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References: 1.

Voth M et al. Invest Radiol 2011;46:663-671 Safety of Gadobutrol, a New Generation of Contrast Agents. Experience from clinical trials and postmarketing surveillance

Australian Approved

Product Information - Date of preparation: 14 January 2015

Frenzel et al. Invest Radiol 2008;43:817-828 Stability of Gadolinium-Based Magnetic Resonance Imaging Contrast Agents in Human Serum at 37°C.

What Matters Most

Established safety profile, well tolerated

& approved for a broad range of clinically

relevant indications and doses for adults

& children ≥ 2 years

#1,2

# Gadovist® 1.0 is approved for children aged 2 – 17 years;

not recommended for use in children below 2 years due to

a lack of data on efficacy and safety

Macrocyclic contrast – belongs to

class of gadolinium agents with highest

stability vs ionic & non-ionic classes

Minimum Product Information GADOVIST

1.0 [gadobutrol 1.0 mmol/mL]

INDICATIONS:

Adults, adolescents and children aged 2 years and over 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*; first–pass MRI studies of cerebral perfusion; contrast enhancement in magnetic resonance angiography (CE MRA); contrast enhancement in cardiac MRI

including assessment of rest and pharmacological stress perfusion and delayed enhancement*.

CONTRAINDICATIONS:

known hypersensitivity to gadobutrol or any of the ingredients.

PRECAUTIONS:

Severe renal impairment and liver transplant patients (see boxed warning); pronounced states of excitement, anxiety and pain may increase the risk or intensity of

adverse reactions; anaphylactoid/hypersensitivity or other idiosyncratic reactions (higher risk in the case of previous reaction to contrast media, history of bronchial asthma, history of

allergic disorders); severe cardiovascular disease; patients with a low threshold for seizures; limited MRI studies of cerebral perfusion; not recommended for use in children below 2 years

of age; pregnancy (Category B3).

ADVERSE EFFECTS:

most common: headache; nausea; dizziness. Please refer to PI for a complete list.

BOXED WARNING:

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/1.73m2; or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. D

OSAGE AND ADMINISTRATION:

Cranial and spinal MRI: 0.1 mL/kg body weight given intravenously at a rate of 2 mL per second. Maximum total amount of 0.3 mL/kg body weight may be administered. CE MRI of the

whole body*: 0.1 mL/kg body weight. Cerebral perfusion studies: for gradient echo sequences 0.1 - 0.3 mL/kg body weight given intravenously at a rate of 5 mL per second using a

powered injector. CE MRA: Imaging of one field of view: Less than 75 kg body weight: 7.5 mL, greater than or equal to 75 kg body weight: 10 mL; Imaging more than one field of view:

Less than 75 kg body weight: 15 mL, greater than or equal to 75 kg body weight: 20 mL. CE Myocardial perfusion imaging and delayed enhancement*: 0.05 mL/kg body weight during

pharmacological stress and 0.05 mL/kg body weight at rest; for delayed enhancement only, a total dose of 0.1 mL/kg body weight. Children (above 2 years of age) and adolescents:

0.1 mL/kg body weight for all indications. Renal impairment: Do not exceed the recommended dose*.

DATE OF PREPARATION:

January 2015.

Please review the full Product Information before administering. Approved PI available at http://www.

bayerresources.com.au/resources/uploads/PI/file9345.pdf

or upon request from Bayer Australia Ltd

Bayer Australia Ltd,ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073. ® Registered trademark of the Bayer Group, Germany. LAU.MKT.DI.12.2015.0067 December 2015.

*Please note change(s) in Product Information.