MAGNEVIST Rx

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MAGNEVIST

Imaging agents
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Generic Name and Formulations:

Gadopentetate dimeglumine 469.01mg/mL; soln for IV inj; preservative-free.

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Indications for MAGNEVIST:

For use in MRI to facilitate the visualization of lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues; in the head and neck; and in the body (excluding the heart).

Adults and Children:

<2yrs: not established. ≥2yrs: 0.1mmol/kg (0.2mL/kg) IV at a rate of 10mL/15secs, followed by a 5mL normal saline flush (to ensure complete injection). Patients >286 lbs: dose not established.

Contraindications:

Chronic, severe kidney disease (GFR<30mL/min/1.73m2). Acute kidney injury.

Warnings/Precautions:

Increased risk of nephrogenic systemic fibrosis among patients with renal impairment (eg, >60yrs, diabetes mellitus, chronic hypertension). Screen for renal dysfunction. Acute renal failure possible in patients with renal insufficiency within 48hrs of inj; use lowest possible dose and evaluate renal function. Do not exceed recommended dose; allow sufficient period of time for elimination prior to re-administration. History of asthma and/or allergy disorders. Have resuscitative equipment available. Discontinue if hypersensitivity reactions occur. Interpreting Magnevist MRI scans without a companion non-contrast MRI scan. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Paramagnetic contrast agent (Gadolinium-based).

Adverse Reactions:

Headache, nausea, inj site coldness/localized coldness, dizziness; rare: inj site reactions, hypersensitivity reactions.

How Supplied:

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