SUMMARY CMI

GLUCOSE 5% and 10% FREEFLEX INJECTION

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using GLUCOSE 5% AND 10% FREEFLEX INJECTION?

Glucose 5% and 10% Injection contains the active ingredient Glucose.

Glucose Injection is used to is used to treat dehydration and low blood sugar levels.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

For more information, see Section 1. Why am I using Glucose 5% and 10% Freeflex? in the full CMI.

2. What should I know before I use GLUCOSE 5% AND 10% FREEFLEX INJECTION?

Glucose Injection will only be used if the solution is clear or slightly yellow, free of particles.

It should not be administered after the expiry date printed on the pack, if the pack is torn or shows signs of tampering.

You should not be given Glucose Injection if you are pregnant or breastfeeding unless your doctor says so.

For more information, see Section 2. What should I know before I use Glucose 5% and 10% Freeflex? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use GLUCOSE 5% AND 10% FREEFLEX INJECTION?

Glucose will be given to you by your doctor or a nurse by infusion or drip in the vein. Your doctor will have experience in injecting Glucose Injection and will choose the best dose for you

More instructions can be found in Section 4. How do I use Glucose 5% and 10% Freeflex? in the full CMI.

5. What should I know while using GLUCOSE 5% AND 10% FREEFLEX INJECTION?

For more information, see Section 5. What should I know while using Glucose 5% and Glucose 10% Freeflex? in the full CMI.

6. Are there any side effects?

All medicines have can have side effects. Sometimes they are serious, most of the time they are not.

Some patients experience local pain at the site of injection or a warm flush. Always tell your doctor if you have any unpleasant side effects.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

GLUCOSE 5% and 10% FREEFLEX INJECTION

Active ingredient(s): Glucose monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Glucose 5% and Glucose 10% Injection. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Glucose 5% and Glucose 10% Injection.

Where to find information in this leaflet:

1. Why am I using Glucose 5% and Glucose 10% Injection?
2. What should I know before I use Glucose 5% and Glucose 10% Injection?
3. What if I am taking other medicines?
4. How do I use Glucose 5% and Glucose 10% Injection?
5. What should I know while using Glucose 5% and Glucose 10% Injection?
6. Are there any side effects?
7. Product details

1. Why am I using GLUCOSE INJECTION?

Glucose Injection contains the active ingredient Glucose monohydrate.

Glucose is a sugar which provides energy for the body. Glucose Injection is used to treat dehydration and low blood sugar levels.

Your doctor will have explained why you are being treated with Glucose Injection and told you what dose you will be given.

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use GLUCOSE INJECTION?

Warnings

You should not be given Glucose Injection if:

• If the solution is not clear.
• Through the same tubing as those containing blood.
• After the expiry date printed on the pack.
• If the packaging is torn or shows sign of tampering.

It may have no effect at all, or worse, an entirely unexpected effect if you are given it after the expiry date has passed.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

You should not be given Glucose Injection if you have an allergy to:

• Any ingredient listed at the end of this leaflet
• Corn (maize) or corn substances
• Any similar medicines to Glucose Injection

Some symptoms of an allergic reaction may include:

• Shortness of breath
• Wheezing or difficulty breathing
• Swelling of the face, lips, tongue or other parts of the body
• Skin rash, itching or hives

You should not be given Glucose Injection if you have, or have had, any of the following medical conditions:

• Diabetic coma where blood sugar levels are excessively high
• Difficulty digesting sugar
• No production or passing of urine
• Bleeding within the head or spine
• Vitamin B1 deficiency
• Low blood potassium, magnesium or phosphorus
• Infections
• Stroke

It may not be safe for you to be given Glucose Injection you have any of these conditions

Glucose Injection should be given with caution to infants of diabetic mothers.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop that includes:

• Corticosteroids
• Alcohol
• Corticotrophin

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Glucose Injection.

4. How do I use GLUCOSE INJECTION?

How much Glucose injection is given

Glucose Injection will be given to you by your doctor or specially trained nurse by infusion or drip into the vein.

