GADOVIST 1.0 gadobutrol 6.0472g/10mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gadobutrol, Quantity: 604.72 mg/mL

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; water for injections; calcobutrol; trometamol

Administration route:

Intravenous

Units in package:

5 x 10mL syringes

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This medicinal product is for diagnostic use only. Gadovist 1.0 is indicated in adults and children including full-term newborns for: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) Contrast enhancement in whole body MRI including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system Use in first-pass MRI studies of cerebral perfusion (see PRECAUTIONS) Contrast enhancement in magnetic resonance angiography (CE MRA) (see CLINICAL TRIALS) Contrast enhancement in cardiac MRI including assessment of rest and pharmacological stress perfusion and delayed enhancement

Product summary:

Visual Identification: Clear, colourless to slightly yellow solution.; Container Type: Syringe; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-01-17

Patient Information leaflet

GADOVIST® 1.0
1
GADOVIST® 1.0
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 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?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you have:
•
experience any of the severe symptoms of 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,

Summary of Product characteristics

210628 GADOVIST 1.0 PI
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
GADOVIST
® 1.0 (GADOBUTROL)
1.
NAME OF THE 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
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Gadovist 1.0 is indicated in adults and children including full-term
newborns for:
•
Contrast enhancement in cranial and spinal magnetic resonance imaging
(MRI)
•
Contrast enhancement in whole body MRI including head and neck region,
thoracic space,
breast, abdomen (pancreas, liver and spleen), pelvis (prostate,
bladder and uterus),
retroperitoneal space (kidney), extremities and musculoskeletal system
•
Use in first–pass MRI studies of cerebral perfusion (see section 4.4
Special Warnings and
Precautions for Use)
•
Contrast enhancement in magnetic resonance angiography (CE MRA) (see
section 5.1
Clinical Trials)
•
Contrast enhancement in cardiac MRI including assessment of rest and
pharmacological
stress perfusion and delayed enhancement.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
This medicinal product is for intravenous administration only. The
dose required is administered
as a bolus dose. The lowest effective dose should be used.
Contrast-enhanced MRI can usually
commence shortly after the injection depending on the pulse sequences
used and the protocol
for the examination. Optimal signal enhancement is observed during
arterial first pass for CE-
MRA and within a period of about 15 minutes after injection of
Gadovist 1.0 for other indications
(depending on the type of lesion and tissue).
Gadovist 1.0 should not be drawn into the syringe and the prefilled
syringe