Glucose 10% Intravenous Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 10% Intravenous Infusion
2. Qualitative and Quantitative Composition
Dextrose (glucose) monohydrate C6H1206 H20 Ph. Eur. equivalent to 100.00g anhydrous dextrose per litre. Water for Injections Ph Eur qs. 1000ml 555mmol/l. Approximately 1720 kJ/litre (400 kcal/litre)
3. Pharmaceutical Form
Sterile non-pyrogenic infusion solution in flexible PVC bags with an infusion site, and an injection site for addition of medicinal products.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
10% glucose solution is indicated for supplemental intravenous nutrition as a preferred
source of carbohydrate
4.2. Posology and Method of Administration
For intravenous infusion under medical supervision, via a central venous catheter. If a peripheral vein has to be used in emergency situations, the solution should be given slowly and the site should be alternated regularly.
Single use only.
The volume of 10% glucose solution needed as supplemental nutrition will vary with patient age, body weight, complementary treatment and severity of the clinical condition. These factors should be taken into account during infusion therapy. There is no recommended dose as this is a matter for clinical judgment and laboratory assessment in each case.
Contra-indications
4.3.
Conditions of water excess. The use of hyperosmotic glucose solutions is contraindicated in patients with anuria, intracranial or intraspinal haemorrhage, and in delirium tremens where there is dehydration. Hyperglycaemia resulting from infusion with glucose solutions following acute ischaemic stroke is implicated in increasing cerebral ischaemic brain damage and impaired recovery.
4.4. Special Warnings and Precautions for Use
- Do not use after date of expiry printed on the bag
- Do not use unless the solution is clear and the container undamaged
- Confirm additive compatibility before use
- Discard any unused solution
- Infusion rate should be sufficiently slow to allow detection of osmotic diuresis
- Glucose infusions are incompatible with blood for transfusion as haemolysis and clumping may occur; do not administer through the same infusion equipment as blood or blood components for transfusion (either before, during or after their administration).
- If more than 180g glucose is given per day (equivalent to 1.8 litres) frequent monitoring of blood glucose is required and insulin may be necessary.
- Prior to and during infusion serum and/or urinary electrolytes and glucose should be monitored to assess the nature and severity of fluid depletion and electrolyte imbalance. Close monitoring of patients with diabetes mellitus, and in patients with renal failure, is necessary during glucose infusion.
- Use with caution in severe malnutrition (when glucose infusion can cause sodium retention, oedema and heart failure), and in thiamine deficiency. In patients with hepatic failure, excessive glucose infusion may be detrimental in portasystemic encephalopathy.
4.5. Interactions with other Medicaments and other forms of Interaction
Confirm additive compatibility before use. See section 6.2 Incompatibilities.
4.6 Fertility, pregnancy and lactation
It is particularly important to avoid maternal hyperglycaemia during intravenous glucose infusion in the perinatal period in view of the possibility of inducing neonatal hypoglycaemia. 4.7. Effects on Ability to Drive and Use Machines
4.8 Undesirable effects
Hypertonic glucose solutions may have a low pH and may cause venous irritation, local pain and thrombophlebitis. Intravenous infusion of glucose solutions can lead to the development of fluid and electrolyte disturbances including hypokalaemia, hypomagnesaemia and hypophospha-taemia. Hypokalaemia may complicate glucose infusions, especially when combined with insulin in the treatment of diabetic ketoacidosis. Hypophosphataemia may occur if glucose is used as a feed without added phosphate. In the event of adverse reaction stop infusion immediately.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard 4.9. Overdose
Severe over-infusion may cause plasma hyperosmolality and osmotic diuresis. Prolonged or rapid administration of hyperosmotic solutions may result in hyperglycaemia and dehydration. Treatment is symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: electrolyte with carbohydrate, ATC code: B05BB02 Glucose is rapidly absorbed into cells and metabolized into carbon dioxide and water with the release of energy. 10% glucose solution allows cellular rehydration and glucose serves as a preferred source of carbohydrate for cellular nutrition.
5.2. Pharmacokinetic Properties
The maximum rate of glucose utilization has been estimated to be about 500800 mg/kg body weight /hour.
5.3. Preclinical Safety Data
6.1 List of excipients
Water for Injections Ph. Eur.
6.2. Incompatibilities
The compatibility of additives must be confirmed before use.
6.3. Shelf Life
As packaged for sale 2 years.
After opening overwrap: Use immediately on removal from overwrap.
6.4. Special Precautions for Storage
Do not store above 25°C. Do not freeze. Store in the original outer container.
6.5 Nature and contents of container
■ MACOFLEX: flexible PVC bags
■ MACOFLEX N: polyolefin bags
Bags are provided with a PVC or polypropylene infusion site, and polycarbonate-polyisoprene injection site for addition of medicinal products.
Bags contain 50 ml, 100 ml, 250 ml, 500 ml or 1000 ml solution and are individually overwrapped in transparent polypropylene laminate.
Not all pack sizes may be marketed.
6.6. Instruction for Use/Handling
Remove the bag from the plastic overwrapping. Do not use unless the solution is clear and the container undamaged. Remove the protector and connect by clamping to the administration set.
7 MARKETING AUTHORISATION HOLDER
Macopharma (UK) Ltd, 8th floor -Regal House 70 London Road Twickenham-Middlesex TW1 3QS
8. Marketing Authorisation Number
PL 12580/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2009
10 DATE OF REVISION OF THE TEXT
19/10/2015