SUMMARY CMI
DOTAGRAF®
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.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
1. Why am I given DOTAGRAF?
DOTAGRAF contains the active ingredient gadoteric acid. DOTAGRAF is a contrast agent used during a magnetic resonance imaging (MRI) examination.
For more information, see Section 1. Why am I given DOTAGRAF? in the full CMI.
2. What should I know before I am given DOTAGRAF?
Do not use if you have ever had an allergic reaction to DOTAGRAF or any of the ingredients listed at the end of the CMI.
Talk to your doctor, radiographer or nurse if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given DOTAGRAF? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with DOTAGRAF and affect how it works.
Tell your doctor, radiographer or nurse if you are taking a beta-blocker or another medicine used to treat high blood pressure or a heart condition.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How am I given DOTAGRAF?
DOTAGRAF is injected into your vein by a doctor, radiographer or nurse immediately before or during your MRI examination.
More instructions can be found in Section 4. How am I given DOTAGRAF? in the full CMI.
5. What should I know while receiving DOTAGRAF?
Things you should do | Tell your doctor, radiographer or nurse if you:
|
Driving or using machines | DOTAGRAF may cause nausea which can affect your ability to drive and use machines. |
For more information, see Section 5. What should I know while receiving DOTAGRAF? in the full CMI.
6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.
Serious side effects can include nephrogenic systemic fibrosis (NSF), severe allergic reactions and heart attack.
Common side effects can include headache, pins and needles sensation, nausea, vomiting, injection site reaction, feeling weak/lack of energy, feeling warm/hot or cold sensation, itchy skin, red skin or a rash.
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.
WARNING: Gadolinium-based contrast agents can increase the risk of nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severely impaired kidney function either with or without liver impairment, cirrhosis or liver transplant. For more information, speak with your doctor, radiographer or nurse.
FULL CMI
DOTAGRAF® (DOH-ta-graph)
Active ingredient: gadoteric acid
Consumer Medicine Information (CMI)
This leaflet provides important information about using DOTAGRAF. You should also speak to your doctor, radiographer, nurse or pharmacist if you would like further information or if you have any concerns or questions about using DOTAGRAF.
Where to find information in this leaflet:
1. Why am I given DOTAGRAF?
2. What should I know before I am given DOTAGRAF?
3. What if I am taking other medicines?
4. How am I given DOTAGRAF?
5. What should I know while receiving DOTAGRAF?
6. Are there any side effects?
7. Product details
1. Why am I given DOTAGRAF?
DOTAGRAF contains the active ingredient gadoteric acid.
DOTAGRAF is a contrast agent used during a magnetic resonance imaging (MRI) examination. It aids in the detection of known or suspected abnormalities in the brain and body.
DOTAGRAF is a liquid that alters the way in which the MRI machine detects certain tissues within the body, often making the pictures clearer and showing things that may not have been visible using MRI alone.
2. What should I know before I am given DOTAGRAF?
Warnings
Do not use DOTAGRAF if:
- you are allergic to gadoteric acid, or any of the ingredients listed at the end of this leaflet.
- always check the ingredients to make sure you can use this medicine.
Check with your doctor, radiographer or nurse if you have:
- any other allergies (e.g. seafood, hay fever, hives, anaphylaxis)
- very poor kidney function or severe kidney problems
- had a liver transplant, impaired liver function or liver cirrhosis
- bronchial asthma
- severe heart and circulatory disorders
- low threshold for seizures
- a heart pacemaker or any material in your body containing iron
- are taking beta-blockers used for high blood pressure or heart conditions
- 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, radiographer or nurse if you are pregnant or intend to become pregnant.
There is no need to stop breastfeeding if you need an examination, but it is recommended to discard your milk for 24 hours after receiving DOTAGRAF.
Use in children
DOTAGRAF is approved for use in adults, adolescents and children.
3. What if I am taking other medicines?
Tell your doctor, radiographer, nurse 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 DOTAGRAF and affect how it works.
