SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glucose 50% w/v Concentrate for solution for infusion.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Anhydrous Glucose 50 %w/v equivalent to 500 g per 1000 ml or

Glucose Monohydrate    550 g per1000 ml

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Concentrate for solution for infusion.

Clear, slightly yellow solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Glucose 50% w/v is for use in admixtures to provide temporary relief from the symptoms of increased intracranial pressure and hypoglycaemic coma and is also indicated for the supplementation of energy in parenteral nutrition.

4.2 Posology and method of administration

Posology

The posology is dependent upon the age, weight and clinical condition of the patient. Administration

The solution is for administration by intravenous infusion following appropriate dilution or incorporation in to a parenteral nutrition admixture.

The resultant admixture should be administered through a central or peripheral venous line depending on its final osmolarity. If the final mixture, to be administered, is hypertonic it may cause irritation of the vein when administered into a peripheral vein.

When Glucose 50% w/v is used in conjunction with amino acids, the rate of administration of glucose should not exceed 1g/kg/hour for optimal protein anabolism.

Use in Paediatric Patients

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in paediatric intravenous fluid therapy (see section 4.4).

4.3 Contraindications

There are no known contraindications to this solution.

4.4 Special warnings and precautions for use

Not for direct intravenous infusion. Must be appropriately diluted before use. The admixture obtained should be administered through a central or peripheral venous line depending on its final osmolarity.

Unless appropriately diluted infusion of hypertonic glucose solutions into a peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly hypertonic solutions should only be administered through an indwelling intravenous catheter with the tip located in a large vein such as the superior vena cava.

Prolonged intravenous infusion of this solution may cause thrombophlebitis extending from the site of infusion.

Glucose tolerance may be impaired in patients with renal failure.

Administration to diabetics for appropriate clinical reasons should be monitored closely.

Paediatric population

Newborns - especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects. Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitits, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

In order to avoid potentially fatal over infusion of intravenous fluids to the neonate, special attention needs to be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medicines to neonates, a bag of fluid should not be left connected to the syringe.

When using an infusion pump all clamps on the intravenous administration set must be closed before removing the administration set from the pump, or switching the pump off. This is required regardless of whether the administration set has an antifree flow device.

The intravenous infusion device and administration equipment must be frequently monitored.

4.5 Interaction with other medicinal products and other forms of interaction

This solution should not be administered with, before or after an administration of blood through the same infusion equipment because of the possibility of pseudoagglutination.

4.6    Pregnancy and lactation

This product has been used in pregnant women and no harmful effects are known with respect to the cause of pregnancy and the health of the unborn and the neonate.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8.    Undesirable effects

Anaphylactic reaction, hypersensitivity, pyrexia and chills have also been reported.

The solution is hypertonic and liable to cause venous thrombosis at the site of injection.

In the event of an adverse reaction, discontinue infusion.

4.9    Overdose

In the event of an adverse reaction, discontinue infusion.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not applicable.

5.2    Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hydrochloric Acid Water for Injections

6.2    Incompatibilities

This solution should not be used in conjunction with additives incompatible with glucose.

6.3    Shelf life

Unopened: 18 months

It is recommended that the product is used immediately after removal from the overpouch. From a microbiological point of view, any admixture should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C. Preparation of the admixture should take place under controlled and validated aseptic conditions.

6.4    Special precautions for storage

Do not store above 25 °C.

For further information, see section 6.3.

6.5 Nature and contents of container

The product is a clear, colourless solution in a plastic Viaflex® container. The plastic is a PVC designated PL-146.

The containers are sealed in a plastic overpouch.

The solutions are supplied in 500ml, 1000ml, 1500ml, 2000ml and 3000ml fill volumes.

6.6 Special precautions for disposal and other handling

Dilution or addition to parenteral nutrition admixtures must take place in controlled and validated aseptic conditions.

The product should be inspected visually for particulate matter and discoloration after admixing and prior to administration. Do not administer unless the solution is clear and the seal is intact.

Check compatibility with other admixture components before use.

Additives known or determined to be incompatible with glucose as a diluent should not be used. The instructions for use of the medication to be added, including information on storage, must be consulted.

Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of the glucose solution is appropriate.

Mix the solution thoroughly when additives have been introduced.

Use of an in-line filter is recommended during administration of all parenteral solutions where possible.

Single use only.

Do not store partially used bags.

Discard any unused portion, waste materials and all associated devices.

Risk of Air Embolism

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

7 MARKETING AUTHORISATION HOLDER

Baxter Healthcare Ltd.

Caxton Way Thetford Norfolk IP24 3SE

MARKETING AUTHORISATION NUMBER

PL.0116/0271

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/12/1997    / 27/02/2004

DATE OF REVISION OF THE TEXT

30/09/2014