Glucose 40% W/V Concentrate For Solution For Infusion.
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 40% w/v Concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Glucose 40 %w/v equivalent to 400 g per 1000 ml or
Glucose Monohydrate 440 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 40% 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 40% 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 contra-indications 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
Glucose Intravenous Infusion 40% w/v should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment, because of the possibility of pseudo-agglutination.
The solution should not be used in conjunction with additives known to be incompatible with glucose.
4.6 Pregnancy and lactation
The safety of the use of Glucose Intravenous Infusion BP 40% w/v during pregnancy or lactation has not been established.
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
The method of administration of this product makes the possibility of overdose very unlikely. However in the event of an overdose, it is recommended that the infusion is discontinued.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glucose Intravenous Infusion BP 40% w/v provides an alternative or additional source of energy for patients who are unable to ingest sufficient glucose for their metabolic needs. The product also provides temporary relief from increased intracranial pressure by causing osmotic loss of fluid from cells. The solution also provides relief from hypoglycaemic coma by providing a source of glucose.
5.2 Pharmacokinetic properties
After infusion into the blood stream, Glucose Intravenous Infusion BP 40% w/v is rnetabolised, distributed and excreted in the same manner as glucose taken orally.
5.3 Preclinical safety data
No data is presented as glucose is a basic and widespread element in mammalian metabolism and therefore conventional animal safety testing is not appropriate.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric Acid Water for Injections
6.2 Incompatibilities
Glucose Intravenous Infusion 40% w/v should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment, because of the possibility of pseudo-agglutination.
The solution should not be used in conjunction with additives known to be 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 products are supplied in PL-146 plastic (0.010” - 0.017” thickness) Viaflex® containers which are sealed in a polypropylene, high density polyethylene or polyester/polypropylene laminated overpouch, or in dual bag containers sealed in a polypropylene, high density polyethylene or polyester/polypropylene laminated overpouch.
The container is sealed with a close made either from PL-146 or from a blue-coloured plasticised PVC designated PL-141.
The solutions are supplied in 500ml, 1,000ml and 1500ml 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 Limited.,
Caxton Way,
Thetford,
Norfolk,
IP24 3SE
8 MARKETING AUTHORISATION NUMBER
PL 0116/0270
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/12/1997 / 17/04/2001
10 DATE OF REVISION OF THE TEXT
30/09/2014