Consumer medicine information

1. Why am I given GADOVIST 1.0?

GADOVIST 1.0 contains the active ingredient gadobutrol. GADOVIST 1.0 is a contrast agent used during a magnetic resonance imaging (MRI) examination.
For more information, see Section 1. Why am I given GADOVIST 1.0? in the full CMI.

2. What should I know before I am given GADOVIST 1.0?

Do not use if you have ever had an allergic reaction to GADOVIST 1.0 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 GADOVIST 1.0? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with GADOVIST 1.0 and affect how it works.
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 GADOVIST 1.0?

GADOVIST 1.0 is injected into your vein by a doctor, radiographer or nurse immediately before or during your MRI examination. It is recommended that you do not eat for 2 hours before you are given GADOVIST 1.0.
More instructions can be found in Section 4. How am I given GADOVIST 1.0? in the full CMI.

5. What should I know while receiving GADOVIST 1.0?

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 severe allergic reactions, breathing or lung issues, nephrogenic systemic fibrosis (NSF) and heart attack. Common side effects can include headache, nausea and dizziness.
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.

Boxed Warnings

Nephrogenic systemic fibrosis. Gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:
Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m²), or
Acute renal insufficiency of any severity due to the hepatorenal syndrome or in the perioperative liver transplantation period.
See Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use.

1 Name of Medicine

Gadobutrol.

2 Qualitative and Quantitative Composition

Gadovist 1.0 is available as a 1.0 mmol/mL solution for injection and each mL of Gadovist 1.0 contains 604.72 mg (1.0 mmol) gadobutrol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Gadovist 1.0 solution for injection is a clear, colourless to pale yellow solution and contains no antimicrobial preservative.

4 Clinical Particulars

4.9 Overdose

No signs of intoxication secondary to an overdose have so far been reported during clinical use. Single doses of gadobutrol as high as 1.5 mmol gadobutrol/kg body weight were well tolerated. In case of inadvertent overdosage, cardiovascular monitoring (including ECG) and control of renal function are recommended as a measure of precaution.
Gadovist 1.0 can be removed from the body by haemodialysis (see Section 4.4 Special Warnings and Precautions for Use).
For information on the management of overdose, contact:
Australia: The Poison Information Centre on 131126 (Australia).
New Zealand: The National Poisons Centre on 0800 POISON (0800 764766).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Nonclinical safety data. Non-clinical data reveal no special hazard for humans based on conventional studies of systemic toxicity, genotoxicity, and contact-sensitizing potential.
Experimental local tolerance studies in animals following a single paravenous, subcutaneous, or intramuscular application indicated that slight local intolerance reactions could occur at the administration site after inadvertent paravenous administration.
In nonclinical cardiovascular safety pharmacology studies, depending on the dose of gadobutrol administered, transient increases in blood pressure and myocardial contractility were observed. As these effects were minimal and transient, and due to anaesthesia of the animals, they are not considered relevant to humans. In humans, no increase in blood pressure was observed in clinical studies.
Genotoxicity. Bacteria, mammalian cells and animal studies investigating the genotoxicity (gene mutation and chromosomal aberration) of gadobutrol in vitro and in vivo did not show genotoxic potential.
Carcinogenicity. The carcinogenic potential of gadobutrol has not been investigated in long-term animal studies.
Studies in neonatal/juvenile animals. Single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in children of all ages including full-term newborns and infants.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Gadovist 1.0 (gadobutrol) solution for injection is the complex consisting of gadolinium (III) and the macrocyclic dihydroxy-hydroxymethylpropyl-tetraazacyclododecane-triacetic acid (butrol), and is an injectable neutral contrast medium for magnetic resonance imaging (MRI). Gadobutrol is to be administered by intravenous injection.
Chemical structure. Gadovist 1.0 injection is a 1.0 mmol/mL solution of 10-(2,3-dihydroxy-1- hydroxymethylpropyl)1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid, Gd-complex, with a molecular weight of 604.7 and has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGADOBU.gif CAS number. 138071-82-6.
Physicochemical properties. See Table 11.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/GADOVI11.gif Gadovist 1.0 solution has a pH of 6.6 to 8.0.

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.
New Zealand: General Sales Medicine.

Summary Table of Changes

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