This allows the Glucose Injection to reach the body quickly, where it will treat dehydration and low blood sugar levels.

The dosage you will be given will depend on your age, weight, medical condition and response. Your doctor will have experience in injecting Glucose Injection and will choose the best dose for you.

If you use too much Glucose Injection

This rarely happens as Glucose Injection is usually administered under the care of a trained professional in a hospital or clinic setting.

However, if you are given Glucose Injection too quickly or too much, you may become confused or dehydrate. Tell your health care professional immediately.

5. What should I know while using Glucose Injection?

Looking after your medicine

Glucose Injection will be stored by your doctor or pharmacist under the recommended conditions.

It should be stored in a cool dry place where the temperature stays below 25°C.

When to discard your medicine (as relevant)

Any Glucose Injection which is not used and which is left in the container, will be disposed of in a safe manner by your doctor or pharmacist.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Glucose Injection.

All medicines can have some side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

The following is a list of possible side effects. Tell your doctor or pharmacist if you notice any of the following:

• Shortness of breath
• Flushing
• Swelling
• Fever
• Infection at the site of injection
• Inflammation at the site of injection
• Passing large amounts of urine, excessive thirst and having a dry mouth and skin

Do not be alarmed by this list. You may not experience any of them.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Glucose Injection contains

Do not take this medicine if you are allergic to any of these ingredients.

What Glucose Injection looks like

Glucose Injection looks like a clear colourless or slightly yellow solution in a Freeflex bag. It comes in various pack sizes. They can be identified by the AUST R numbers;

Freeflex Bags
Glucose 5%
50mL AUST R 144669
100mL AUST R 144671
250mL AUST R 144672
500mL AUST R 29599
1000mL AUST R 47389

Glucose 10%
500mL AUST R 29790

Who distributes Glucose Injection

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Ph: (02) 9391 5555

Fresenius Kabi New Zealand Limited
c/o GNZCC, HSBC Tower, Level 14, 188 Quay Street,
Auckland
New Zealand
Freecall: 0800 144 892

This leaflet was prepared in November 2021

Published by MIMS February 2022

1 Name of Medicine

Glucose.

2 Qualitative and Quantitative Composition

Glucose 10% is a sterile hypertonic solution of glucose 10% w/v in water for injections, containing no preservatives. pH 3.5 to 6.5.
Glucose 5% Freeflex is a sterile isotonic solution of glucose 5% w/v in water for injections, containing no preservatives. pH 3.5 to 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear colourless to slightly yellow solution.

4 Clinical Particulars

4.1 Therapeutic Indications

The solutions are indicated for intravenous fluid therapy designed to correct deficiencies in energy levels. Glucose 5% is also used to correct hydration levels. The solutions may also be used as solvents for intravenously administered drugs where compatibility has been established.

4.2 Dose and Method of Administration

Glucose 5% Injection may be administered intravenously via a peripheral vein. The maximum rate at which glucose can be administered without producing glycosuria is 0.5 g/kg/h.
Glucose 10% Injection is hypertonic and should preferably be administered via an IV catheter in a large central vein. If a peripheral vein is used a large arm vein should be selected and the infusion site changed daily. The rate of infusion should not exceed 0.5 g/kg/h to avoid glycosuria.
The dose of glucose is dependent on the age, weight and fluid, electrolyte, glucose and acid-base balance of the patient.
Solutions containing glucose should not be administered through the same lines as those containing whole blood due to the risk of haemolysis and clumping. It does not contain antimicrobials. For use in one patient, on one occasion only. Residue should be discarded.
Care should be taken with intravenous administration and injection technique to avoid injection site reactions and infections.

4.3 Contraindications

Glucose is contraindicated in the following:
diabetic coma where blood sugar levels are excessively high;
glucose-galactose malabsorption syndrome;
anuria;
intraspinal or intracranial haemorrhage;
in dehydrated delirium tremens patients;
known allergy to corn (maize) and corn products;
patients at risk for ischaemic stroke;
use after an ischaemic stroke episode.

