GLUCOSE 20% Solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Glucose 20% w/v Solution for Infusion.
Qualitative and quantitative composition
Each ml contains 20% w/v of Glucose EP.
Pharmaceutical form
Solution for Infusion.
Therapeutic indications
Glucose 20% is hypertonic (in vitro tonicity, in a container) and provides a source of calories in a minimal volume of water. Glucose 20% is frequently used in both adults and children to restore blood ...
Posology and method of administration
Dosage of Glucose depends on the age, weight, clinical condition of the patient. Fluid and acid base balance, serum glucose, serum sodium, and other electrolytes may need to be monitored before and during ...
Contraindications
Glucose 20% is contraindicated in patients with: hypersensitivity to the active substance or to any excipients listed in section 6.1 and known allergy to corn or corn products the glucose – galactose malabsorption ...
Special warnings and precautions for use
Rapid administration of hypertonic glucose solutions may produce substantial hyperglycaemia and hyperosmolar syndrome; patients should be observed for signs of mental confusion and loss of consciousness, ...
Interaction with other medicinal products and other forms of interaction
The effects of insulin are reversed by glucose. Drugs increasing vasopressin effect, listed below, lead to reduced renal electrolyte free water excretion and increase the risk of hospital acquired hyponatraemia ...
Pregnancy and lactation
There is no, or inadequate evidence of safety of the drug in human pregnancy, but it has been in wide use for many years without apparent harmful consequence. Intravenous glucose may result in fetal insulin ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data) Metabolism and ...
Overdose
Overdose of Glucose 20% may lead to hyperglycaemia and glycosuria leading to dehydration, hyperosmolar coma and death. The blood levels of glucose can be reduced by slow infusion of insulin. Careful monitoring ...
Pharmacodynamic properties
Pharmacotherapeutic group: Solutions for parenteral nutrition, Carbohydrates ATC code: B05BA03 The metabolism of glucose is an energy source for the body.
Pharmacokinetic properties
Glucose is rapidly metabolised into carbon dioxide and water.
Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
List of excipients
Hydrochloric acid Water for injections Ph. Eur.
Incompatibilities
Glucose solutions which do not contain electrolytes, should not be administered concomitantly with blood through the same infusion set, because of the possibilities of agglomeration.
Shelf life
Shelf life: 48 months.
Special precautions for storage
Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.
Nature and contents of container
100ml type I clear colourless glass infusion bottle with rubber stopper and cap, packed in cardboard cartons to contain 1, 10 or 25 vials x 100ml. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Use as directed by the physician. Glucose 20% is provided in a concentration that is ready for administration. Any unused medicinal product or waste material should be disposed of in accordance with local ...
Marketing authorization holder
hameln pharma limited, Nexus Hurricane Lane, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Marketing authorization number(s)
PL 01502/0083
Date of first authorization / renewal of the authorization
06/06/2013
Date of revision of the text
01/04/2020
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