Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or nurse.
1. Why am I being treated with DBL Acetylcysteine Injection Concentrate?
DBL Acetylcysteine Injection Concentrate contains the active ingredient acetylcysteine.
DBL Acetylcysteine Injection Concentrate is used to treat paracetamol (acetaminophen)
poisoning.
2. What should I know before I am given DBL Acetylcysteine Injection Concentrate?
You should not be given DBL Acetylcysteine Injection Concentrate if you have ever
had an allergic reaction to acetylcysteine or any of the ingredients lists at the
end of this leaflet.
3. What if I am taking other medicines?
4. How is DBL Acetylcysteine Injection Concentrate given?
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight. This medicine is given as an infusion (eg.
as a ‘drip’) into a vein. It must only be given by a doctor or nurse.
5. What should I know while I am being treated with DBL Acetylcysteine Injection Concentrate?
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Things you should do
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Remind any doctor, pharmacist or dentist you visit in the next few days that you have
been given this medicine recently.
Ensure you have any tests recommended by your doctor.
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Driving or using machines
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Avoid driving or using any machines or tools until you know how this medicine affects
you, as it may cause dizziness, light-headedness, blurred vision or seizures.
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Drinking alcohol
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Tell your doctor if you have a history of long-term alcohol use.
Be careful when drinking alcohol for the next few days after you have been given this
medicine, as it may cause light-headedness or dizziness in some people.
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6. Are there any side effects?
Side effects include: nausea or vomiting, generally feeling unwell, excessive shivering,
fever or sweating, pain or swelling in your joints, pain and inflammation at the injection
site, blurred vision or any eye pain, flushing or pain in your face, anxiety.
Serious side effects include: allergic reactions including rash, itching, swelling
of the face or difficulty breathing; chest pain, fast or irregular heart-beat; dizziness
or light-headedness; headache; seizure, jaundice (yellowing of skin and/or eyes);
bleeding or bruising more easily than normal; blueish colour to the skin, lips or
nails.
Active ingredient(s):
Acetylcysteine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being treated with DBL Acetylcysteine
Injection Concentrate.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about treatment with DBL Acetylcysteine Injection
Concentrate.
Where to find information in this leaflet:
1. Why am I being treated with DBL Acetylcysteine Injection Concentrate?
DBL Acetylcysteine Injection Concentrate contains the active ingredient acetylcysteine.
DBL Acetylcysteine Injection Concentrate is used to treat paracetamol (acetaminophen)
poisoning.
It works by reacting with a toxic metabolite of paracetamol to prevent it damaging
the liver.
This medicine is most effective when started within 8 hours of exposure to paracetamol.
2. What should I know before I am given DBL Acetylcysteine Injection Concentrate?
Warnings
You must not be given DBL Acetylcysteine Injection Concentrate if:
1. you are allergic to acetylcysteine or any of the ingredients listed at the end of
this leaflet.
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.
Always check the ingredients to make sure you can use this medicine.
If you are not sure whether you should be given DBL Acetylcysteine Injection Concentrate,
talk to your doctor or nurse.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
asthma or difficulty breathing
stomach ulcers
kidney problems
liver problems.
have a history of chronic or long-term alcohol use
take any medicines for any other condition, especially the following:
isoniazid and/or rifampicin (antibiotics often used together for the treatment of
tuberculosis (TB))
anticonvulsants including carbamazepine, phenytoin, phenobarbitone, primidone, sodium
valproate.
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
Tell your doctor if you are pregnant or are breast-feeding
If there is a need to consider using this medicine while you are pregnant or breastfeeding,
your doctor will discuss with you the benefits and risks of you being given it.
3. What if I am taking other medicines?
Tell your doctor or nurse 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.
Check with your doctor or nurse if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Acetylcysteine Injection Concentrate.
4. How is DBL Acetylcysteine Injection Concentrate given?
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.
How it is given
DBL Acetylcysteine Injection Concentrate is given as a slow infusion (eg. as a ‘drip’)
into a vein. It must only be given by a doctor or nurse.
How many infusions will you need
You will receive two separate infusions, containing different doses, as determined
by your doctor. You may also be given treatment for nausea at the same time.
If you experience side effects to DBL Acetylcysteine Injection Concentrate, you may
also be given an anti-histamine.
The overall duration of treatment is approximately 20 hours.
Your doctor may do some tests before and during treatment, to make sure the medicine
is working and to prevent unwanted side effects.
If you are given too much DBL Acetylcysteine Injection Concentrate
As DBL Acetylcysteine Injection Concentrate is given to you under the supervision
of a doctor, it is very unlikely that you will receive too much.
It is important to immediately tell your doctor or nurse if you experience a rash,
itching or hives on the skin, swelling of the face, lips, tongue or other parts of
the body, shortness of breath, wheezing or trouble breathing.
However, if you think that you have been given too much DBL Acetylcysteine Injection
Concentrate and/or if you experience severe side effects, you may need additional
urgent medical attention.
You should immediately:
talk to your doctor or nurse.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while I am being treated with DBL Acetylcysteine Injection Concentrate?
Things you should do
Remind any doctor, pharmacist or dentist you visit over the next few days that you
have been given DBL Acetylcysteine Injection Concentrate recently.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you have been given this medicine recently.
Keep all of your doctor's appointments so that your progress can be checked.
Driving or using machines
Be careful before driving or using any machines or tools until you know how DBL Acetylcysteine
Injection Concentrate affects you.
As with some other medicines, acetylcysteine may cause dizziness or light-headedness
in some people. It may also cause blurred vision or seizures.
Make sure you know how you react to this medicine before you drive a car, operate
machinery, or do anything else that could be dangerous.
Drinking alcohol
Be careful when drinking alcohol for a few days after being given this medicine.
This medicine may cause dizziness or light-headedness in some people.
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 nurse if you have
any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Symptoms of an allergic reaction, which 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 in the skin.
Other serious side effects, which may include:
headache
chest pain
fast or irregular heart beat
dizziness or light-headedness, feeling faint/fainting
seizure
jaundice (yellowing of skin and/or eyes)
bleeding or bruising more easily than normal
have a bluish colour to the skin, lips or nails
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Tell your doctor or nurse straight away if you notice any of these side effects.
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Tell your doctor or nurse 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.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Acetylcysteine Injection Concentrate contains
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Active ingredient
(main ingredient)
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Acetylcysteine
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Other ingredients
(inactive ingredients)
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Sodium hydroxide
Disodium edetate
Water for injections
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DBL Acetylcysteine Injection Concentrate does not contain lactose, sucrose, gluten,
tartrazine or any other azo dyes.
You should not be given this medicine if you are allergic to any of these ingredients.
What DBL Acetylcysteine Injection Concentrate looks like
DBL Acetylcysteine Injection Concentrate is a clear, colourless solution.
It is available as follows:
2 g in 10 mL glass ampoules (AUST R 121503)
Who distributes DBL Acetylcysteine Injection Concentrate
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in January 2025.
™ Trademark
© Pfizer Australia Pty Ltd 2025