Tell your doctor, radiographer or nurse if you are taking a beta-blocker or another medicine used to treat high blood pressure or a heart condition.
If you experience an allergy-like reaction to DOTAGRAF, any treatment given to you may be affected by these medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DOTAGRAF.
4. How am I given DOTAGRAF?
How much to be given
- The dosage of DOTAGRAF is based on your weight and area of your body that will be examined. The doctor, radiographer or nurse will calculate the right dose for you.
When DOTAGRAF is given
- DOTAGRAF will be given immediately before or during your MRI examination.
How DOTAGRAF is given
- DOTAGRAF is injected by a small needle into a vein, usually in your hand or arm.
- DOTAGRAF should not be injected into your back.
If you are given too much DOTAGRAF
If you think that you have been given too much DOTAGRAF, ask the doctor, radiographer or nurse. As DOTAGRAF is given by the doctor, radiographer or nurse, overdose is unlikely. If it does happen, a doctor will treat any symptoms that follow.
If you currently have a problem with your kidneys or liver, the doctor may decide to remove DOTAGRAF from the body by means of a blood-cleansing procedure (dialysis).
You should immediately:
- phone the Poisons Information Centre (by calling Australia: 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 while receiving DOTAGRAF?
Things you should do
Follow carefully the directions given to you by your doctor and other medical staff.
Call your doctor straight away if you:
- experience any of the severe symptoms such as loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock
- have very poor kidney function or severe kidney problems
- had a liver transplant, impaired liver function or liver cirrhosis
- have severe heart and circulatory disorders
- have low threshold for seizures.
Remind any doctor, dentist or pharmacist you visit that you have been given DOTAGRAF.
Recent information shows that gadolinium (contained in DOTAGRAF) may build up in the brain after multiple uses and the effect on the brain is unknown right now. Your doctor will carefully consider whether to use repeated doses and will use the lowest dose of DOTAGRAF.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DOTAGRAF affects you.
DOTAGRAF may cause nausea which can affect your ability to drive and use machines.
Looking after your medicine
- The MRI unit will store DOTAGRAF under the conditions advised by the manufacturer.
- Shelf life and storage conditions are printed on the pack.
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.
Nephrogenic Systemic Fibrosis
If you have very poor kidney function or severe kidney disease, and you receive any gadolinium-containing contrast agent for an MRI, you may be at risk of developing a rare condition known as Nephrogenic Systemic Fibrosis (NSF). This condition can cause hardening (fibrosis) of the skin and tissues.
Allergic reaction
Some people may experience symptoms of an allergic reaction such as loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock.
Allergic reactions occur more frequently in people with a history of allergies to other contrast agents, to foods (e.g. seafood) or those who suffer from anaphylaxis, hay fever or bronchial asthma.
Most of these reactions occur within 60 minutes of receiving DOTAGRAF. Rarely, some of these reactions may be delayed (up to 7 days after receiving DOTAGRAF).
Less serious side effects
Less serious side effects | What to do |
Gastrointestinal disorders
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Immune system disorders
| 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. |
Tell your doctor, radiographer, nurse 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 in Australia 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 in an MRI unit.
What DOTAGRAF contains
Active ingredient (main ingredient) | Gadoteric acid |
Other ingredients (inactive ingredients) | Meglumine Tetraxetan (DOTA) Water for injections |
Do not take this medicine if you are allergic to any of these ingredients.
What DOTAGRAF looks like
DOTAGRAF is a clear, colourless to slightly yellow 0.5 mmol/mL solution for injection and is supplied in glass vials or bottles of various sizes. DOTAGRAF is latex-free.
10 mL vial – AUST R 351770
15 mL vial – AUST R 371170
20 mL vial – AUST R 371171
60 mL bottle – AUST R 371172
100 mL bottle – AUST R 371173
Not all presentations may be marketed in Australia.
Who distributes DOTAGRAF
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
www.bayer.com.au
This leaflet was prepared in July 2024.
See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.
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Published by MIMS September 2024