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DOTAREM
Imaging agents
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Drug Name:

DOTAREM Rx

Generic Name and Formulations:
Gadoterate meglumine 376.9mg/mL (0.5mmol/mL); soln for IV inj; preservative-free.

Company:
Guerbet LLC

Therapeutic Use:

Indications for DOTAREM:

For use in MRI of the brain (intracranial), spine and associated tissues in adults and children (including term neonates) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity.

Adults and Children:

Preterm neonates: not established. Give by IV bolus inj at a rate of ~2mL/sec (adults) or 1–2mL/sec (neonates/children), manually or by power injector. 0.2mL/kg (0.1mmol/kg), followed by a normal saline flush to ensure complete injection.

Boxed Warning:

Nephrogenic systemic fibrosis.

Warnings/Precautions:

Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury; avoid use. Screen for renal dysfunction. Do not exceed recommended dose and allow sufficient time for drug elimination before re-administration. Have emergency resuscitative equipment available. History of asthma or other allergic disorders. Monitor for signs/symptoms of hypersensitivity reactions during and after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Avoid extravasation. Elderly. Pregnancy. Nursing mothers.

Pharmacological Class:

Gadolinium-based contrast agent.

Adverse Reactions:

Nausea, headache, inj site pain, inj site coldness, rash; hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Single-dose vials (5mL, 10mL, 15mL, 20mL)—10; Pre-filled syringes (10mL, 15mL, 20mL)—5

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