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 being treated with DBL Sodium Acetate Concentrated Injection?
DBL Sodium Acetate Concentrated Injection contains the active ingredient sodium acetate.
DBL Sodium Acetate Concentrated Injection can be added to total parenteral nutrition
(TPN) solutions as a source of sodium and acetate ions, or to increase the pH of the
solution. It can also be used to treat low blood sodium (hyponatraemia). For more
information, see Section
1. Why am I being treated with DBL Sodium Acetate Concentrated Injection? in the full CMI.
2. What should I know before treatment with DBL Sodium Acetate Concentrated Injection?
Do not use if you have ever had an allergic reaction to sodium acetate or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Sodium Acetate Concentrated Injection and affect
how it works.
4. How is DBL Sodium Acetate Concentrated Injection given?
DBL Sodium Acetate Concentrated Injection should only be used under the supervision
of your doctor.
It is usually given as an intravenous injection or an infusion (i.e. a slow injection
through a 'drip' into the vein).
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight.
5. What should I know during treatment with DBL Sodium Acetate Concentrated Injection?
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Things you should do
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Tell your doctor, nurse or pharmacist if you have any concerns before, during or after
administration of DBL Sodium Acetate Concentrated Injection.
Remind any doctor, dentist and pharmacist who are treating you that you are being
given DBL Sodium Acetate Concentrated Injection.
If you plan to have surgery that needs a general anaesthetic, tell your doctor that
you are being given DBL Sodium Acetate Concentrated Injection.
If you are about to have any blood tests, tell your doctor that you are being given
this medicine. It may interfere with the results of some tests.
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Looking after your medicine
|
DBL Sodium Acetate Concentrated Injection will be stored in the pharmacy or on the
ward.
Keep in a cool, dry place, protected from light, where the temperature stays below
30°C.
Do not use this medicine after the expiry date.
|
6. Are there any side effects?
Side effects include: thirst, dry mouth or eyes, fever, fast or irregular heart rate,
headache, dizziness, restlessness, weakness, mood changes, muscle or twitching, or
pain at the infusion site. Serious side effects include: sleepiness or confusion,
convulsions or difficulty breathing.
Active ingredient:
sodium acetate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about DBL Sodium Acetate Concentrated
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 being treated with DBL Sodium Acetate
Concentrated Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Sodium Acetate Concentrated Injection?
DBL Sodium Acetate Concentrated Injection contains the active ingredient sodium acetate. DBL Sodium Acetate Concentrated Injection can be added to total parenteral nutrition
(TPN) solutions as a source of sodium and acetate ions, or to increase the pH of the
solution. It can also be used to treat low blood sodium (hyponatraemia).
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why DBL Sodium Acetate Concentrated
Injection has been prescribed for you.
2. What should I know before treatment with DBL Sodium Acetate Concentrated Injection?
Warnings
Do not use DBL Sodium Acetate Concentrated Injection if you:
have an allergy to sodium acetate. 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
rash, itching or hives on the skin.
have any of the following conditions:
high blood sodium
fluid retention
severe kidney disease
severe burns
severe or prolonged diarrhoea or vomiting
uncontrolled diabetes mellitus
high blood pH
low blood calcium
low blood chloride
low blood potassium.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
heart failure
fluid retention or oedema
kidney disease
liver disease
high blood pressure
low or no urine production.
take any medicines for any other condition.
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.
Your doctor will discuss the possible risks and benefits of being given DBL Sodium
Acetate Concentrated Injection during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks and benefits of being given DBL Sodium
Acetate Concentrated Injection during breastfeeding.
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.
Some medicines may interfere with DBL Sodium Acetate Concentrated Injection and affect
how it works. These include:
corticosteroids or corticotrophin
pain killers such as aspirin
barbiturates, medicines used to treat epilepsy
antibiotics, medicines used to treat infections, particularly doxycycline
quinidine, a medicine used to control heart rhythm
ephedrine or pseudoephedrine
lithium, a medicine used to treat some psychiatric disorders
diuretics (fluid tablets), such as bumetanide, frusemide or thiazide diuretics
potassium supplements.
These medicines may be affected by DBL Sodium Acetate Concentrated Injection or may
affect how well it works. You may need different amounts of your medicine or you may
need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while being given DBL Sodium Acetate Concentrated Injection.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Sodium Acetate Concentrated
Injection.
4. How is DBL Sodium Acetate Concentrated Injection given?
How is it given?
DBL Sodium Acetate Concentrated Injection should only be used under the supervision
of your doctor.
It is usually given as an intravenous injection or an infusion (i.e. a slow injection
through a 'drip' into the vein).
How much is given?
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight.
If too much is given (overdose)
As this medicine is given to you under the supervision of your doctor, it is very
unlikely that you will receive too much.
If you think that you have been given too much DBL Sodium Acetate Concentrated Injection,
you may need urgent medical attention.
Symptoms of a sodium acetate overdose include the side effects listed under Section
6. Are there any side effects? but are usually of a more severe nature.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with DBL Sodium Acetate Concentrated Injection?
Things you should do
Tell your doctor, nurse or pharmacist if you have any concerns before, during or after
administration of DBL Sodium Acetate Concentrated Injection.
Remind any doctor, dentist and pharmacist who are treating you that you are being
given DBL Sodium Acetate Concentrated Injection.
If you plan to have surgery that needs a general anaesthetic, tell your doctor that
you are being given DBL Sodium Acetate Concentrated Injection.
If you are about to have any blood tests, tell your doctor that you are being given
this medicine. It may interfere with the results of some tests.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Sodium
Acetate Concentrated Injection affects you.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Looking after your medicine
DBL Sodium Acetate Concentrated Injection will be stored in the pharmacy or on the
ward.
Keep in a cool, dry place, protected from light, where the temperature stays below
30°C.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
DBL Sodium Acetate Concentrated Injection will be disposed of by a nurse or pharmacist.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Common side effects
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Common side effects
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What to do
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thirst
dry mouth or eyes
fever
fast or irregular heart rate
headache
dizziness
restlessness
weakness
mood changes
muscle weakness or twitching
pain at the infusion site
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Speak to your doctor if you notice any of these side effects and they worry you.
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Serious side effects
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Serious side effects
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What to do
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sleepiness or confusion
convulsions
difficulty breathing
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention. Serious side effects are rare.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any
of them. 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
What DBL Sodium Acetate Concentrated Injection contains
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Active ingredient
(main ingredient)
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sodium acetate
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Other ingredients
(inactive ingredients)
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water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Sodium Acetate Concentrated Injection does not contain lactose, sucrose, gluten,
tartrazine or any other azo dyes.
What DBL Sodium Acetate Concentrated Injection looks like
DBL Sodium Acetate Concentrated Injection is a clear, colourless solution.
It is available in the following strength and pack size:
50 x 1.64 grams in 10 mL ampoule (20 mmol/10 mL
AUST R 16262
Who distributes DBL Sodium Acetate Concentrated Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in September 2023.