Europe — EMA
Glucosio S.A.L.F.
Glucosio S.A.L.F. is a glucose monohydrate injection used for hypoglycemia, fluid replacement, and parenteral nutrition support in EU markets.
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What is Glucose Monohydrate?
Glucosio S.A.L.F. is a parenteral carbohydrate solution whose active ingredient is glucose monohydrate, supplied as a sterile solution for injection. The product is manufactured in the European Union and is classified as a carbohydrate solution/excipient used as an adjunct in parenteral nutrition. It is intended for intramuscular, intravenous, or subcutaneous administration to provide an immediate source of glucose and to assist in maintaining osmotic balance during fluid therapy.
What is Glucose Monohydrate used for?
Glucosio S.A.L.F. is employed in clinical settings where rapid glucose supplementation or fluid balance is required.
- Treatment of documented hypoglycemia when oral glucose is not feasible. - Component of parenteral nutrition regimens for patients unable to receive enteral feeding. - Support for fluid and electrolyte replacement in perioperative or trauma care. - Provision of an energy substrate during prolonged fasting or critical illness. - Adjunct in neonatal intensive care to maintain glucose homeostasis. - Use in surgical patients to prevent peri‑operative hypoglycemia.
What are the side effects of Glucose Monohydrate?
Adverse reactions to Glucosio S.A.L.F. are generally related to the glucose load and the route of administration.
Common: - Transient hyperglycemia, especially in patients with impaired insulin response. - Local irritation or pain at the injection site. - Mild nausea or vomiting following rapid infusion. - Electrolyte shifts such as mild hyponatremia due to osmotic effects. - Headache associated with rapid changes in blood glucose.
Serious: - Severe hyperglycemia leading to osmotic diuresis. - Allergic or anaphylactic reaction to excipients. - Volume overload causing pulmonary edema in susceptible individuals. - Severe hypoglycemia if glucose is administered after insulin without monitoring. - Life‑threatening electrolyte disturbances (e.g., severe hyponatremia).
What precautions apply to Glucose Monohydrate?
When using Glucosio S.A.L.F., clinicians should observe several precautions to minimize risk and ensure appropriate therapy.
- Verify blood glucose level before and after administration to avoid over‑correction. - Adjust dose in patients with renal or hepatic impairment due to altered glucose metabolism. - Monitor fluid balance closely in patients at risk for volume overload or heart failure. - Use caution in individuals with known hypersensitivity to any component of the solution. - Limit infusion rate according to manufacturer guidelines to reduce the chance of hyperglycemia. - Consider alternative carbohydrate sources for patients with uncontrolled diabetes mellitus. - Ensure aseptic technique to prevent contamination of the injection solution.
What does Glucose Monohydrate interact with?
Glucosio S.A.L.F. may interact with other medications or clinical conditions that affect glucose homeostasis or fluid balance.
Avoid: - Concomitant use of high‑dose insulin without glucose monitoring, which can precipitate severe hypoglycemia. - Co‑administration with other hypertonic glucose solutions, increasing risk of hyperglycemia and osmotic complications. - Use with diuretics in patients prone to electrolyte disturbances without close monitoring.
Use with caution: - Concurrent administration of corticosteroids, which can raise blood glucose levels. - Beta‑blockers that may mask symptoms of hypoglycemia. - Medications that affect renal function, such as ACE inhibitors, requiring careful fluid assessment. - Anticoagulants, as rapid infusion may affect coagulation parameters. - Drugs that alter electrolyte balance, like potassium‑sparing agents.
Frequently asked questions
What is the primary active ingredient in Glucosio S.A.L.F.?+
In which routes can Glucosio S.A.L.F. be administered?+
When is Glucosio S.A.L.F. indicated for use?+
Can Glucosio S.A.L.F. be used in pediatric patients?+
What monitoring is recommended during infusion of Glucosio S.A.L.F.?+
Is there a risk of allergic reaction to Glucosio S.A.L.F.?+
How does Glucosio S.A.L.F. differ from oral glucose tablets?+
What should be considered for patients with heart failure?+
Can Glucosio S.A.L.F. be combined with insulin therapy?+
Is Glucosio S.A.L.F. available over the counter?+
What storage conditions are recommended for Glucosio S.A.L.F.?+
How does Glucosio S.A.L.F. contribute to osmotic balance?+
Product details
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