Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Glucose Intravenous Infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you being given Glucose Intravenous Infusion against the benefits they expect it to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases, this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Glucose Intravenous Infusion is used for

Glucose is a sugar which provides energy for the body. It is naturally present in body fluids and is needed for normal body function. Glucose Intravenous Infusion is given to patients who have low levels of sugar in their blood or are dehydrated.

Glucose Intravenous Infusion may also be used for the dilution of other medicines before injecting them into the body.

It may be used for the treatment of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Glucose Intravenous Infusion.

Before you are given Glucose Intravenous Infusion

When Glucose Intravenous Infusion must not be given

You should not be given this medicine if the packaging is torn or show signs of tampering or if the expiry date on the pack has passed.

You will not be given Glucose Intravenous Infusion if:

1. You have an allergy to

• glucose, or any of the ingredients listed at the end of this leaflet
• carbohydrates
• corn (maize) or corn products

2. You have or have had the following medical conditions

• diabetes
• difficulty digesting sugar
• severely dehydrated
• not passing urine
• bleeding in the brain or spinal cord
• ischaemic stroke
• head trauma within past 24 hours

It may not be safe for you to be given Glucose Intravenous Infusion, if you are not sure, check with your doctor.

Before you are given it

Tell your doctor if:

1. You have any allergies to:

• any other medicine
• any other substances, such as foods, preservatives or dyes

2. You have or have had any medical conditions, especially the following:

• ischaemic heart disease
• problem digesting carbohydrates or sugars
• alcoholism
• vitamin B deficiency
• low levels of potassium, magnesium or phosphorus in your blood

3. You are pregnant or intend to become pregnant

Your doctor will discuss the possible risks and benefit of being given Glucose Intravenous Infusion during pregnancy.

4. You are breast-feeding or plan to breast feed

It is not known whether glucose passes into breast milk. Discuss with your doctor the risks and benefits of taking Glucose Intravenous Infusion whilst breastfeeding.

Taking other medicines

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

Some medicines interfere with glucose and affect how it works. These include:

• chlorpropamide, non-steroidal anti-inflammatory drugs (NSAIDS), cyclophosphamide
• clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, ifosfamide, antipsycotics, opioids
• diuretics and antiepileptics (e.g. oxcarbazepine)
• corticosteroids or corticotropin

Your doctor will advise you about continuing to take other medicines.

How Glucose Intravenous Infusion is given

Treatment with Glucose Intravenous Infusion usually occurs in a hospital. It will be given to you as a slow injection into one of your veins (this is called an intravenous infusion) by your doctor or a specially trained nurse.

How much is given

Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys are working, and whether or not other medicines are being given at the same time.

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

Never administer this medicine yourself.

If you are given too much (overdose)

This rarely happens as Glucose Intravenous Infusion is administered under the care of a highly trained doctor or nurse.

However, if you are given too much glucose you may experience some of the effects listed under "Side Effects" below.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Glucose Intravenous Infusion. Like other medicines, glucose can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

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

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

Tell your doctor or nurse as soon as possible if you notice any of the following:

• pain, bruising or swelling at site of injection
• flushing
• any swelling of the face or limbs
• shortness of breath
• wheezing or difficulty breathing
• rash, itching or hives on the skin

These are the more common side effects of glucose. Mostly these are mild and short-lived.

Tell your doctor immediately if you notice any of the following:

• confusion
• dehydration, thirsty, dry mouth
• passing large amounts of urine
• fever/chills
• headache, nausea, seizures lethargy, vomiting

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.

Product description

What it looks like

Glucose Intravenous Infusion is a clear, colourless solution contained in glass vial.

Glucose Intravenous Infusion can be identified by an Australian Register Number, which is found on the packaging - AUST R 11371

Ingredients

Glucose Intravenous Infusion contains 54.99 mg glucose monohydrate (equivalent to 50 mg glucose) as the active ingredient.

It also contains:

• water for injections
• sodium hydroxide
• hydrochloric acid.

It does not contain a preservative.

Supplier

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

This leaflet was prepared in September 2021.

© Pfizer Australia Pty Ltd 2021.

Published by MIMS November 2021

1 Name of Medicine

Glucose monohydrate.

2 Qualitative and Quantitative Composition

Each mL of solution contains 54.99 mg glucose monohydrate (equivalent to 50 mg glucose). When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. pH is 3.5 to 6.5 and osmolality 250 to 350 mOsm/kg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, intravenous infusion.
Sterile isotonic preservative-free solutions containing glucose monohydrate.

4 Clinical Particulars

4.9 Overdose

Excessive administration of Glucose Intravenous Infusion BP 5% can cause hyperglycaemia, adverse effects on water and electrolyte balance, and corresponding complications (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). For example, severe hyperglycaemia and severe dilutional hyponatraemia, and their complications, can be fatal. Clinically significant overdose of glucose intravenous infusion may, therefore, constitute a medical emergency.
Symptoms. Prolonged administration or rapid infusion of large volumes of isotonic solutions may cause oedema or water intoxication. Hyperglycaemia and glycosuria may occur, and if undetected can lead to mental confusion, dehydration, hyperosmolar coma and death.
The signs and symptoms of over infusion will also be related to the nature of any additive drugs.
Treatment. The infusion should be discontinued and the patient observed for appropriate signs and symptoms related to glucose and/or additive drugs administered, and appropriate symptomatic and supportive measures instituted as required, such as administration of insulin. Fluid overload and biochemical imbalance should be treated with corrective therapy. If diuresis is adequate, administration of a slightly hypotonic electrolyte solution in a quantity calculated to replace the net quantity of fluid and specific electrolytes (particularly potassium) lost to osmodiuresis, whilst continuously monitoring serum electrolytes, fluid balance and acid-base status is recommended.
A suitable basic solution for replacing fluids and major electrolytes could be made up according to the following formulation per 1000 mL: Na⁺: approx. 120 mmol, K⁺: approx. 30 mmol, Cl^-: approx. 150 mmol. Other electrolytes should also be replaced to make up for losses incurred.
In addition to replacement of net losses of fluids and electrolytes to diuresis, any acid-base imbalance should be corrected whilst continuing to monitor laboratory values.
In patients with oliguria or those with anuria, peritoneal dialysis or extracorporeal haemodialysis using carbohydrate-free solutions can be considered as a last resort.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The active ingredient, glucose, in Glucose Intravenous Infusion BP 5% is not a mutagen. It is a basic nutrient in all living cells.
Carcinogenicity. The active ingredient, glucose, in Glucose Intravenous Infusion BP 5% is not carcinogenic. It is a basic nutrient in all living cells.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The molecular formula is C₆H₁₂O₆.H₂O and the chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGLUCMO.gif CAS number. 77938-63-7, 14431-43-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GLU5PFST.gif