Consumer Medicine Information
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Please read this leaflet carefully before you are given an injection of DOTAREM. It tells you some of the more important points you need to know about this product.
If you have any questions, want to know more about DOTAREM or are unsure about anything, ask your specialist or radiologist. This leaflet provides only a summary of the information known about DOTAREM.
Remember that this injection is only for you. Only a doctor can prescribe it for you.
WHAT IS IN THE INJECTION
DOTAREM injection contains 279.32 mg/mL of gadoteric acid as the active ingredient. It also contains the inactive ingredients meglumine and water for injections.
WHAT DOTAREM IS USED FOR
DOTAREM contains gadoteric acid, which is made from gadolinium oxide (a magnetic agent) and DOTA, which binds with the gadolinium oxide to make a contrast agent to help diagnosis in MRI (magnetic resonance imaging).
This is injected into your veins just before a MRI examination.
BEFORE RECEIVING IT
When you must not be given it
You must not be given DOTAREM if you have:
- ever had an allergic (hypersensitive) reaction to the active substance, gadoteric acid, or to the other ingredients in DOTAREM. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.
- any metallic foreign objects in your body such as a pacemaker or vascular clips. Before the examination, remove all metallic objects that you wear. This is very important because metals could cause serious disorders, since MRI machines use very strong magnetic fields.
Before you are given it
Tell your doctor know if you are allergic to any other medicines or any foods, dyes or preservatives.
Tell your doctor if you have or have had any of the following medical conditions:
- kidney disease
- you have had or will soon have a liver transplant
There have been reports of a serious disease called nephrogenic systemic fibrosis (NSF) in kidney disease and liver transplant patients when they have used these types of products.
Tell your doctor if you are pregnant, breast feeding or if you are likely to become pregnant shortly.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with DOTAREM Injection. These include medicines used to treat hypertension.
HOW IT IS GIVEN
How much is given
The doctor will determine the dose that you will receive and will supervise the injection. The usual dose for adults, children and infants is 0.2 mL/kg.
How it is given
DOTAREM will be given to you as a single intravenous injection. You will be monitored for any side effects for at least 30 minutes after the injection.
When opened, this product should be used once only and any residue discarded.
IF TOO MUCH IS GIVEN (OVERDOSE)
As you will be administered the injection under the supervision of your doctor in a hospital, it is highly unlikely that you will be given too much.
However, if you experience any side effects after being given DOTAREM Injection, tell your doctor or nurse immediately. You may need urgent medical attention.
Also, immediately tell the doctor or nurse if you think a child or anyone else has accidentally taken any of this medicine.
DOTAREM, like most other medicines and diagnostic agents can cause side effects in some people. These side effects are usually mild to moderate and short-lasting.
Most side effects occur during injection or during the first hour after the injection. Some side effects may appear several days after the injection of DOTAREM.
The most common side effects during administration of DOTAREM include headache, tingling sensation, sensation of warmth or cold and/or pain at the injection site, nausea, vomiting and mild allergic reactions (usually affecting the skin such as rash and itchiness).
Tell your doctor immediately if you notice sudden signs of serious allergy, such as swelling of the face, lips or tongue or other parts of the body, shortness of breath, wheezing or trouble in breathing.
If you have them, you may have had a serious allergic reaction to DOTAREM. This serious side effect is rare.
There have been isolated reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may also affect soft tissues and internal organs).
Tell your doctor if you notice anything else that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet. Other side effects not listed above may also occur in some people.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
AFTER USING IT
As this is being given to you by your doctor, it is extremely unlikely that you will be expected to look after the injection. However, in the case that you may have to transport it from the pharmacy to your doctor, it is important to store it in a safe place, away from light, where the temperature stay below 30ºC. The pre-filled DOTAREM syringes should not be frozen.
Do not use DOTAREM if the packaging is torn or shows signs of tampering or after the expiry date printed on the label.
Keep all medicines in a safe place where children cannot reach them. They may be dangerous to children.
What it looks like
DOTAREM is a clear, colourless to yellow solution available in a glass vial or pre-filled syringe intended for intravenous injection.
DOTAREM is registered in vials of 5 mL, 10 mL, 15 mL and 20 mL, but only the 10 mL vial is currently available.
DOTAREM is also registered in pre-filled syringes of 10 mL, 15 mL and 20 mL, but only the 10 mL prefilled syringe is currently available.
The Australian Registration numbers are AUST R 76923, 76924, 76925, 76926, 160798, 160799 and 160800.
Apollo Imaging Solutions Pty Ltd, 138 Victoria Road, Bellevue Hill, NSW 2023, Australia.
This leaflet was revised on 7 May 2015.
Published by MIMS August 2017