Europe — EMA
Humulin S (Soluble) (Insulin Human (Rdna))
Humulin S (soluble) is a 100 IU/mL recombinant human insulin injection used for type 1 and type 2 diabetes management in the EU.
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What is Insulin Human (Rdna)?
Humulin S (Soluble) is a sterile solution for injection that contains insulin human (rDNA) at a strength of 100 IU/mL. It is a recombinant form of human insulin approved in the European Union for prescription use. The product is administered subcutaneously to replace or supplement endogenous insulin in patients with diabetes, providing a rapid‑acting glucose‑lowering effect. Humulin S is stored in a refrigerator and must be protected from light.
What is Insulin Human (Rdna) used for?
Humulin S is indicated for the management of diabetes mellitus when insulin therapy is required.
- Type 1 diabetes mellitus in adults, adolescents, and children. - Type 2 diabetes mellitus when oral agents no longer achieve glycemic targets. - Use as part of a basal‑bolus insulin regimen to control mealtime glucose excursions. - Hospital or perioperative settings where rapid insulin action is needed. - Adjunct therapy during pregnancy (category B) under medical supervision. - Transition from intravenous insulin infusion to subcutaneous therapy in critical care.
What are the side effects of Insulin Human (Rdna)?
Adverse reactions to Humulin S can vary in frequency and severity; they are categorized as common or serious.
Common: - Mild hypoglycemia, especially if meals are delayed or carbohydrate intake is insufficient. - Injection site reactions such as redness, swelling, or itching. - Lipodystrophy presenting as localized thickening or loss of subcutaneous fat. - Transient weight gain due to fluid retention. - Nausea or abdominal discomfort.
Serious: - Severe hypoglycemia with neuroglycopenic symptoms (confusion, seizures, loss of consciousness). - Allergic reactions ranging from urticaria to anaphylaxis. - Edema or heart failure exacerbation in susceptible patients.
What precautions apply to Insulin Human (Rdna)?
Before prescribing Humulin S, clinicians should evaluate several safety considerations to minimize risk.
- Assess renal and hepatic function, as impairment can prolong insulin action. - Review history of hypoglycemia unawareness or previous severe episodes. - Adjust dose during pregnancy, lactation, or in pediatric patients under close supervision. - Monitor for signs of cardiovascular disease, especially in patients with edema or heart failure. - Avoid use in patients with known hypersensitivity to recombinant human insulin or any excipients. - Store the product refrigerated and discard after the indicated in‑use period to maintain potency.
What does Insulin Human (Rdna) interact with?
Humulin S may interact with other medicines that affect glucose metabolism or insulin pharmacokinetics.
Avoid: - Concurrent use of other rapid‑acting insulins or insulin analogues without dose adjustment. - Co‑administration with sulfonylureas or meglitinides that increase risk of hypoglycemia.
Use with caution: - Beta‑blockers can mask hypoglycemia symptoms; monitor glucose closely. - Corticosteroids and thiazide diuretics may raise blood glucose, requiring dose titration. - Oral contraceptives and hormone replacement therapy can alter insulin requirements. - Alcohol consumption can potentiate insulin effect and cause delayed hypoglycemia.
Frequently asked questions
What is the concentration of insulin in Humulin S solution?+
Can Humulin S be used in children with type 1 diabetes?+
How should Humulin S be stored before use?+
What are the signs of mild hypoglycemia while using Humulin S?+
Is it safe to inject Humulin S into the same site repeatedly?+
Can Humulin S be used during pregnancy?+
What should I do if I experience an allergic reaction to Humulin S?+
Does alcohol affect the action of Humulin S?+
Are there any medications that increase the risk of low blood sugar with Humulin S?+
How does Humulin S differ from long‑acting insulin formulations?+
What monitoring is recommended after starting Humulin S?+
Can Humulin S be mixed with other injectable diabetes medicines?+
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