mL injectable solution for subcutaneous use. It is a prescription‑only antidiabetic agent marketed in the European Union and belongs to the insulin drug class. It provides basal insulin coverage and is used as part of a comprehensive diabetes management plan. The product is supplied in multi‑dose vials and is stored refrigerated until use.
What is Insulin Human (Rdna) used for?
Humulin M3 is indicated for the long‑term control of blood glucose in patients with diabetes mellitus.
- Adults with type 1 diabetes requiring basal insulin supplementation. - Adults with type 2 diabetes inadequately controlled on oral agents or other insulin regimens. - Pregnant women with pre‑existing diabetes when basal insulin is clinically appropriate (Category B). - Patients transitioning from other basal insulin formulations to a recombinant human insulin. - Use as part of a structured insulin therapy plan combined with mealtime rapid‑acting insulin.
What are the side effects of Insulin Human (Rdna)?
Like other basal insulins, Humulin M3 may be associated with adverse reactions that vary in frequency and severity.
Common: - Hypoglycemia, especially if meals are missed or dosing is excessive. - Injection‑site reactions such as redness, swelling, or bruising. - Lipodystrophy, including lipohypertrophy at repeated injection sites. - Weight gain associated with improved glycemic control.
Serious: - Severe hypoglycemia leading to loss of consciousness or seizures. - Allergic reactions ranging from urticaria to anaphylaxis. - Edema or heart failure exacerbation in susceptible individuals.
What precautions apply to Insulin Human (Rdna)?
Healthcare providers should consider several precautions before initiating Humulin M3 therapy.
- Assess renal and hepatic function, as impairment may alter insulin clearance. - Monitor blood glucose closely during periods of illness, stress, or changes in diet. - Adjust dose in pregnant or lactating women, keeping pregnancy category B in mind. - Avoid use in patients with known hypersensitivity to recombinant human insulin or any excipients. - Educate patients on proper injection technique to reduce lipodystrophy risk. - Consider cardiovascular status, as rapid glucose shifts can affect heart function. - Store the product refrigerated and discard after the indicated in‑use period.
What does Insulin Human (Rdna) interact with?
Humulin M3 can interact with other medicines, affecting glucose control or insulin action.
Avoid: - Concurrent use of other basal insulins or high‑dose insulin analogues without dose adjustment. - Beta‑blockers that may mask hypoglycemia symptoms. - Corticosteroids, which can increase insulin resistance and raise glucose levels. - Thiazide diuretics that may potentiate hypoglycemia.
Use with caution: - Oral antidiabetic agents (e.g., sulfonylureas, meglitinides) – monitor for additive hypoglycemia. - ACE inhibitors or ARBs – may enhance insulin sensitivity. - Alcohol consumption – can cause delayed hypoglycemia. - Exercise – increased glucose uptake may require dose reduction.
Frequently asked questions
What is the concentration of Humulin M3?+
Can Humulin M3 be used in children with diabetes?+
How should Humulin M3 be stored before use?+
What are the signs of hypoglycemia when using Humulin M3?+
Is it safe to inject Humulin M3 into the same site each day?+
Can alcohol affect the action of Humulin M3?+
What should I do if I miss a dose of Humulin M3?+
Does Humulin M3 interact with beta‑blockers?+
Are there any special considerations for pregnant women using Humulin M3?+
How does Humulin M3 differ from rapid‑acting insulin analogues?+
Can I mix Humulin M3 with other insulin types in the same syringe?+
What monitoring is required while on Humulin M3 therapy?+
Product details
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