4.4 Special Warnings and Precautions for Use

Glucose solutions should be used with caution in patients with overt or known subclinical diabetes mellitus, or with carbohydrate intolerance.
Intravenous administration of glucose solutions, especially as infusions, may cause fluid overload and a resultant dilution of serum electrolytes and possible peripheral and pulmonary oedema. Prolonged therapy should be monitored for changes in fluid balance, electrolyte concentration and acid-base balance.
Hyperglycaemia and glucosuria may occur as a result of an over rapid rate of infusion or metabolic insufficiency. Blood and urine glucose should be monitored regularly.
Glucose solutions should not be infused concomitantly through the same intravenous set as blood as agglomeration or haemolysis may occur.
Prolonged parenteral administration of glucose may affect insulin production. To avoid this it may be necessary to add insulin to the infusion. A review of the patient's oral hypoglycaemic agent or insulin requirements may be necessary.
Avoid use after an ischaemic stroke episode as under this condition the induced lactic acidosis aggravates the damage of brain tissues.
Thiamine diphosphate cocarboxylase is an essential coenzyme in carbohydrate metabolism, therefore patients having thiamine deficiency should be treated cautiously with glucose injection. This is particularly important in patients who chronically abuse alcohol as this may precipitate an overt deficiency syndrome, e.g. Wernicke's encephalopathy.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Glucose intravenous infusion preparations (an aqueous, i.e. electrolyte-free glucose solution) should not be administered simultaneously with blood preparations through the same administration set, because of the possibility of pseudo-agglutination or haemolysis.
Caution is advised when administering glucose intravenous infusion to patients treated with drugs leading to an increased vasopressin effect. The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hyponatraemia following treatment with IV fluids.
Drugs stimulating vasopressin release such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors (SSRIs), 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, opioids.
Drugs potentiating vasopressin action such as chlorpropamide, non-steroidal anti-inflammatory drugs (NSAIDs), cyclophosphamide.
Vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin.
Parenteral fluids, especially those containing sodium ions, should be administered with caution to patients receiving corticosteroids or corticotrophin.
Caution is advised when administering glucose intravenous infusion to patients treated with drugs that may increase the risk of hyponatraemia, such as diuretics and antiepileptics (e.g. oxcarbazepine).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Glucose 5% Injection is iso-osmotic with blood and may be administered intravenously via a peripheral vein. Local reactions such as phlebitis or venous thrombosis and extravasation may occur. A fever response and infection at the site of injection may also occur due to contamination of the solution or poor techniques of administration.
Hyperglycaemia and glycosuria may occur if glucose is administered at a rate greater than 0.5 g/kg/h. Disruption of the fluid and acid-base balance and dilution of electrolyte concentrations may occur during prolonged usage, resulting in oedema, hypokalaemia, hypomagnesaemia and hypophosphataemia (see Section 4.4 Special Warnings and Precautions for Use).
Vitamin B complex deficiency may occur with glucose administration.

Post-marketing adverse reactions.

Immune system disorders.

Metabolism and nutrition disorders.

Vascular disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Other adverse reactions (class reactions).

Reporting suspected adverse effects.

4.9 Overdose

Hyperglycaemia and glycosuria, if undetected, can lead to mental confusion, dehydration, hyperosmolar coma and death.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injection, hydrochloric acid and sodium hydrochloride for pH adjustment.

6.2 Incompatibilities

Additives may be incompatible with glucose. Do not administer such preparations unless the solution is clear. Do not store solutions containing additives unless compatibility has been proven. While some incompatibilities are readily observed, one must be aware that subtle physical, chemical and pharmacological incompatibilities can occur. The medical literature, the package insert and other available sources of information should be reviewed for a thorough understanding of possible incompatibility problems. In particular, the product information document of any added medication should be checked for any incompatibility with the glucose injection.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Glucose 5% injection in polyolefin freeflex bags.

Glucose 10% injection in freeflex bags.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Australia: Unscheduled.

Summary Table of Changes